Clinical trial NCT00553059
Conditions: Chemotherapy-induced Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific
Keywords: nausea and vomiting unspecified adult solid tumor Palonosetron Dexamethasone
Sponsor: M.D. Anderson Cancer Center
Start date: 2008-05-01; Completion date: 2014-08-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
The Study Drugs:

Dronabinol and palonosetron are both designed to help prevent nausea and vomiting in patients who are receiving chemotherapy.

Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

* If you are in Group 1, you will take dronabinol, dexamethasone, and palonosetron.
* If you are in Group 2, you will take a placebo, dexamethasone, and palonosetron. A placebo is a substance that looks like the study drug but has no active ingredients.

You will have an equal chance of being assigned to either group. Neither you nor your doctor can choose the group you will be in. During the study, you and the study staff will not know which group you are in. However, if needed for your safety, the study staff will be able to find out which group you are in.

After the last study participant completes their study therapy, you and the study staff will find out which group you were in.

Study Drug Administration:

On Day 1 (the day that you receive chemotherapy), you will take a dronabinol/placebo pill by mouth every 8 hours (if possible). If you cannot take the pill every 8 hours, you should try to space out the doses evenly. Your first dronabinol/placebo pill on Day 1 will be 30 minutes before chemotherapy.

You will also receive dexamethasone and palonosetron by vein 30 minutes before you receive chemotherapy.

On Days 2-6, you will take dronabinol/placebo 3 times a day. You should take each pill every 8 hours (if possible). If you cannot take them every 8 hours, you should try to space out the doses evenly.

Study Diary:

You will complete a study diary on Days 1-6. In this diary you will answer questions about nausea and vomiting.

Study Visits:

You will have a study visit on Day 8 and again sometime during Days 14-28. At both visits, you will be asked if you have experienced any side effects. You should return your study diary to the clinic at both visits. At the visit during Days 14-28, you will also have a physical exam.

Length of Study:

You will be on study for 30 days. You will be taken off study early if the nausea and vomiting do not improve or intolerable side effects occur.

This is an investigational study. Dronabinol and palonosetron are both FDA approved and commercially available to prevent nausea and vomiting that may occur from chemotherapy. Dexamethasone is FDA approved and commercially available for the prevention of side effects related to chemotherapy. The combination of these drugs to prevent nausea and vomiting is investigational.

Up to 200 patients will take part in this multicenter study. Up to 200 will be enrolled at M. D. Anderson.

Arms: arm 1: Palonosetron hydrochloride intravenous (IV) and dexamethasone IV 30 minutes before chemotherapy administration on day 1, and oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1. arm 2: Palonosetron hydrochloride and dexamethasone as in arm I, and oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.
Interventions: intervention 1: dexamethasone intervention 2: dronabinol intervention 3: palonosetron hydrochloride intervention 4: placebo
Intervention descriptions: intervention 1: 10 mg IV 30 minutes prior to administration of chemotherapy intervention 2: 5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy intervention 3: 0.25 mg IV 30 minutes prior to administration of chemotherapy intervention 4: 1 tablet by mouth three times a day beginning 30 minutes before chemotherapy

Protocol documents: