Pectasides, D., Dafni, U., Aravantinos, G., Timotheadou, E., Skarlos, D.V., Pavlidis, N., … Fountzilas, G. (2007). A randomized trial to compare the efficacy and safety of antiemetic treatment with ondansetron and ondansetron zydis in patients with breast cancer treated with high-dose epirubicin. Anticancer Research, 27(6C), 4411–4417.
Study Purpose
To compare oral ondansetron to oral dissolving tablet (ODT) ondansetron at the same dose (8 mg twice daily for three days)
Sample Characteristics
- The study consisted of 134 patients with breast cancer receiving their first dose of highly emetogenic chemotherapy.
- The ODT arm had 66 participants, and the oral arm had 68 participants.
Study Design
This was a phase II, randomized trial.
Measurement Instruments/Methods
- Patients used diaries to record emesis and nausea episodes.
- Intensity of nausea was measured with a four-point Likert-type scale.
Results
- The ODT arm was associated with inferior emesis control (52% for ODT versus 72% for oral arm, p = 0.020).
- More patients in the ODT arm required rescue medication.
- Patients in the ODT arm had significantly higher nausea intensity (p = 0.036).