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Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer

NCT00553059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-10-09

Study results available
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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.

Conditions

  • Chemotherapy-induced Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

dexamethasone

10 mg IV 30 minutes prior to administration of chemotherapy

DRUG

dronabinol

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

DRUG

palonosetron hydrochloride

0.25 mg IV 30 minutes prior to administration of chemotherapy

OTHER

placebo

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Steven M. Grunberg, MD · University of Vermont

  • Amal I. Melhem-Bertrandt, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00553059 on ClinicalTrials.gov