Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/Dexamethasone With or Without Dronabinol for the Prevention of Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy
- To determine whether dronabinol can add significantly to the antiemetic protection
provided by a standard palonosetron hydrochloride and dexamethasone regimen for
patients receiving moderately emetogenic chemotherapy.
- To determine the tolerability of dronabinol when added to a regimen of dexamethasone
and palonosetron hydrochloride administered for the prevention of acute and delayed
nausea and vomiting caused by moderately emetogenic chemotherapy.
- To determine tolerability, in terms of treatment-limiting toxicities, observed with the
OUTLINE: This is a multicenter study. Patients are stratified according to study center.
Patients receive scheduled chemotherapy (cyclophosphamide and/or doxorubicin hydrochloride)
beginning on day 1. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive palonosetron hydrochloride intravenous (IV) and dexamethasone
IV 30 minutes before chemotherapy administration on day 1. Patients also receive oral
dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy
administration on day 1.
- Arm II: Patients receive palonosetron hydrochloride and dexamethasone as in arm I.
Patients also receive an oral placebo 3 times a day for 5 days beginning 30 minutes
before chemotherapy on day 1.
In both arms, treatment continues in the absence of nausea or vomiting within 24 hours after
initiation of chemotherapy.
Patients complete a Daily Assessment of Nausea and Vomiting questionnaire after the
administration of chemotherapy on days 1-5.
Patients are followed at the completion of course 1 of chemotherapy (days 14-28).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Number of Participants with Total protection
Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire during the overall [0-120 hour] period.
5 Days (first 5 days of the first cycle of chemotherapy)
Steven M. Grunberg, MD
University of Vermont
United States: Federal Government
|Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Greenville||Greenville, South Carolina 29615|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|
|University of Texas M.D. Anderson CCOP Research Base||Houston, Texas 77030-4009|