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Knols, R., Aaronson, N. K., Uebelhart, D., Fransen, J., & Aufdemkampe, G. (2005). Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. Journal of Clinical Oncology, 23, 3830–3842.

Search Strategy

Databases searched were MEDLINE, CINAHL, Cochrane Library, CANCERLIT, and PEDro through June 2004 to identify randomized, controlled trials and controlled trials (those with a comparison group but without explicit use of randomization for purposes of group allocation).

To be included in the review, the trials had to have examined the effects of physical exercise after surgery or during or after chemotherapy, radiotherapy, and/or hormonal therapy. Only exercise interventions designed to improve endurance or muscular strength were included.

Studies of relaxing exercises (e.g., yoga or tai-chi) were excluded.

Literature Evaluated

The methodologic quality (using the Delphi criteria list—a set of nine criteria for quality assessment of clinical trials) and substantive results of 34 randomized, controlled trials and controlled trials was examined. Of the 34 studies examined, 22 examined the effectiveness of physical exercise during medical treatment, whereas 12 focused on the period after medical treatment.

Outcomes were fatigue, health-related quality of life, symptom distress, psychological distress, body composition, physical exercise capacity (maximal oxygen consumption [VO2] max), self-reported exercise/physical activity level, and other physical performance measures, such as walk time. Various physical exercise modalities were used, differing in type (walking, cycling, swimming, resistive exercises, or combined exercises), intensity (with most programs at 50% to 90% of the estimated VO2 maximum heart rate), frequency (ranging from two times per week to up to two times daily), and duration (ranging from two weeks up to one year). In some studies, the experimental group was compared with a group that received some form of training of a lesser intensity, frequency, and/or duration (e.g., stretching, self-directed exercises, strength exercises, aerobic exercise of a lesser intensity, swimming, behavioral therapy). In other studies, the comparison group did not receive any exercise program or advice, was on a waiting list, or participated in a cross-over trial.

Sample Characteristics

The studies during medical treatment were divided into three subcategories: (1) exercise during breast cancer treatment, (2) exercise during bone marrow and peripheral blood stem cell transplantation, and (3) exercise during medical treatment for mixed solid tumors. The studies after medical treatment were divided into those involving exercise after breast cancer treatment and exercise after medical treatment for other solid tumors. The authors used this strategy to reflect not only differences in cancer diagnosis and the timing of physical exercise programs, but also possible differences in motivation, safety, feasibility and efficacy of exercise. The sample sizes for the intervention groups ranged from 12 to 188 participants.

Results

A clinically significant or statistically significant positive effect of physical activity specifically on fatigue was noted during breast cancer treatment  (three studies) or after breast cancer treatment (two studies), and during treatment (three studies) or after treatment (one study) in a mixed solid tumor population. The median quality criteria score on the Delphi list (range 1–7) was four for studies of exercise during and after cancer treatment. Twenty-five of the trials satisfied more than three criteria on the Delphi criteria list. The most commonly observed methodologic problems were with concealment of treatment allocation, blinding of the outcome assessor, and failure to use an intention-to-treat data analysis strategy.

Conclusions

Overall, the authors concluded that the included trials were of moderate methodologic quality, with a trend toward more methodologic rigor in more recent studies.

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Knijn N., Tol, J., Koopman, M., Werter M.J., Imholz, A.L., Valster, F.A., . . . Punt C.J. (2011). The effect of prophylactic calcium and magnesium infusions on the incidence of neurotoxicity and clinical outcome of oxaliplatin-based systemic treatment in advanced colorectal cancer patients. European Journal of Cancer, 47, 369–374.

Study Purpose

The purpose was to assess the effect of calcium and magnesium infusions on incidence of neurotoxicity and clinical outcomes in patients treated in a phase III trial (CAIRO2) with oxaliplatin-based chemotherapy.

Intervention Characteristics/Basic Study Process

Patients who had been treated in an randomized clinical trial for advanced colorectal cancer with either capecitabine, oxaliplatin, and bevacizumab or the same regimen with the addition of cetuximab were retrospectively divided into two groups: those who had received calcium and magnesium infusion at least during the first oxaliplatin cycle and those who did not receive calcium and magnesium during cycle 1. To evaluate the impact on prevention, incidence of neurotoxicity was defined as early (occurring during the first six cycles) or late (present at the last cycle).

