Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489307
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2007-06-19
Brief Title:
Dexamethasone for Symptom Burden in Advanced Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Effect of Dexamethasone on Symptoms in Patients With Advanced Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 dexamethasone can help to control symptoms such as fatigue pain nausea weight loss loss of appetite sleep problems andor depression in patients with advanced cancer
Detailed Description:
Dexamethasone decreases inflammation and also suppresses the immune system
If you are found to be eligible for this study you will be randomly assigned as in the toss of a coin to receive either dexamethasone or a placebo by mouth in the morning and at night with food every day for 14 days A placebo is a substance that looks like the study drug but which has no active ingredients You will have an equal chance of being placed in either of the 2 groups You the medical staff and researchers will not know to which group you have been assigned
Beginning on Day 15 3 days regardless of if you were assigned to the dexamethasone or placebo group during the first 14 days you will begin receiving the dexamethasone On Days 15-21 you will receive dexamethasone 2 times a day On Days 22-28 you will continue to take dexamethasone 2 times a day but it will be at a lower dose level
If you develop intolerable side effects while on this study the medication will be stopped and you will be removed from the study
You will be asked to return to the outpatient clinic on Days 8 3 days 15 3 days 22 3 days and 29 3 days to answer a questionnaire about your cancer diagnosis the medication you are taking and the symptoms you are having for example pain fatigue nausea appetite problems sleep problems depression and your overall sense of well-being The questionnaire will take approximately 30 minutes to complete Blood about 1 tablespoon will be drawn to measure protein levels and to check the iron level in your blood If you are unable to return to the clinic on days 8 15 22 or 29 the assessments will be done by the research nurse by phone the blood work will not be done
You will be considered off-study on Day 29 3 days All study patients will have a 2 week follow-up on day 43 3 days after study drug has been discontinued for safety and toxicity assessments If you are unable to return to the clinic on day 43 the research nurse will do the safety and toxicity assessment by phone
This is an investigational study Dexamethasone has been approved by the FDA and is a commercially available drug It is FDA approved at this dose level Its use in this study for this purpose is investigational About 160 patients will take part in this study Up to 110 will be enrolled at the University of Texas UT MD Anderson Cancer Center The other sites participating in this study are Lyndon Baines Johnson LBJ breast oncology clinic Houston Texas and Four Seasons Hospice in Flat Rock North Carolina
If you are found to be eligible for this study you will be randomly assigned as in the toss of a coin to receive either dexamethasone or a placebo by mouth in the morning and at night with food every day for 14 days A placebo is a substance that looks like the study drug but which has no active ingredients You will have an equal chance of being placed in either of the 2 groups You the medical staff and researchers will not know to which group you have been assigned
Beginning on Day 15 3 days regardless of if you were assigned to the dexamethasone or placebo group during the first 14 days you will begin receiving the dexamethasone On Days 15-21 you will receive dexamethasone 2 times a day On Days 22-28 you will continue to take dexamethasone 2 times a day but it will be at a lower dose level
If you develop intolerable side effects while on this study the medication will be stopped and you will be removed from the study
You will be asked to return to the outpatient clinic on Days 8 3 days 15 3 days 22 3 days and 29 3 days to answer a questionnaire about your cancer diagnosis the medication you are taking and the symptoms you are having for example pain fatigue nausea appetite problems sleep problems depression and your overall sense of well-being The questionnaire will take approximately 30 minutes to complete Blood about 1 tablespoon will be drawn to measure protein levels and to check the iron level in your blood If you are unable to return to the clinic on days 8 15 22 or 29 the assessments will be done by the research nurse by phone the blood work will not be done
You will be considered off-study on Day 29 3 days All study patients will have a 2 week follow-up on day 43 3 days after study drug has been discontinued for safety and toxicity assessments If you are unable to return to the clinic on day 43 the research nurse will do the safety and toxicity assessment by phone
This is an investigational study Dexamethasone has been approved by the FDA and is a commercially available drug It is FDA approved at this dose level Its use in this study for this purpose is investigational About 160 patients will take part in this study Up to 110 will be enrolled at the University of Texas UT MD Anderson Cancer Center The other sites participating in this study are Lyndon Baines Johnson LBJ breast oncology clinic Houston Texas and Four Seasons Hospice in Flat Rock North Carolina
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MRSG-07-001-01-CCE | OTHER_GRANT | American Cancer Society | None |
| NCI-2012-01646 | REGISTRY | None | None |