Bechtel, T., McBride, A., Crawford, B., Bullington, S., Hofmeister, C.C., Benson Jr, D.M., . . . Devine, S.M. (2014). Aprepitant for the control of delayed nausea and vomiting associated with the use of high-dose melphalan for autologous peripheral blood stem cell transplants in patients with multiple myeloma: A phase II study. Supportive Care in Cancer, 22, 2911–2916. 

DOI Link

Study Purpose

To evaluate the efficacy of adding aprepitant to an antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Participants received aprepitant at 125 mg orally on day 1 followed by 80 mg orally at 24 and 48 hours after the initial dose of aprepitant. Ondansetron was given at 16 mg orally on day 1, and dexamethasone was given at at 12 mg orally on day 1 and at 8 mg orally on days 2–4. Breakthrough medications were used as needed. There was no comparison or control group. To evaluate nausea and vomiting, patients were assessed four to six times per day for the presence or absence of vomiting, the frequency of emetic episodes, the need for breakthrough antiemetic medication, and a nausea score provided by the nurse. Mean nausea scores were assessed every 24 hours beginning 24 hours after chemotherapy and continuing 120 hours after chemotherapy.

Sample Characteristics

  • N = 26  
  • MEAN AGE = 59.3 years (no range given)
  • MALES: 65%, FEMALES: 35%
  • KEY DISEASE CHARACTERISTICS: Multiple myeloma and autologous stem cell transplant
  • OTHER KEY SAMPLE CHARACTERISTICS: High-dose melphalan

Setting

  • SITE: Not specified
  • SETTING TYPE: Not specified    
  • LOCATION: Not specified

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, single-arm study

Measurement Instruments/Methods

  • Nausea scores were determined using a linear analog scale (0–10).

Results

Complete response was defined as no more than one emetic episode during the evaluation period. Of the 26 participants, 25 (96%) completely responded and needed no additional breakthrough medication. Twenty-four (92%) had no documented emetic episodes during the study period. Some degree of nausea was reported by 23 out of 26 (88%) patients, and the mean nausea score for the entire group during the study period was 0.7 (range = 0–10).

Conclusions

Adding aprepitant to a standard antiemetic regimen may result in lower rates of CINV associated with high-dose melphalan and stem cell transplant.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)

 

Nursing Implications

Adding aprepitant to standard antiemetic regimens may result in better controlled CINV. However, with such a small sample size and no comparison group, attributing these results to the intervention is difficult.