Effectiveness Not Established

Ginger

for Chemotherapy-Induced Nausea and Vomiting—Adult

Ginger is a plant herb used in traditional Chinese and Indian medicine for the treatment of nausea and vomiting. Ginger has aromatic, spasmolytic, carminative, and absorbent properties that suggest direct effects on the gastrointestinal tract. Ginger has been evaluated for management of chemotherapy-induced nausea and vomiting (CINV).

Systematic Review/Meta-Analysis

Ernst, E., & Pittler, M.H. (2000). Efficacy of ginger for nausea and vomiting: A systematic review of randomized clinical trials. British Journal of Anaesthesia, 84, 367-71.

Search Strategy

  • Databases searched were MEDLINE, Embase, Biosis, CISCOM, and Cochrane Library.
  • Searched keywords were ginger, herbal remedy, nausea, and vomiting.

Literature Evaluated

The review identified three studies on postoperative nausea, one for seasickness, one for morning sickness, and one for chemotherapy-induced nausea and vomiting (CINV). Studies were performed in the United States and in Denmark.

Sample Characteristics

The total number of participants in the studies was 288 for postoperative nausea, 30 for morning sickness, 80 for seasickness, and 41 for CINV.

Conclusions

Clinical data was insufficient to draw a firm conclusion on the benefits of ginger for nausea and vomiting.

Nursing Implications

Although no adverse events were reported in these studies, ginger may have an adverse effect. A German monograph reported that ginger may be mutagenic in pregnancy.

Print

Lee, J., & Oh, H. (2013). Ginger as an antiemetic modality for chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis. Oncology Nursing Forum, 40, 163-170.

Purpose

To review and evaluate the evidence on the effect of ginger as a modality for management of chemotherapy-induced nausea and vomiting (CINV)


 

Search Strategy

Databases searched were MEDINE, CINAHL, Embase, Cochrane central register, Korean Studies information service system, and dissertation central.

Search keywords were chemotherapy, nausea, vomiting, chemotherapy induced nausea and vomiting, ginger, ginger extract and Zingiver officinale.

The reference lists of retrieved articles also were reviewed.

The inclusion criteria were not specifically stated, but all studies were double blind randomized controlled trials (RCTs).

The exclusion criteria were not stated. However, specific studies that combined ginger with another treatment, did not include sufficient information about the sample and intervention, and examined outcomes per episode of chemotherapy rather than by patient were excluded.

Literature Evaluated

  • A total of 11 RCTs were initially identified.
  • Reviewers used the Jadad scale to evaluate study quality.

 

Sample Characteristics

  • Five studies were included in the final review.
  • Study samples ranged from 17-576 patients.
  • Studies involved various cancer types and various chemotherapy emetic potentials.

Phase of Care and Clinical Applications

All patients were in active antitumor treatment.

Results

Three of the studies compared ginger to placebo, and two compared it to metoclopramide or ondansetron. Most of the trials did not use an NK1 in the antiemetic regimen, which is the current recommended guideline. Side effects reported with ginger included drowsiness, sleepiness, dry mouth, thirst, heartburn or restlessness. One study reported bruising, flushing, or rash. Meta-analyses concluded that ginger had no significant effect on control of acute or delayed nausea or vomiting.

Conclusions

Results do not support the use of ginger and did not show an antiemetic effect of ginger for management of CINV.

Limitations

  • The number of studies included in the review was limited.
  • The meta analysis had high heterogeneity. 
  • Not all studies specified the chemotherapy used and one study combined use with low, moderate, and high emetogenic chemotherapy regimens. 
  • Most antiemetic regimens used with ginger did not incorporate current treatment guidelines for CINV.

Nursing Implications

Ginger does not appear to be effective for the management of CINV.

Print

Marx, W.M., Teleni, L., McCarthy, A.L., Vitetta, L., McKavanagh, D., Thomson, D., & Isenring, E. (2013). Ginger (Zingiber officinale) and chemotherapy-induced nausea and vomiting: A systematic literature review. Nutrition Reviews, 71, 245-254.

Purpose

To review the current published research from randomized controlled trials (RCTs) and crossover trials evaluating the efficacy of ginger for prevention of chemotherapy-induced nausea and vomiting (CINV)

Search Strategy

Databases searched were PubMed, CINAHL, and Cochrane library.

Search keywords were ginger, cancer , chemotherapy, nausea, emesis, vomiting, and CINV.

Studies were included in the review if they

  • Were RCTs or crossover trials.
  • Involved ginger as the main intervention.
  • Were in English language.

Study exclusions were not reported.

Literature Evaluated

  • A total of 27 references were initially retrieved.
  • Studies were rated using the National Health and Medical Research Council hierarchy of evidence. 
  • The overall body of evidence was rated according to the American Dietetic Association quality criteria checklist.

