NCT01952886

Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients

Phase II Randomized Cross-over Study to Evaluate Patient Satisfaction, Efficacy and Compliance of Granisetron Patch vs. Ondansetron in Malignant Glioma Patients Receiving Standard Radiotherapy (RT) and Concomitant Temozolomide (TMZ)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to assess whether malignant glioma patients receiving radiation therapy and concomitant TMZ are more satisfied with ondansetron or granisetron patch for the prevention of nausea and vomiting. The secondary objectives are 1) to compare the efficacy and compliance of granisetron patch and ondansetron in the prevention of nausea and vomiting during the 6 weeks of RT and concomitant TMZ, and 2) to assess the safety of the granisetron patch in preventing radiation induced nausea and vomiting in primary glioma patients receiving RT and TMZ. All eligible subjects should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of temozolomide daily for a total of six weeks. Subjects will be randomized to receive one of two treatment sequences of antiemetic therapy for the prevention of nausea and vomiting associated with RT and concomitant TMZ. Sequence #1 involves administration of ondansetron for 3 weeks followed by the use of granisetron patch for 3 weeks; whereas sequence #2 involves the use of the granisetron patch for 3 weeks followed by 3 weeks of ondansetron. Toxicity will be assessed each week of radiation therapy based on the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The subject will be asked to complete the modified MASCC Antiemesis Tool (MAT) questionnaire at baseline, and on days 2, 4, and 7 of each week of radiation therapy, as well as to record the use of all study medication and any antiemetic rescue medication taken daily. At the end of the weeks 3 \& 6, the subject will be asked to fill out a Treatment Satisfaction Questionnaire for Medication and will be asked at the end of week 6 to choose which antiemetic they prefer.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
DRUG	Granisetron
DRUG	Ondansetron

Timeline

• Primary completion: 2014-09-01
• First posted: 2013-09-30
• Last updated: 2014-09-22

Locations

1 site across 1 country: United States