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.

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

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.

• 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

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

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

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

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).

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.

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

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

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