Sample Characteristics

  • Seven studies were included in the final review.
  • Sample sizes ranged from 36-576 patients in each trial for a total of 1,013 patients across all studies.
  • One study was of children. Samples included male and female participants.

Phase of Care and Clinical Applications

  • All patients were in active antitumor treatment.
  • The report has applications for pediatrics.

Results

  • Four studies reported positive results with ginger, and three showed no benefit. 
  • Varied ginger doses were used, and various comparisons were used.
  • Only one study involved use of a 5-HT3 or other recommended CINV treatment in the regimen. 
  • All studies were rated as level II (with level I as the highest level); however, not all studies reported how CINV was measured, and one involved multiple emetogenicity levels.

Conclusions

At best, findings show mixed results for use of ginger.  Overall body of evidence was rated as “C’ in which “D” was the lowest possible level.

Limitations

  • The number of studies was limited.
  • The quality rating method used was questionable, because all studies were highly rated for quality but some did not even define the method of CINV measurement. 
  • The review did not take into account what treatments were used for control comparisons, and many did not include recommended treatments.

Nursing Implications

This review does not support the use of ginger for CINV prevention.

Print

Research Evidence Summaries

Ansari, M., Porouhan, P., Mohammadianpanah, M., Omidvari, S., Mosalaei, A., Ahmadloo, N., . . . Hamedi, S. H. (2016). Efficacy of ginger in control of chemotherapy induced nausea and vomiting in breast cancer patients receiving doxorubicin-based chemotherapy. Asian Pacific Journal of Cancer Prevention, 17, 3877–3880.

Study Purpose

To evaluate the efficacy of adding powdered ginger to prevent chemotherapy-induced nausea and vomiting (CINV) in women with breast cancer receiving moderately emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

Women with breast cancer were randomized to receive either 500 mg ginger or placebo twice a day for three days, during the course of three cycles of chemotherapy.

Sample Characteristics

  • N = 150 patients (450 chemotherapy cycles)  
  • MEAN AGE = 48.6 years
  • AGE RANGE = 25-79 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy-naïve patients receiving at least three cycles of doxorubicin-based chemotherapy

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Namazi Hospital in Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Double-blind, randomized, longitudinal

Measurement Instruments/Methods

Not described; only states that participants were asked to “record the episodes of vomiting and nausea severity”

Results

No significant difference in nausea or vomiting existed when comparing the ginger group to the placebo group.

Conclusions

The results of this study do not indicate that powdered ginger capsules (1 g daily) are effective in reducing CINV in women with breast cancer receiving chemotherapy.

Limitations

Measurement/methods not well described

Nursing Implications

Powdered ginger capsules may not offer CINV relief for patients receiving chemotherapy.

Print

Arslan, M., & Ozdemir, L. (2015). Oral intake of ginger for chemotherapy-induced nausea and vomiting among women with breast cancer. Clinical Journal of Oncology Nursing, 19, E92–E97. 

Study Purpose

To determine the effects of ginger on chemotherapy-induced nausea and vomiting (CINV) in women receiving adjuvant anthracycline for breast cancer

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to control and treatment groups. Women in the intervention group consumed 500 mg of powdered ginger mixed with yogurt twice daily after an initial dose 30 minutes prior to chemotherapy. Both groups received triplet antiemetic therapy. Patients were followed for five days and were asked to record episodes of vomiting and retching and to evaluate their nausea using a numeric 10-point scale four times per day in a diary. The numeric scale also was used on the first day of chemotherapy to collect baseline data. Patient diaries were collected at the end of the five-day study period.

Sample Characteristics

  • N = 60  
  • MEAN AGE = 48.5 years (range = 49–58 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All patients were receiving adjuvant anthracycline, were currently receiving triplet antiemetics, and experienced grade 3 or higher CINV during the previous cycle of chemotherapy.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Numeric Rating Scale (NRS) for nausea
  • Patient diary 

Results

Nausea severity was significantly lower in the experimental group after the intervention on study days 2–5 (p = 0.0001). The number of vomiting episodes also was lower in the experimental group on some study days (p < 0.05).

Conclusions

The use of ginger as an adjuvant to triplet antiemetics among women receiving anthracycline-based chemotherapy resulted in lower acute and delayed nausea severity.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)

 

Nursing Implications

Advances in antiemetic drugs have substantially improved the prevention and control vomiting in the acute and delayed phases of CINV. However, the prevention of nausea has been difficult to achieve. Findings from this study suggest that the use of ginger in combination with triplet antiemetics can be beneficial in reducing the severity of nausea.

Print

Bossi, P., Cortinovis, D., Fatigoni, S., Cossu Rocca, M., Fabi, A., Seminara, P., . . . Roila, F. (2017). A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin. Annals of Oncology, 28, 2547–2551.

Study Purpose

To determine the effectiveness of ginger on the incidence and intensity of delayed nausea for patients on HEC (cisplatin)

Intervention Characteristics/Basic Study Process

Patients scheduled to receive high-dose cisplatin for two or more chemotherapy cycles were randomized to receive standardized ginger preparation 120 mg per day [two capsules of 40 mg twice daily] (16 mg gingerols plus 1.12 mg shogaoil) or placebo in addition to standard antiemetics (NK1 RA and 5-HT3 RA on day 1 and dexamethasone on days 1-4) for a period of two chemotherapy cycles; nearly 45 days.

Sample Characteristics

  • N = 244 patients (121 ginger; 123 placebo)    
  • AGE: Mean = 59.2 years
  • MALES: 65.6% (ginger 68.6%, placebo 62.6%)  
  • FEMALES: 34.4% (ginger 31.4%, placebo 37.4%)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Chemotherapy naïve, solid tumor (lung, head and neck cancer, planned to receive two or more cycles of > 50 mg cisplatin) 
  • OTHER KEY SAMPLE CHARACTERISTICS: No ANV before fist HEC cycle

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Six Italian oncology centers

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Randomized, double-blind, placebo-controlled

Measurement Instruments/Methods

Visual analog scale, 0–100 mm for nausea incidence and intensity, Functional Living Index Emesis (impact of nausea am daily living), Brief Fatigue Inventory questionnaire (impact of fatigue)

Results

No significant differences between the two groups in relation to incidence of delayed nausea, intercycle nausea, and anticipatory nausea during the first and second cycle. In ginger group; men with lung cancer experienced a higher incidence of significant delayed and intercycle nausea (p < 0.05), incidence of delayed nausea was higher among patients with lung cancer in the ginger group than placebo (p = 0.042), no differences in FLIE and BFI between the two groups; a benefit of ginger over placebo in terms of FLIE for female versus male patients and in head/neck cancer versus lung cancer. No differences in experienced adverse effects between the two groups.

Conclusions

Ginger had no beneficial effect in reducing CINV (delayed, anticipatory, and intercycle) associated with HEC.

Limitations

  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: No stratification for the gender and the age group; using HEC, using VAS to measure incidence and intensity of nausea, not measuring the acute nausea, using a standardized ginger extract is impractical and could affect the generalizability

Nursing Implications

Daily ginger is safe; some patient might experience an increase in gastrointestinal symptoms.

Print

Konmun, J., Danwilai, K., Ngamphaiboon, N., Sripanidkulchai, B., Sookprasert, A., & Subongkot, S. (2017). A phase II randomized double-blind placebo-controlled study of 6-gingerol as an anti-emetic in solid tumor patients receiving moderately to highly emetogenic chemotherapy. Medical Oncology, 34, 69.

Study Purpose

To determine the effectiveness of standardized bioactive compound of ginger extract (6-Gingerol) on CINV in solid tumor patients receiving MEC to HEC in addition to standard antiemetics (ondansetron, metoclopramide, and dexamethasone) in solid tumor patients

Intervention Characteristics/Basic Study Process

Patients were randomized to receive 10 mg ginger extract capsule (6-gingerol) or a matching placebo twice daily three days before prior to chemotherapy to D1 and continued for 12 weeks; in addition to standard antiemetics. For HEC regimen, D1 (ondansetron 8 mg IV plus dexamethasone 12 mg IV) and oral daily on days 2 to 4. For MEC regimen, D1 (ondansetron 8 mg IV plus dexamethasone 8 mg IV) and oral daily on days 2 to 4. All patients received metoclopramide 10 mg orally three times daily on days 2 to 4. Rescue antiemetics were allowed at any time. Intensity of nausea and appetite was measured daily by the numeric rating scale. Also, patients recorded nausea and vomiting events daily from day 0 to 120 hours after each chemotherapy cycle. QOL measured by (FACT-G) instrument at days 1, 22, 43, and 64 of treatment.

Sample Characteristics

  • N = 96; 81 patients remained for analysis (excluded before initial treatment or on week 1)   
  • AGE: median = 53 years (range = 19-81) 
  • MALES: 7%  
  • FEMALES: 93%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Solid tumor, older than age 18 years, newly diagnosed 
  • OTHER KEY SAMPLE CHARACTERISTICS: Scheduled to receive three consecutive chemotherapy cycles after surgical resection, not on NK1 RA regimen

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Thailand

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Multicenter randomized, double-blind, placebo-controlled phase II study

Measurement Instruments/Methods

Intensity of nausea and appetite was measured daily by the numeric rating scale using the Edmonton Symptom Assessment Scale (ESAS), ranging from 0 to 10. Quality of life will be measured by using version 4 of the Functional Assessment of Cancer Therapy-General (FACT-G). Daily diary from days 1-5 in each chemotherapy cycle (this includes number of vomiting episodes, nausea score, appetite score, QOL, use of rescue antiemetic, and hospitalization).

