Study to Compare the Safety and Efficacy of 2 Different Doses of Inhaled D8-THC to Standard Therapy With Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy
The study is comparing the use of inhaled delata-8-THC in the prevention of nausea and
vomitting in patients being treated with moderately emetogenic chemotherapy, and the
patients will continue use for 3 days afterward. Patients will be given rescue medication
and will fill out VAS scales for nausea, pain, appetite and dizziness. Patients will be
treated for 2 cycles, one cycle receiving active drug (one of 2 doses) and the other
placebo. Patients receiving placebo will receive ondansetron injection before chemo and
patients receiving active drug will receive a normal saline injection. Patients will take
the drug 4 times daily for 3 days. The patients will return to clinic for a visit after
24-48 hours and 4 days. Patients will bring a urine sample to measure metabolite. Patients
will be given a diary to monitor dosing and side effects as well as concomitant medication.
The study will be conducted in 2 - 3 centers. There will be 108 patients enrolled with 27
in each of 4 groups:
Group 1 cycle 1 - Placebo cycle 2 - 300 mcg of delta-8-THC per dose Group 2 cycle 1 -
Placebo cycle 2 - 600 mcg of delta-8-THC per dose Group 3 cycle 1 - 300 mcg of delta-8-THC
per doseGroup cycle 2 - Placebo Group 4 cycle 1 - 600 mcg of delta-8-THC per dose cycle 2 -
placebo
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
VAS scale for nausea
Nathan Cherny, MD
Principal Investigator
Shaare Zedek Medical Center, Dept. of Oncology
Israel: Israeli Health Ministry Pharmaceutical Administration
Rafa protocol THC002/NVP
NCT00285051
November 2005
November 2005
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