Effectiveness Not Established

Carbamazepine

for Chemotherapy-Induced Nausea and Vomiting—Adult

Carbamazepine is used alone or with other medications in the treatment of certain types of seizures. Carbamazepine also is used to treat trigeminal neuralgia (a condition that causes facial nerve pain) and is an anticonvulsant that works by reducing abnormal electrical activity in the brain. Carbamazepine is available as a tablet, a chewable tablet, an extended-release tablet, an extended-release capsule, and a suspension (liquid) to take by mouth. Carbamazepine has been studied related to chemotherapy-induced nausea and vomiting (CINV) and peripheral neuropathy.

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682237.html

Research Evidence Summaries

Santana, T.A., Cruz, F.M., Trufelli, D.C., Glasberg, J., & Del Giglio, A. (2014). Carbamazepine for prevention of chemotherapy-induced nausea and vomiting: A pilot study. Sao Paulo Medical Journal, 132(3), 147–151. 

Study Purpose

The purpose of this study was to evaluate the potential effect of carbamazepine for chemotherapy-induced nausea and vomiting (CINV) for moderately or highly emetogenic chemotherapy (MEC or HEC). The secondary aim was to evaluate side effects of this treatment and its influence on quality of life.

Intervention Characteristics/Basic Study Process

The standard antiemetic regimen was given to all patients, which includes ondansetron IV 8 mg, dexamethasone IV 10 mg, and ranitidine IV 50 mg prior to chemotherapy (day 1). All patients also received dexamethasone PO 4 mg BID on days 2 and 3. In addition to the standard of care, all patients received carbamazepine 200 mg PO four times per day on the third day before chemotherapy, BID on the second day before chemotherapy, and three times a day on the day before chemotherapy. Patients continued taking carbamazepine 200 mg PO three times per day until the fifth day after chemotherapy. Patients recorded data on days 1–6. Rescue therapy was given as needed and included 5-HT3RA, phenothiazines, butyrophenones, and domperidone.

Sample Characteristics

  • N = 7  
  • AGE = 48 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer, highly emetogenic chemotherapy regimen
  • OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) score for all 10 women was 0, first cycle of chemotherapy

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient  
  • LOCATION: Brazil

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, descriptive study

Measurement Instruments/Methods

  • Functional Living Index-Emesis (FLIE) questionnaire
  • Patients recorded all episodes of vomiting on diary cards starting with chemotherapy and for six days after.  
  • Complete response was defined as the absence of any events of vomiting and no use of rescue medications.

Results

Ten patients signed informed consent, three subjects could not complete the study due to adverse events (two had vomiting prior to chemotherapy and one experienced severe somnolence). The remaining seven patients had no response to the treatment, and there was no documented impact on quality of life as measured by the FLIE. The study was therefore discontinued.

Conclusions

The study was closed after seven subjects completed the protocol without any positive response for CINV. Carbamazepine was not found to be effective for CINV in women treated with highly emetogenic chemotherapy and caused vomiting in 20% of patients prior to the induction of chemotherapy.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Subject withdrawals ≥ 10%

Nursing Implications

Because the study was closed due to a 0% efficacy for CINV in this small sample of women with breast cancer, carbamazepine should not be recommended for CINV treatment at this time.

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