Results

The overall CR rate was significantly higher in patients treated with 6-gingerol compared with placebo (p = 0.001) in both acute (p = 0.003) and delayed (p = 0.001) phases. However, during the first chemotherapy cycle, there was no statistically significant differences. Patient received 6-gingerol reported improvement in appetite (p = 0.001) and less severity of overall nausea p < 0.001 and statistical improvement in QOL (p < 0.001) compared to placebo. Ginger was well tolerated with no observed adverse effect.

Conclusions

Prolonged and continuous daily dosing of 6-gingerol appears to be effective. 6-gingerol improved patient’s appetite and QOL; it is safe and well tolerable

Limitations

  • Small sample (< 100)
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%

Nursing Implications

Ginger is safe and well tolerable complementary therapy for patient on MEC-HEC. It also improve patient appetite and QOL.

Print

Levine, M.E., Gillis, M.G., Koch, S.Y., Voss, A.C., Stern, R.M., & Koch, K.L. (2008). Protein and ginger for the treatment of chemotherapy-induced delayed nausea. Journal of Alternative and Complementary Medicine, 14, 545–551.

Study Purpose

To determine the extent to which protein meals along with ginger, when used as adjuvant therapies for standard antiemetic treatment, reduce delayed nausea

Intervention Characteristics/Basic Study Process

Patients were assigned randomly to 1 of 3 experimental groups. The Protein (P) and High Protein (HP) Groups received test meals of varying protein content and dried powdered ginger root in addition to standard antiemetic medication; the Control Group received only standard antiemetic medication.

The P and HP Groups were asked to consume two test meals daily for three days beginning 24 hours after their first chemotherapy session. Patients in the Control Group consumed their normal diet.

Patients completed daily diaries during the three-day study. Investigators called patients daily to monitor for adverse events, answer questions, remind patients to eat the test meals, and remind them to complete diaries.

Sample Characteristics

  • The study consisted of 28 participants.
  • Patient ages ranged from 29–83 years with a mean of 54.3 years.
  • The majority of patients were female (75%).
  • Cancer diagnoses were breast, Hodgkin and non-Hodgkin lymphoma, bladder, lung, gastric, and prostate.
  • Patients were treated with 13 different chemotherapy regimens using six different types of antiemetics.
  • Patients were receiving their first chemotherapy treatment with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).

Setting

The setting was not reported.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized controlled trial, non-blinded study.

Measurement Instruments/Methods

An Electrogastrogram Symptom Diary was used to report nausea symptoms incidence, frequency, and intensity. Patients also recorded use of as-needed antiemetics.

Results

  • Reports of nausea, frequent nausea, and bothersome nausea were significantly less common (p < 0.01) among the HP Group patients than among the Control and P Group patients.
  • Significantly fewer patients in the HP Group used antiemetic medication (p < 0.05). The differences between the P and Control groups were not statistically significant.
  • In the five patients who had tests of gastric myeoelectrical activity performed, a significant decrease in gastric dysrhythmia occurred after ingestion of the protein and ginger (p <  0.05).

Conclusions

High-protein meals with ginger reduced delayed nausea associated with chemotherapy and use of antiemetic medications.

Limitations

  • The sample size was small.
  • A standardized measurement tool for report of nausea was not used.
  • Conclusions cannot be drawn on the role of ginger in reducing nausea because of possible interactions between ginger and high doses of protein.
  • Samples were widely variable in terms of cancer types, cytotoxic agents, and prescribed antiemetic medications.
  • The study lacked an adequate control group for the ginger component of the test meals and a placebo meal that contained neither ginger nor protein.
  • Daily phone calls to patients from investigators may have skewed results.

Nursing Implications

The limitations of this study limit the ability to draw conclusions for nursing practice.

Print

Li, X., Qin, Y., Liu, W., Zhou, X.Y., Li, Y.N., & Wang, L.Y. (2018). Efficacy of ginger in ameliorating acute and delayed chemotherapy-induced nausea and vomiting among patients with lung cancer receiving cisplatin-based regimens: A randomized controlled trial. Integrative Cancer Therapies, 17, 747–754.

Study Purpose

To determine the effectiveness of a standardized low-dose ginger supplement in addition to standard antiemetic therapy decreased the incidence of acute and delayed CINV in patients with lung cancer receiving chemotherapy regimens containing cisplatin

Intervention Characteristics/Basic Study Process

Patient randomly allocated to receive ginger root powder taken orally in the dose of 250 mg twice daily for five days starting 30 minutes prior to the start of chemotherapy or identical placebo in addition to standard antiemetics therapy (5HT3 RA)

Sample Characteristics

  • N: 140   
  • AGE: 57
  • MALES: 71%  
  • FEMALES: 29%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Cisplatin-based regimen

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Peking, China

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized, double-blind, placebo controlled

Measurement Instruments/Methods

Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool; Functional Assessment of Cancer Therapy-General (QOL)

Results

There was no significant difference between the intervention group and the control group in the incidence and severity of acute and delayed CINV or quality of life.

Conclusions

The use of a standardized ginger product with standardized antiemetic protocols produced no additional benefit in improving the incidence and severity of CINV in patients with lung cancer receiving chemotherapy regimens containing cisplatin.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: No control for at what point the intervention was initiated in each patients’ chemotherapy cycle so that patients who experienced CINV with previous cycles of chemotherapy are more likely to have CINV. No stratification for the previous experience of CINV. There was some difficulty in blinding because patients could smell the ginger. There also was no control of the among of dietary ginger that patients used during the study. Using a standardized dose of ginger which contains 5% gingerol could affect generalizability.

Nursing Implications

Although nurses have historically recommended ginger-containing products to relieve nausea, a standardized dose of ginger extract demonstrated no efficacy.

Print

Manusirivithaya, S., Sripramote, M., Tangjitgamol, S., Sheanakul, C., Leelahakorn, S., Thavaramara, T., et al. (2004). Antiemetic effect of ginger in gynecologic oncology patients receiving cisplatin. International Journal of Gynecologic Cancer, 14, 1063-1069.

Study Purpose

To determine the potential antiemetic effect of ginger in cisplatin-induced emesis

Intervention Characteristics/Basic Study Process

Patients were randomized to one of two groups. In regimen A, patients received 1 g of ginger per day for five days starting on the first day of chemotherapy. In regimen B, patients received a placebo on day one and metoclopramide on days two through five.

Sample Characteristics

  • The study consisted of 48 patients.
  • All patients were female.
  • All patients were being treated for gynecologic cancers and were receiving cisplatin chemotherapy.

Setting

The study was conducted in Bangkok, Thailand.

Measurement Instruments/Methods

Investigators assessed nausea and vomiting on day one. On days 2-5, patients recorded the presence and intensity of emetic episodes on diary cards.

Results

In regimen A, no effect was found in acute or delayed treatment. In regimen B, ginger had the same control as 40 mg metoclopramide for delayed nausea.

Limitations

  • The sample size was small.
  • Comparing antiemetics was difficult because the study did not use 5-HT3 antiemetics.
Print

Marx, W., McCarthy, A.L., Ried, K., McKavanagh, D., Vitetta, L., Sali, A., . . . Isenring, E. (2017). The effect of a standardized ginger extract on chemotherapy-induced nausea-related quality of life in patients undergoing moderately or highly emetogenic chemotherapy: A double blind, randomized, placebo controlled trial. Nutrients, 9, 867.

Study Purpose

To determine if the addition of a standard dose ginger supplement to a standard antiemetic protocol for moderately to highly emetogenic chemotherapy in patients who were chemotherapy naïve reduced the incidence of CINV and positively affected quality of life. Secondarily, to determine the effect on fatigue and malnutrition in these same study patients

Intervention Characteristics/Basic Study Process

The study group received 1.2 g of ginger extract in addition to standard unspecified antiemetics while the control group was given a placebo. The ginger or placebo was taken in divided doses four times per day for five days starting the day of chemotherapy and four days after for three cycles. Both the ginger and the placebo were in similar capsule forms.

Sample Characteristics

  • N = 34   
  • AGE: 57
  • MALES: 37%  
  • FEMALES: 63%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer, colon cancer, lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Moderately- and highly-emetogenic chemotherapy, Karnofsky score of 60, aged 18 years or older, no known coexisting disease process that causes nausea, and no use of over-the-counter drugs or complementary products.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Brisbane, Australia

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Double blinded, randomized, placebo controlled trial

Measurement Instruments/Methods

Functional Living Index Emesis 5 Day Recall (FLIE-5DR), Rhodes Inventory of Nausea, Vomiting, and Retching (INVR), Patient-Generated Subjective Global (FACT-G) assessed nutrition; Functional Assessment of Cancer Therapy-Global (FACT-G) assessed fatigue and QOL; Functional Assessment of Chronic Illness Therapy-Fatigue (FACTIT-F) and an assessment of factors that are known to increase the risk of CINV; symptom assessment using the Edmonton Symptom Assessment Scale to determine any adverse reactions to the ginger/placebo.

Results

The group receiving ginger had better nausea-related QOL and better total CINV-related QOL, less fatigue, and better overall cancer-related QOL, although clinical significance was minimal. There was no significant improvement in CINV occurrence or intensity.

Conclusions

Ginger had some benefits, including better nausea-related quality of life and better total CINV-related quality of life as well as less fatigue. The overall clinical significance of these findings is minimal. No significant improvement in CINV occurrence or intensity was noted.

Limitations

  • Small sample (< 100)
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: The group receiving ginger were able to guess they were receiving ginger due to the smell, taste, or reflux and lack of nausea.

Nursing Implications

There was no indication as to the cost or availability of this ginger extract, which may affect relevance. Also many assessment tools were used which questions validity. This manuscript suggests that ginger may be effective on nausea-related quality of life and fatigue, but a larger study would need to be done to confirm these findings.

Print

Panahi, Y., Saadat, A., Sahebkar, A., Hashemian, F., Taghikhani, M., & Abolhasani, E. (2012). Effect of ginger on acute and delayed chemotherapy-induced nausea and vomiting: A pilot, randomized, open-label clinical trial. Integrative Cancer Therapies, 11, 204-211.

Study Purpose

To evaluate the effects of ginger on acute and delayed chemotherapy-induced nausea and vomiting (CINV) in women being treated for breast cancer

Intervention Characteristics/Basic Study Process

Consecutive patients were alternatively assigned to the treatment or control group. Those in the treatment group were given 1.5 g ginger per day in addition to a standard antimetic regimen. The standard regimen consisted of graniestron plus dexamethasone. Treatment was given for four days.

Sample Characteristics

  • The study consisted of 78 patients.
  • The mean age of patients was not reported.
  • All of the patients were female.
  • All of the patients had been diagnosed with  breast cancer; the majority were receiving docetaxel, epirubicin, and cyclophosphamide.

Setting

The study was conducted at a single site in Iran.

Phase of Care and Clinical Applications

All patients were in active antitumor treatment.

Study Design

This was a randomized, open-label comparison.

Measurement Instruments/Methods

The Rhodes index of nausea, vomiting, and retching was used to measure CINV.

Results

The authors reported that patients in the treatment group had significantly less nausea in the first six hours of the study; however, no differences were found between groups at any other time point, and no differences were found between groups in terms of vomiting.

Conclusions

No significant differences were found between groups in CINV other than less nausea in the first six hours after chemotherapy with ginger.

Limitations

  • The sample size was small with fewer than 100 participants.
  • A risk of bias exists because no blinding or random assignment was used.
  • The measurement methods were not well described. The timing and exact use of CINV measurement was not described. 
  • The randomization of group assignment was questionable.
  • No demographic information was reported. Evaluation of demographic differences between the groups, which could have influenced CINV, was not included.
  • The authors suggested that ginger had positive effects, despite the lack of major significant findings, suggesting study bias. 
  • The study period was short.
  • Patient experience with previous chemotherapy courses or prior CINV was not reported.

Nursing Implications

These findings did not provide strong support for the efficacy of ginger in the management or prevention of acute or delayed CINV in patients receiving moderately emetogenic chemotherapy.

Print

Ryan, J.L., Heckler, C.E., Roscoe, J.A., Dakhil, S.R., Kirshner, J., Flynn, P.J., … Morrow, G.R. (2012). Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: A URCC CCOP study of 576 patients. Supportive Care in Cancer, 20, 1479-1489.

Study Purpose

To determine the dose and efficacy of ginger at reducing the severity of chemotherapy-induced nausea (CIN) on day one of chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to four arms.

  • Placebo
  • 0.5 g ginger
  • 1.0 g ginger
  • 1.5 g ginger

Nausea occurrence and severity were assessed at a baseline cycle and the two following cycles during which patients were taking their assigned study medication. All patients received a 5-HT3 receptor antagonist antiemetic on day one of all cycles. Patients took three capsules of ginger (250 mg) or placebo twice daily for six days starting three days before the first day of chemotherapy. Patients reported the severity of nausea for days 1–4 of each cycle, four times daily.  Compliance was determined by pill counts.

Sample Characteristics

  • The sample consisted of 576 patients.
  • Mean age was 53 years.
  • The sample was 91% female.
  • All participants had been diagnosed with cancer and were receiving chemotherapy.
  • All patients had to have experienced nausea in a previous chemotherapy cycle and be scheduled to receive a 5-HT3 plus dexamethasone for antiemetic management. 
  • Baseline values showed that more than 50% of the sample had had previous chemotherapy. Baseline nausea ranged from 2.2–2.5.

Setting

This was a multisite study conducted at 23 private practice oncology groups  affiliated with the University of Rochester.

Phase of Care and Clinical Applications

  • Patients were in mutliple phases of care.
  • Applications exist for palliative care.

Study Design

This was a phase II/III randomized, double blind, placebo-controlled clinical trial.

