CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
dexamethasone +3 moredrug
Likely dose
dexamethasone 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00553059
NCT00553059Phase 3Completed
CompareCT.gov

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

M.D. Anderson Cancer Center·interventional·Posted Nov 5, 2007·Updated Oct 9, 2020

In Brief

A Phase 3 clinical trial evaluating dexamethasone, dronabinol, and 2 other interventions for Chemotherapy-induced Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 62 participants across 4 sites.

Detailed Summary

The goal of this clinical research study is to learn if adding dronabinol in combination with the standard of care (dexamethasone and palonosetron) can better help to control nausea and vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-induced Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Solvay Pharmaceuticals

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 5, 2007
Enrollment StartMay 1, 2008
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 18.7 years ago

Interventions

dexamethasonedrug

10 mg IV 30 minutes prior to administration of chemotherapy

dronabinoldrug

5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy

palonosetron hydrochloridedrug

0.25 mg IV 30 minutes prior to administration of chemotherapy

placeboother

1 tablet by mouth three times a day beginning 30 minutes before chemotherapy