Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess patient satisfaction, the efficacy and compliance of
granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in
malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant
temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing
compliance.
All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY
of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized
to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will
received the other medication. The granisetron transdermal delivery system (supplied as a 52
cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours
before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken
once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out
questionnaires regarding the effectiveness of the medication and their satisfaction, and
which anti-emetic they prefer.
Safety will be assessed throughout the six weeks of radiation by the clinical research nurse
using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who
receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be
included in analyses of treatment preference. However, all other efficacy and safety analyses
will include all subjects who received ondansetron or GTDS.