Measurement Instruments/Methods

  • Nausea and emesis were measured on a 7-point scale using a modified four-day patient report diary developed by Burish and Carey.
  • A 13-item Symptom Inventory was used to assess potential side effects of ginger, as well as anticipatory nausea, on an 11-point scale.
  • Anticipatory nausea was analyzed using the nausea item on the Symptom Inventory completed prior to chemotherapy.
  • Quality of life was assessed using the 27-item Functional Assessment of Chronic Illness Therapy-General (FACIT-G) at baseline and follow-up assessments .

Results

  • No significant differences were found between the treatment arms in regard to the use of antiemetics.
  • The mixed model analyses across both study cycles 2 and 3 revealed that all doses of ginger significantly reduced acute CIN in both study cycles compared to placebo (p = 0.013, 0.003). Differences in the least-squares means showed that 0.5 g and 1.0 g daily ginger were the most effective at reducing acute nausea.
  • Data suggested that patients reported more severe delayed nausea compared to acute nausea, and no differences were found between groups in delayed nausea.
  • Overall, no significant differences were observed in vomiting or quality of life between the three ginger arms and placebo.
  • The majority of patients did not report episodes of vomiting (mean incidence = 0.5). 
  • Analysis revealed that anticipatory nausea (p < 0.0001) was a factor in acute CIN.
  • A total of 24 adverse events were reported during the course of the study. Only nine of the reported adverse advents were considered to be related to study drug.

Conclusions

Ginger given at 0.5 g-1.0 g daily, may aid in the reduction of acute-phase CIN in patients receiving standard antiemetics. The ability to clearly interpret results is difficult because of lack of information on chemotherapy agents involved and differences in antiemetic regimens used.

Limitations

  • The chemotherapy agents used were not described, so the emetogenicity of the treatment or potential differences between groups, which could have affected results, are not known. 
  • No discussion was provided regarding use or non-use of rescue medications or any other management strategies that may have been used.
  • The antiemetic regimens used were varied, and it is known that different regimens have different levels of effect. 
  • Though inclusion criteria identified use of 5-HT3 medication, results reported show that four different types of regimens were actually employed.

Nursing Implications

This study showed that ginger significantly reduced nausea in these patients during the acute phase but had no apparent effect on delayed nausea. Studies in the use of ginger have had mixed results, and meta analysis have shown no effect, in contrast to this study. Here, only nausea was examined, which may partially explain differences. Application of these findings is difficult, because the chemotherapy regimens used are not described, so emetogenicity or differences in regimens between groups cannot be evaluated. Also, the antiemetic medications used were varied and subgroup analysis was not done; how this influenced findings is not clear. Even with maximum current pharmacologic management of chemotherapy-induced nausea and vomiting, control of nausea, as opposed to vomiting, has remained problematic. Further research in approaches to effectively manage nausea, as well as emesis is needed.

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Sanaati, F., Najafi, S., Kashaninia, Z., & Sadeghi, M. (2016). Effect of ginger and chamomile on nausea and vomiting caused by chemotherapy in Iranian women with breast cancer. Asian Pacific Journal of Cancer Prevention, 17, 4125–4129. 

Study Purpose

To determine the effect of ginger and chamomile capsules on chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

The ginger group received 500 mg capsules of ginger root twice a day for five days before and five days after chemotherapy, in addition to dexamethasone, metoclopramide, and aprepitant. The chamomile group received 500 mg capsules of Matricaria chamomilla extract twice daily five days before and five days after chemotherapy, in addition to dexamethasone, metoclopramide, and aprepitant. The control group received dexamethasone, metoclopramide, and aprepitant only. Participants used a visual analog scale (VAS) to record CINV and answered three questions about the use of other antiemetics, missed capsules, and side effects experienced. They filled out the questionnaires each night during the duration of the study.

Sample Characteristics

  • N = 65   
  • AGE = 20–60 years 
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Single-day chemotherapy, history of vomiting with previous chemotherapy

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Tehran, Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, double-blind clinical trial

Measurement Instruments/Methods

VAS for frequency and severity of nausea and vomiting

Results

Ginger and chamomile did not affect the intensity of nausea, whereas both had an effect on the frequency of vomiting (p < 0.0001). Ginger also was shown to be have a statistically significant effect on the frequency of nausea (p = 0.006). Neither had an effect on intensity of nausea.

Conclusions

Ginger and chamomile may have some benefit as adjuncts to antiemetics for the prevention of CINV. Additional research is needed to evaluate these.

Limitations

  • Small sample (< 100)
  • Findings not generalizable
  • Subject withdrawals ≥ 10%

Nursing Implications

Ginger may be beneficial in CINV, but ongoing studies are needed.

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Yekta, Z.P., Ebrahimi, S.M., Hosseini, M., Nasrabadi, A.N., Sedighi, S., Surmaghi, M.H., & Madani, H. (2012). Ginger as a miracle against chemotherapy-induced vomiting. Iranian Journal of Nursing and Midwifery Research, 17(5), 325–329.

Study Purpose

To evaluate the effect of the ginger plant on chemotherapy-induced vomiting

Intervention Characteristics/Basic Study Process

The intervention persisted for six days starting three days before the chemotherapy session. During this period, all participants took four 250 mg capsules (Zintoma) at six-hour intervals (1 g per day) complemented by the routine antiemetic regimen, including Kytril, or granisetron hydrochloride tablets, (1 mg per day) and dexamethasone ampoules (8 mg per day). A self-made, two-part, self-reporting instrument was used to measure the number of vomiting cases in both the groups. Vomiting times were recorded in the instruments each night just before sleep. 

Sample Characteristics

  • N = 80
  • AVERAGE AGE = (placebo group) 45.1 +/– 10 years; (intervention group) 41.8 +/– 8.4 years        
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Tehran, Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care

Study Design

Randomized, double-blind, placebo-controlled clinical trial

Measurement Instruments/Methods

A self-made, two-part, self-reporting instrument was used to measure the number of vomiting cases in both the groups. This instrument was a reliable standard table that has been used in various studies.

Results

Vomiting cases were meaningfully lower in the ginger group in the anticipatory (p = 0.04), acute (p = 0.04), and delayed (p = 0.003) phases, and after a total sum of six days (p = 0.002). The only stated side effect during the study was heartburn. However, there were no significant differences between the two groups at the anticipatory (p = 0.2), acute (p = 0.06), and delayed (p = 0.5) phases.

Conclusions

The results of this randomized, controlled trial showed that ginger alleviated nausea and vomiting in patients in the ginger arm compared to the placebo group. Ginger could be a promising antiemetic herbal remedy; however, its positive effects could be dose-related or specific agent-related. Therefore, we need further evidence, including multiagent chemotherapy with different types of cancers.

Limitations

  • The paper stated that participants received single-day chemotherapy. Although the prescribed antiemetics (e.g., Kytril,  Zofran, and dexamethasone) were clearly identified, this paper lacked information regarding the names of the chemotherapy agents. According to Table 1, the researchers considered chemotherapy agents to be low to moderately emetogenic, and refer the reader to check the American Society of Clinical Oncology's guidelines.
  • Small sample (< 100)
  • Key sample group differences that could influence results
  • Other limitations/explanation: This study was only done on women with breast cancer undergoing single-day courses of chemotherapy. Results were only connected with and applicable for patients with breast cancer and, consequently, cannot be generalized to other types of cancers.

Nursing Implications

The nursing implication was confined to teaching patients and their families about the ginger capsules.

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Zick, S.M., Ruffin, M.T., Lee, J., Normolle, D.P., Siden, R., Alrawi, S., & Brenner, D.E. (2009). Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Supportive Care in Cancer, 17, 563–572.

Study Purpose

To evaluate the efficacy of ginger in relief of delayed chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Patients with cancer who had experienced CINV during at least one previous round of chemotherapy were asked to participate. All participants were receiving a 5-HT3 receptor antagonist or aprepitant as part of their standard antiemetic regimen. Patients were randomized to receive either 1.0 g of ginger, 2.0 g of ginger, or matching placebo daily for three days.

Sample Characteristics

  • The study consisted of 162 participants.
  • The mean age was 55.7 years.
  • The majority of the participants was female.
  • Specific diagnoses were not stated.
  • Patients were receiving a variety of chemotherapy drugs of low, moderate, and high emetogenic risk.

Setting

The study was conducted at multiple outpatient settings in Ann Arbor, MI.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized double-blind, placebo-controlled trial.

Measurement Instruments/Methods

The Morrow Assessment of Nausea and Emesis (MANE) and the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 for Adverse Events were used.

Results

  • More than half (58%) of study participants reported experiencing both acute and delayed nausea; 30.9% reported acute vomiting or retching; and 24.7% reported delayed vomiting or retching.
  • No significant difference was found between either of the ginger doses compared to placebo in the terms of acute or delayed nausea or vomiting. This was consistent when participants were stratified by whether  aprepitant was prescribed as part of their CINV treatment.
  • Participants who received the higher dose of ginger (2.0 g) reported having significantly more severe episodes of delayed nausea compared to both placebo and low-dose ginger.

Conclusions

  • Ginger extract provided no benefit in reducing prevalence of delayed nausea and vomiting when added to standard contemporary antiemetic therapy.
  • When ginger was taken with aprepitant, prevalence of delayed vomiting was higher (although this did not reach statistical significance).

Limitations

  • The study lacked an adequate sample size.
  • Participants reported that they knew if they were randomized to either of the ginger treatment arms based on the taste of the capsule.

Nursing Implications

Ginger extract provides no clinical benefit at the doses evaluated when given in addition to standard, evidence-based medical therapy to prevent CINV. Ginger extract may have a negative effect on severity of nausea when taken with aprepitant.

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