Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-25 @ 4:17 AM
Study NCT ID:
NCT00553059
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2007-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: