Badar, T., Cortes, J., Borthakur, G., O'Brien, S., Wierda, W., Garcia-Manero, G., . . . Mattiuzzi, G. (2015). Phase II, open label, randomized comparative trial of ondansetron alone versus the combination of ondansetron and aprepitant for the prevention of nausea and vomiting in patients with hematologic malignancies receiving regimens containing high-dose cytarabine. BioMed Research International, 2015, 497597. 

DOI Link

Study Purpose

To compare the effectiveness of antiemetic regimens including ondansetron with and without aprepitant to prevent chemotherpy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Patients were randomized to receive (a) an antiemetic regimen consisting of ondansetron 8 mg IV 30 minutes before chemotherapy followed by 24 mg IV in a continuous infusion daily till 6–12 hours after the last dose of chemotherapy or (b) the same ondansetron regimen with the addition of oral aprepitant 125 mg 6–12 hours before chemotherapy and 80 mg daily till one day after the last dose of chemotherapy. Data were collected for six days following chemotherapy administration.

Sample Characteristics

  • N = 83
  • AVERAGE AGE = 51 years
  • MALES: 56%, FEMALES: 44%
  • KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, high-risk myelodysplastic syndrome, or chronic myeloid leukemia in blast phase
  • OTHER KEY SAMPLE CHARACTERISTICS: Receiving cytarabine-based chemotherapy at a dose ≥ 1 g/m2 per day for at least three days

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Not well described
  • Daily diary to record episodes of nausea or vomiting and any rescue medications needed

Results

There were no statistically significant differences in the prevention of CINV or use of rescue medications between the two arms.

Conclusions

There was no difference in CINV prevention between antiemetic regimens of ondansetron with or without aprepitant.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable

 

Nursing Implications

There was no significant difference between antiemetic regimens of ondansetron with or without aprepitant in the prevention of CINV. There may not be a benefit to adding aprepitant to standard antiemetic therapy in this population of patients.