Sample Characteristics

  • A total sample of 732 participants with colon cancer were enrolled, with men (60%) outnumbering women (40%).
  • The mean age of participants was 61.9 years with a range of 27–83 years.

Setting

The study was conducted in multiple outpatient facilities in Norway.

Phase of Care and Clinical Applications

  • Active treatment
  • Late effects

Study Design

The study was a retrospective analysis of trial data.

Measurement Instruments/Methods

  • The National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0.
  • An evaluation of tumor response with the Response Evaluation Criteria in Solid Tumors (RECIST).

Results

Sample sizes were varied between groups, with 551 having received calcium and magnesium and 181 who did not. Incidence of any grade neurotoxicity was 85% in those who received calcium and magnesium and 92% in those who did not (p = 0.02), and incidence of grade 2 or higher was not significantly different between groups. Early neurotoxicity of any grade occurred more often in those who did not receive calcium and magnesium (91% versus 81%, p = 0.0002). In addition, no significant difference were noted between groups in incidence of grade 2 or higher early toxicity. All grade late neurotoxicity was lower in those who were in the calcium and magnesium group; however, incidence of grade 2or higher late toxicity was no different between groups. No difference was noted in survival or response rates between study groups.

Conclusions

Findings suggest that calcium and magnesium infusion may be helpful in the prevention of neurotoxicity with oxaliplatin; however, findings do not show a clear difference in more severe toxicity of grade 2 or higher.

Limitations

  • Limitations include the retrospective nature of the study with no appropriate control in place.
  • The authors define the calcium and magnesium group as getting this infusion with the first cycle of chemotherapy; however, whether or not any of these patients or other patients got any such infusions with later cycles is unclear.
  • The only outcome measure is the toxicity grading scale.
  • No information is provided regarding total cumulative chemotherapy doses (whether any cycles were not provided, etc.) to evaluate any differences in symptoms according to chemotherapy dosage and cycle completions.

Nursing Implications

The findings suggest the potential effect of calcium and magnesium infusions in the prevention of neurotoxicity; however, the findings do not show any difference in terms of prevalence of higher grade neurotoxicity. Additional research in this area is needed with more definitive outcome measures.

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Kmetec, A., & Hajdinjak, T. (2013). Evaluation of safety and analgesic consumption in patients with advanced cancer treated with zoledronic acid. Radiology and Oncology, 47, 289–295.

Study Purpose

To evaluate zoledronic acid treatment in patients with advanced cancer and metastases to bone, in regards to safety and effectiveness (as measured by serum value of calcium, concurrent analgesic use, reported bone pain, and pathological bone fractures)

Intervention Characteristics/Basic Study Process

An observational clinical study was conducted that monitored patients with cancer receiving monthly zoledronic acid treatment for 12 months. At each visit, pain status was evaluated using a visual analog scale (VAS), as well as by monitoring prescribed analgesics. Lab values were obtained, and skeletal events (pathological bone fractures, spinal cord compression, or concurrent therapy to palliate bone lesions) were recorded. Monthly doses of zoledronic acid were prescribed and infused according to each disease’s treatment guidelines.

Sample Characteristics

  • N = 125  
  • AGE RANGE = 47–89 years
  • MEAN AGE = 69.2 years
  • MALES: 86%, FEMALES: 14%
  • KEY DISEASE CHARACTERISTICS: 73.6% had prostate cancer, and 22.4% were diagnosed with multiple myeloma.
  • OTHER KEY SAMPLE CHARACTERISTICS: Primarily prescribed for prevention of skeletal events

Setting

  • SITE: Mulit-site
  • SETTING TYPE: Outpatient 
  • LOCATION: Slovenia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Palliative, end-of-life care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • This was an observational, 12-month, multi-center study that monitored patients monthly for 12 months.

Measurement Instruments/Methods

At each monthly visit, measurements were taken as follows.

