Ahvazi, N.C., Hemati, S., & Mohamadianpanah, M. (2015). Effect of increase in duration of aprepitant consumption from 3 to 6 days on the prevention of nausea and vomiting in women receiving combination of anthracycline/cyclophosphamide chemotherapy: A randomized, crossover, clinical trial. Advanced Biomedical Research, 4, 238–9175.168605. eCollection 2015. 

DOI Link

Study Purpose

To evaluate the effect of an increased duration of aprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Women scheduled to receive AC regimens (doxorubicin and cyclophosphamide) enrolled in the study were randomly assigned to two groups. One group received a three-day aprepitant regimen in the first course of chemotherapy and six days in the second course. The other group received six days of aprepitant in the first course and three days in the second course of chemotherapy. All patients also received 8 mg dexamethasone IV on day 1 followed by 80 mg dexamethasone daily. During the six day course, dexamethasone was given for six days, and on the three-day regimen, it was given for three days. A 30-day washout existed between courses. Study measures were done at baseline for both chemotherapy cycles and seven days later.

Sample Characteristics

  • N = 49
  • MEAN AGE = 38.7 years (SD = 6.5)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: No indication of patients being chemotherapy naive

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized, controlled, crossover trial

Measurement Instruments/Methods

  • Eastern Cooperative Oncology Group (ECOG) toxicity questionnaire 
  • Complete response (CR) defined as no nausea and no episodes of vomiting

Results

Sixty-three percent had CR with the six-day regimen compared to 39% with the three-day regimen (p < 0.001). The order of treatment regimens did not affect results.

Conclusions

The use of aprepitant and dexamethasone for six days was more effective than a three-day regimen for the prevention of CINV.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • The ECOG questions for nausea have questionable validity for symptom measurement.
  • No 5-HT3 was administered, which is recommended for AC regimens.

Nursing Implications

Findings suggest that the provision of an antiemetic regimen for a longer duration in patients receiving highly emetogenic chemotherapy may be more beneficial to prevent CINV than current three-day regimens. Further well designed research in this area would be helpful.