Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01952886|
Recruitment Status : Withdrawn (Lack of approval and funding from company)
First Posted : September 30, 2013
Last Update Posted : September 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Drug: Granisetron Drug: Ondansetron||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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)|
|Actual Primary Completion Date :||September 2014|
Experimental: Granisetron patch
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.
Other Name: Kytril
Active Comparator: Ondansetron tablet
Ondansetron 8 mg oral tablet is prescribed for once a day.
Other Name: Zofran, Zuplenz
- Satisfaction with Granisetron Transdermal Delivery System (GTDS) versus Ondansetron pill [ Time Frame: first 2 weeks after starting study ]The percentage of subjects who prefer GTDS over Ondansetron pills as determined by the response to the question "Which nausea medication was I most satisfied with?"
- Complete response (CR) rate of Granisetron Transdermal Delivery System (GTDS) compared to Ondansetron pill [ Time Frame: first 2 weeks after starting study ]A comparison of the CR rate associated with GTDS and that associated with ondansetron. The CR rate is defined as the proportion of subjects with no emetic episode or use of rescue medication while receiving study medication, radiation and concomitant temozolomide during weeks 1 and 2.
- Subject Compliance with Granisetron Transdermal Delivery System (GTDS) and Ondansetron pills [ Time Frame: 2 weeks ]The compliance rate will be measured as the percentage of days that GTDS or ondansetron pill were used during weeks 1 and 2 according to medication instructions
- Number of subjects experiencing a grade ≥3 treatment-related toxicity [ Time Frame: 2 weeks ]The number of subjects experiencing a grade ≥3 treatment-related toxicity during weeks 1 and 2. Adverse events will be assessed using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
- Patient satisfaction from the Treatment Satisfaction Questionnaire for Medication (TSQM-9 ) [ Time Frame: 2 weeks ]A patient satisfaction score will be computed based upon responses to the TSQM-9. The score will be based on perceived effectiveness, convenience, and global satisfaction. Scores are 0-100, with higher scores indicating higher satisfaction. Subjects complete this questionnaire after patch and pill treatment at the end of weeks 1 and 2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952886
|United States, North Carolina|
|Duke Cancer Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Mary Lou Affronti, DNP, MSN, MHSc||Duke University|