  • Analgesic consumption measured and recorded by type prescribed
  • Pain status measured on VAS
  • Lab values including serum creatinine, calcium, hemoglobin, albumin, alkaline phosphatase, bilirubin, aspartame aminotransferase, alanine aminotransferase, and prostate-specific antigen in patients with prostate cancer
  • Skeletal-related events

Results

The percentage of patients on analgesics decreased in the multiple myeloma group from 57%–24%. In the group with prostate cancer, this percentage increased from 70%–88%. Pain VAS scores decreased by 22% in the patients with prostate cancer and by 97% in those with multiple myeloma. Hypocalcemia was recorded in 4% of all participants. Thirty-one skeletal events were reported by 10 patients (rate of 8%).

Conclusions

Zoledronic acid as treatment for patients with multiple myeloma may account for diminished concurrent use of analgesics for the same group over the annual period observed. Patients receiving zoledronic acid treatment concurrently with analgesics experienced a reduction in all types of skeletal events. This does appear to be an effective treatment for patients diagnosed with prostate cancer, specifically in terms of prophylactic treatment with bone metastases, as it has shown a decrease in skeletal events and pathological fractures. It is not effective for palliation of pain symptoms for patients with pancreatic cancer, as analgesic use increased for this group of patients.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no appropriate attentional control condition)
  • Excluded patients receiving any cancer therapy other than painkillers

Nursing Implications

Nurses work with patients to identify and communicate concerns to treatment providers at the earliest possible onset. The results of this study indicate a need for nurses to continue to evaluate, educate, and assist patients to communicate concerns to providers for the purpose of pursuing earliest possible interventions that provide the maximum effectiveness and best possible outcome for quality of care provided and quality of life resulting from that care for each patient. These findings reiterate an area for nursing attention when evaluating patients with pain issues at all stages of disease from initial diagnosis to progression, end-stage, and palliative care.

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Kloke, M., Cherny, N., & ESMO Guidelines Committee. (2015). Treatment of dyspnoea in advanced cancer patients: ESMO Clinical Practice Guidelines. Annals of Oncology, 26(Suppl. 5), v169–v173. 

Purpose & Patient Population

PURPOSE: To provide recommendations for the management of dyspnea in patients with advanced cancer
 
TYPES OF PATIENTS ADDRESSED: Advanced cancer

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Consensus-based guideline

PROCESS OF DEVELOPMENT: Relevant literature was selected by the authors; not based on a systematic review

Phase of Care and Clinical Applications

PHASE OF CARE: End of life/palliative care
 
APPLICATIONS: Palliative care 

Results Provided in the Reference

Not specified

Guidelines & Recommendations

  • Oxygen is not recommended for routine use. It can alleviate dyspnea in patients with hypoxia.
  • Opioids are identified as the only pharmacologic agents with sufficient evidence for effectiveness.
  • Benzodiazepines can be used in cases of insufficient response to opioids, either alone or in combination with opioids.
  • Little evidence for nonpharmacologic interventions exists.
  • In assessment, it is important to differentiate between continuous, episodic, breakthrough, or crisis breathlessness and determine exacerbating and relieving factors.
  • Treatment of reversible causes should be considered before starting symptomatic treatment.

Limitations

  • No specified systematic review
  • Written as mainly consensus-based

Nursing Implications

Provides very basic recommendations for dyspnea management in patients with advanced disease.

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Kligler, B., Homel, P., Harrison, L. B., Sackett, E., Levenson, H., Kenney, J., . . . Merrell, W. (2011). Impact of the Urban Zen Initiative on patients' experience of admission to an inpatient oncology floor: a mixed-methods analysis. Journal of Alternative and Complementary Medicine, 17, 729–734.

Study Purpose

To evaluate the impact of the Urban Zen Initiative (UZI) on quantitative and qualitative measures of the experiences of patients admitted for inpatient oncology care.

Intervention Characteristics/Basic Study Process

The UZI model consists of five focus points:  the physical space surrounding patients, holistic nursing techniques, yoga with trained therapists, a navigator for patients, and audiovisual yoga materials at the bedside. All patients received the intervention; therefore, the investigators collected preintervention information about patients who were receiving standard care prior to the UZI intervention. Preintervention data were the basis of the control comparison. The investigators measured the outcomes immediately after admission and immediately before discharge. 

Sample Characteristics

  • The sample was comprised of 163 patients.
  • Mean age preintervention was 52.9 years (standard deviation [SD] = 17.3 years). Mean age in the UZI group was 54.4 years (SD = 14.6 years).
  • The preintervention group was comprised of 55% males and 45% females. The UZI group was comprised of 49% males and 51% females.
  • The investigators did not specify the key disease characteristics.
  • Patients were included if they
    • Were admitted to a specific inpatient oncology unit
    • Had a Karnofsky Performance Status (KPS) score greater than 60
    • Had a life expectancy longer than six months
    • Were able to speak English.

Setting

  • Single site
  • Inpatient
  • Beth Israel Deaconess Medical Center, New York City

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a quasiexperimental design with historical control groups.

Measurement Instruments/Methods

  • Profile of Mood States–Brief Form (POMS-BF)    
  • EuroQol EQ-5D
  • Semistructured qualitative interview
     

Results

  • The investigators noted no significant admission or discharge changes based on POMS scores.
  • The investigators reported significant changes between groups in regard to tension (p = 0.009), depression (p = 0.03), vigor (p = 0.001), fatigue (p = 0.03), and total mood disturbance (p = 0.008). The scores indicated positive associations with UZI.
  • Mobility was significantly different (p = 0.03) between the groups, according to the EQ-5D scores. The EQ-5D demonstrated no significant group-based changes in pain, anxiety, or health state.
  • Thirty-three patients participated in qualitative data collection and indicated that the experience included fear and the need for information, caring, and connection. Responses also described the impact of the physical environment on patients' experiences, as well as the impact of yoga on patients' experiences of symptoms. Some patients stated they believed that what they had learned from the UZI could be useful in the future.

Conclusions

UZI may improve components of mood in an inpatient oncology setting. More work is needed to assess the real impact.

Limitations

  • The study had a risk of bias due to lacking an appropriate historical control group.
  • Knowing which part of the intervention had the greatest effect was difficult because the UZI has many components.
  • Whether the finding of significant pre- and post-UZI differences was based on initial POMS scores or \"change scores\" is unclear. Based on change scores, no intergroup differences existed.  

Nursing Implications

Providing a multifaceted healing environment, such as the UZI, within inpatient oncology settings could improve mood and perceived health status in patients with cancer. To facilitate the care process, nurses should assess patients' physical spaces; promote relaxation techniques, such as yoga breathing; and support patients.

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Klemm, P. (2012). Effects of online support group format (moderated vs peer-led) on depressive symptoms and extent of participation in women with breast cancer. Computers, Informatics, Nursing: CIN, 30(1), 9–18.

Study Purpose

To evaluate the effects, in women with breast cancer, of moderated and peer-led online support group format on symptoms of depression and degree of participation

Intervention Characteristics/Basic Study Process

Investigator distributed recruitment material via postal mail, online, or through nonprofit organizations or the media. Interested women contacted the investigator after receiving or seeing recruitment material. Participants were placed into a moderated or peer-led group, in groups of 15 according to time of recruitment. All online support was accessed via a university-owned web page devoted to the work. Participants could not access groups to which they were not assigned. Moderators were master's-prepared social workers with experience with online and telephone help for people with cancer and their caregivers. Investigators obtained study measures at baseline and at 6, 12, and 16 weeks. The group was maintained for 12 weeks.

Sample Characteristics

  • The sample was composed of 50 participants.
  • Mean patient age was 52.22 years, and the age range was 28–77 years.
  • All participants were female.
  • All participants had breast cancer and were to have completed treatment within the 32 days prior to inclusion.
  • Most participants were married and white, and they reported an income above $50,000 annually. Most had stage I or II cancer and had received multimodal therapy. Of all participants, 96% were not taking any antidepressant.
     

Setting

  • Single site
  • Home 
  • Newark, Delaware, United States
     

Phase of Care and Clinical Applications

  • Phases of care: multiple
  • Clinical applications: late effects and survivorship

 

Study Design

Longitudinal two-group design

Measurement Instruments/Methods

Center for Epidemiological Studies Depression Scale (CESD)

Results

At the end of the study, findings revealed no significant effects, on symptoms of depression, in regard to group, time, or time by group format. CESD scores in peer-led groups declined slightly at all study time points but were not significantly different from the scores of moderator-led groups. In both groups, symptoms of depression were mild. More messages were posted and read in moderated groups than in peer-led groups.

Conclusions

The study showed no effect of peer- or moderator-led online support groups on symptoms of depression in women with breast cancer.

Limitations

  • The study had a small sample size, with fewer than 100 participants.
  • The study had risks of bias due to no blinding and the characteristics of the sample.
  • The CESD was not sensitive enough to pick up significant changes, and the study was probably underpowered.
  • The sample was self-selected, and participants tended to be affluent. Results would not necessarily be applicable to other groups. 
  • Women with higher depression scores were in the peer-led group. Overall, all participants had low depression scores.
     

Nursing Implications

This study does not provide strong support for the effectiveness of either peer-led or moderated online support groups on symptoms of depression; however, at baseline the depression scores of most participants were fairly low, and study groups were not balanced on baseline depression symptoms. It is not clear if such support efforts are beneficial to individuals who do not have a high level of depression symptoms. This finding could have influenced study results. Research in this area should stratify samples on the basis of the level of symptoms at baseline.

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Klein, P.J., Schneider, R., & Rhoads, C.J. (2016). Qigong in cancer care: A systematic review and construct analysis of effective Qigong therapy. Supportive Care in Cancer, 24, 3209–3222. 

Purpose

STUDY PURPOSE: To assess the strength of evidence addressing qigong therapy in supportive cancer care and describe the definition of effective qigong therapy in supportive cancer care

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed and EBSCO with the terms cancer, qigong, tai chi, and filters clinical research, humans, and years (January 2000–June 2015)
 
INCLUSION CRITERIA: Randomized, controlled trials; individuals with cancer; internal qigong or tai chi performed as qigong therapy
 
EXCLUSION CRITERIA: Pilot and exploratory studies, operationally defined studies with less than 15 participants per group, studies that did not have English full text

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 27 retrieved, 11 met inclusion and exclusion criteria.
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Consensus agreement between two researchers

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 11
  • TOTAL PATIENTS INCLUDED IN REVIEW = 831 patients
  • SAMPLE RANGE ACROSS STUDIES: 32–162 patients
  • KEY SAMPLE CHARACTERISTICS: Wide variety of geographic regions; heterogeneous populations, of which 50% had breast cancer; wide variations in time of interventions from early treatment to recovery; patients receiving multiple treatment modalities

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Results

For the purpose of the reviewer’s comments, results were limited to the primary symptom of fatigue and two common concurrent symptoms, depression and fatigue. Five of the 11 studies included fatigue as an outcome measure. Measures improved significantly in groups using some form of qigong or tai chi intervention in four studies and showed no difference in the fifth study. Mixed benefits on depression were reported. No significant differences in sleep were reported. Constructs of qigong therapy were identified as slow, gentle, repetitious, flowing, weight-bearing movements, breath regulation, mindfulness, meditation, energy cultivation, and relaxation.

Conclusions

The authors reported growing research evidence that the practice of qigong has benefits for managing fatigue and improving quality of life in individuals with cancer. However, outcomes on mediation of inflammation/immune support, depression, anxiety, stress, mood, sleep, systolic blood pressure, and survival rate were reported as mixed, and, as only 4 or the 11 studies included samples from the U.S. (N = 389 of 831 participants included in the review [47%]), the validity of the conclusion is questionable for a broader to application to general supportive care across all populations with cancer.

Limitations

  • Limited search
  • Limited number of studies included
  • Mostly low quality/high risk of bias studies
  • High heterogeneity
  • Low sample sizes
  • The technique requires expert skills to train participants
  • Limited access to qigong expertise in U.S.
  • Variations in constructs for qigong and limited descriptions of techniques of qigong intervention reported in studies

Nursing Implications

Logically consistent operational and conceptual definitions of qigong are needed for future research. Additional evidence is needed prior to recommending qigong to be integrated into cancer care. Access to trained qigong practitioners is needed for application to research across broad populations of patients with cancer.

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Klein, J., & Griffiths, P. (2004). Acupressure for nausea and vomiting in cancer patients receiving chemotherapy. British Journal of Community Nursing, 9, 383-387.

Search Strategy

Databases searched were MEDLINE, Embase, AMED, the Cochrane Database, Cancerlit, and CINAHL.

Search keywords were adult patients receiving chemotherapy, with nausea and vomiting duration or intensity measured as outcomes.

Literature Evaluated

Two randomized controlled trials were identified involving 482 patients. The studies compared acupressure to no intervention control. However, the second study did not meet inclusion criteria, as transcutaneous electrical nerve stimulation (TENS) of antiemetic point was used.

Nursing Implications

Results suggested that acupressure may decrease nausea in patients receiving chemotherapy, but further work is required before conclusively advising patients on the efficacy of acupressure in preventing and treating chemotherapy-induced nausea and vomiting (CINV).

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Klair, J.S., Girotra, M., Hutchins, L.F., Caradine, K.D., Aduli, F., & Garcia-Saenz-de-Sicilia, M. (2016). Ipilimumab-induced gastrointestinal toxicities: A management algorithm. Digestive Diseases and Sciences, 61, 2132–2139. 

Purpose & Patient Population

PURPOSE: To provide awareness to gastroenterologists regarding the wide spectrum of gastrointestinal toxicity of ipilimumab
 
TYPES OF PATIENTS ADDRESSED: Patients with recurrent or malignant melanoma

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Expert opinion

INCLUSION CRITERIA: Ipilimumab, colitis, perforation, metastatic melanoma

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment 
 
APPLICATIONS: Elder care

Results Provided in the Reference

The authors developed an algorithm for caring for patients who develop diarrhea with ipilimumab treatment. Three case studies were outlined. In one study, a patient developed autoimmune colitis after an infectious diarrhea workup was negative, was treated with high-dose glucocorticoids, and improved. Another patient presented with bloody diarrhea, leukocytosis, negative stool cultures, and negative C-difficile. A colonoscopy showed severe active colitis with ulcerations that were inflammatory based on biopsy and pathology. The patient was treated with infliximab and improved. The third patient presented with nausea/vomiting, and diarrhea for one week, had negative stool and C-difficile cultures, no leukocytosis, and a normal erythrocyte sedimentation rate. Autoimmune colitis was noted on a sigmoidoscopy. The patient improved with glucocorticoids.

Guidelines & Recommendations

1. Infectious diarrhea workup with onset of diarrhea during ipilimumab with consideration that diarrhea is ipilimumab induced until proven otherwise
 
2. Grade 1–2 diarrhea: Hold ipilumumab and manage symptoms with hydration, electrolyte replacement, and antidiarrheals. If the patient improves, consider restarting ipilimumab. If not, start a steroid taper. If symptoms persist on steroids, consider lower endoscopy.
 
3. Grade 3–4 diarrhea: Admit patient to hospital and consider ICU. Serial abdominal exams and surgical consult should take place for possible acute abdomen or perforation. Perform symptom management of diarrhea. Use antibiotics if suspicious of sepsis/perforation. Urgent lower endoscopy. Use high-dose IV steroids followed by oral steroid taper over six to eight weeks. Follow up three days after steroid induction. If symptoms havenot improved, start infliximab. Permanently stop ipilimumab.

Limitations

Case study of three patients, each with a different presentation. Two of the patients were octogenarians, and both developed more severe symptoms than the third patient, who was 51 years. Patient comorbidities were not identified.

Nursing Implications

Nurses need to carefully assess gastrointestinal symptoms in patients receiving ipilimumab to minimize complications.

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Kitazaki, T., Fukuda, Y., Fukahori, S., Oyanagi, K., Soda, H., Nakamura, Y., & Kohno, S. (2015). Usefulness of antiemetic therapy with aprepitant, palonosetron, and dexamethasone for lung cancer patients on cisplatin-based or carboplatin-based chemotherapy. Supportive Care in Cancer, 23, 185–190.

Study Purpose

To evaluate the effectiveness of a combination of aprepitant, palonosetron, and dexamethasone during the acute and delayed phase of chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer receiving carboplatin-based, moderately emetogenic chemotherapy or cisplatin-based, highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

133 patients with lung cancer receiving carboplatin-based or cisplatin-based chemotherapy from September 2010 until December 2011
 
Patients receiving carboplatin-based chemotherapy received the following prophylactic antiemetics.
  • Day 1: Aprepitant 125 mg PO, palonosetron 0.75 mg IV, and dexamethasone 3.3 mg IV
  • Days 2 and 3: Aprepitant 80 mg PO
 
Patients receiving cisplatin-based chemotherapy received the following prophylactic antiemetics.
  • Day 1: Aprepitant 125 mg PO, palonosetron 0.75 mg IV, and dexamethasone 9.9 mg IV
  • Days 2 and 3: Aprepitant 80 mg PO and dexamethasone 3.3 mg IV
 
The patients completed questionnaires on self-reported nausea and vomiting on days 1–5. The percentage of patients with a complete response (no nausea and no use of rescues medications) was the primary endpoint.

Sample Characteristics

  • N = 133 courses
  • MEAN AGE = 65.8 years
  • MALES: 77%, FEMALES: 23%
  • KEY DISEASE CHARACTERISTICS: Lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Prior experiences of CINV and motion sickness and a history of alcohol consumption

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified    
  • LOCATION: Department of Respiratory Medicine at Sasebo City General Hospital in Japan

Phase of Care and Clinical Applications

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

Study Design

This study was a prospective trial.

Measurement Instruments/Methods

  • Patients completed a self-reported questionnaire on the presence of emesis (yes or no), level of nausea (four choices), and status of salvage treatment. This questionnaire was completed on days 1–5.

Results

Complete response (CR) was defined as the absence of nausea with no salvage treatment required. From days 1–5, 86% of patients receiving carboplatin-based chemotherapy achieved CR (95%, CI: 78–93), and 71% of patients receiving cisplatin-based chemotherapy achieved CR (95%, CI: 58–84). In the acute phase, patients receiving carboplatin-based chemotherapy and patients receiving cisplatin-based chemotherapy had similar CR rates (98% versus 100%). In the delayed phase (days 2–5), 87% of patients receiving carboplatin-based chemotherapy achieved CR (95%, CI: 94–100), and 71% of patients receiving cisplatin-based chemotherapy achieved CR (95%, CI: 58–84).
 
For patients receiving carboplatin-based chemotherapy or cisplatin-based chemotherapy, there were no significant differences in gender, age, prior experience of emesis after chemotherapy, history of alcohol intake, or prior experience of motion sickness. 

Conclusions

Patients who received carboplatin or cisplatin-based chemotherapy had CINV, even with prophylaxis including aprepitant, palonosetron, and dexamethasone. There was no difference in CINV rates between patients who received carboplatin and those who received cisplatin-based chemotherapy. This study did not compare this regimen to any other prophylaxis, so it is difficult to draw a conclusion regarding the usefulness of this regimen for CINV prophylaxis for moderately or highly emetogenic chemotherapy.

Limitations

  • Risk of bias (no control group)
  • Findings not generalizable
  • Other limitations/explanation: This study only included patients with lung cancer who received carboplatin- or cisplatin-based chemotherapy. The prospective study included only one facility. The findings of this study may not be generalizable.

Nursing Implications

This article provides information on CINV for patients with lung cancer receiving carboplatin- or cisplatin-based chemotherapy who have taken prophylactic aprepitant, palonosetron, and dexamethasone. This information may help inform nurses providing patient education about acute and delayed CINV in this population. 
 
The use of a combination of aprepitant, palonosetron, and dexamethasone as prophylactic treatment for CINV was effective for the majority of patients with lung cancer receiving carboplatin- and cisplatin-based protocols in this study in the acute, delayed, and overall phases after chemotherapy administration.
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