Back to results

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

Primary Purpose

Malignant Glioma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Granisetron

Ondansetron

About this trial

This is an interventional supportive care trial for Malignant Glioma focused on measuring malignant glioma, antiemetic, ondansetron, granisetron, Preston Robert Tisch Brain Tumor Center, Pro00041233, Duke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have histologically confirmed diagnosis of malignant glioma (Glioblastoma, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) who may or may not be chemotherapy naïve and who are scheduled to receive radiotherapy (for a total of 60 GY) and concomitant daily temozolomide therapy (at a dose of 75 mg/m2 for one complete six week cycle).
Age ≥ 18 years
Karnofsky ≥ 60%
Hematocrit > 29%, ANC >1,000 cells/mm3, platelets > 100,000 cells/ mm3
Serum creatinine < 1.4 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal
For patients on corticosteroids, they must have been on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible
Ability and willingness to give informed consent
If sexually active, patients will take contraceptive measures for the duration of the treatments
Negative serum pregnancy test 48 hours prior to beginning study drug

Exclusion Criteria:

Pregnancy or breastfeeding
Co-medication that may interfere with study results; e.g., immune-suppressive agents other than corticosteroids
Inability or unwillingness to cooperate with the study procedures
Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of radiation therapy through the full course of radiation therapy is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Rescue medication for treatment of nausea and vomiting is permitted after radiation therapy at the discretion of the investigator
Previous participation in any clinical trial involving granisetron
Any vomiting, retching, or NCI Common Toxicity Criteria version 4.0 grade 2-4 nausea in the 24 hours preceding radiation and chemotherapy
Ongoing vomiting from any organic etiology
Radiotherapy of abdomen within one week prior to or during the study
Received granisetron within 14 days prior to study enrollment
Prior and concomitant cancer chemotherapy and radiotherapy

Sites / Locations

Duke Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Granisetron patch

Ondansetron tablet

Arm Description

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.

Ondansetron 8 mg oral tablet is prescribed for once a day.

Outcomes

Primary Outcome Measures

Satisfaction with Granisetron Transdermal Delivery System (GTDS) versus Ondansetron pill

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?"

Secondary Outcome Measures

Complete response (CR) rate of Granisetron Transdermal Delivery System (GTDS) compared to Ondansetron pill

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

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

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 )

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.

Full Information

NCT ID

NCT01952886

First Posted

September 25, 2013

Last Updated

September 19, 2014

Sponsor

Duke University

Collaborators

Prostrakan Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01952886

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of approval and funding from company

Study Start Date

undefined (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Prostrakan Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Glioma

Keywords

malignant glioma, antiemetic, ondansetron, granisetron, Preston Robert Tisch Brain Tumor Center, Pro00041233, Duke

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Granisetron patch

Arm Type

Experimental

Arm Description

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.

Arm Title

Ondansetron tablet

Arm Type

Active Comparator

Arm Description

Ondansetron 8 mg oral tablet is prescribed for once a day.

Intervention Type

Drug

Intervention Name(s)

Granisetron

Other Intervention Name(s)

Kytril

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Other Intervention Name(s)

Zofran, Zuplenz

Primary Outcome Measure Information:

Title

Satisfaction with Granisetron Transdermal Delivery System (GTDS) versus Ondansetron pill

Description

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?"

Time Frame

first 2 weeks after starting study

Secondary Outcome Measure Information:

Title

Complete response (CR) rate of Granisetron Transdermal Delivery System (GTDS) compared to Ondansetron pill

Description

Time Frame

first 2 weeks after starting study

Title

Subject Compliance with Granisetron Transdermal Delivery System (GTDS) and Ondansetron pills

Description

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

Time Frame

2 weeks

Title

Number of subjects experiencing a grade ≥3 treatment-related toxicity

Description

Time Frame

2 weeks

Title

Patient satisfaction from the Treatment Satisfaction Questionnaire for Medication (TSQM-9 )

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically confirmed diagnosis of malignant glioma (Glioblastoma, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) who may or may not be chemotherapy naïve and who are scheduled to receive radiotherapy (for a total of 60 GY) and concomitant daily temozolomide therapy (at a dose of 75 mg/m2 for one complete six week cycle). Age ≥ 18 years Karnofsky ≥ 60% Hematocrit > 29%, ANC >1,000 cells/mm3, platelets > 100,000 cells/ mm3 Serum creatinine < 1.4 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal For patients on corticosteroids, they must have been on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible Ability and willingness to give informed consent If sexually active, patients will take contraceptive measures for the duration of the treatments Negative serum pregnancy test 48 hours prior to beginning study drug Exclusion Criteria: Pregnancy or breastfeeding Co-medication that may interfere with study results; e.g., immune-suppressive agents other than corticosteroids Inability or unwillingness to cooperate with the study procedures Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of radiation therapy through the full course of radiation therapy is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Rescue medication for treatment of nausea and vomiting is permitted after radiation therapy at the discretion of the investigator Previous participation in any clinical trial involving granisetron Any vomiting, retching, or NCI Common Toxicity Criteria version 4.0 grade 2-4 nausea in the 24 hours preceding radiation and chemotherapy Ongoing vomiting from any organic etiology Radiotherapy of abdomen within one week prior to or during the study Received granisetron within 14 days prior to study enrollment Prior and concomitant cancer chemotherapy and radiotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Lou Affronti, DNP, MSN, MHSc

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.cancer.duke.edu/btc/

Description

The Preston Robert Tisch Brain Tumor Center at Duke

Learn more about this trial

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

We'll reach out to this number within 24 hrs