Dexamethasone for Symptom Burden in Advanced Cancer Patients
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, and/or depression in patients with advanced cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Dexamethasone on Symptoms in Patients With Advanced Cancer|
- Cancer-Related Fatigue [ Time Frame: Weekly ] [ Designated as safety issue: No ]Fatigue will be measured using the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F) on Days 8 [± 3 days], 15 [± 3 days] , 22 [± 3 days], and 29 [± 3 days].
|Study Start Date:||February 2006|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Dexamethasone||
4 mg PO (by mouth) twice daily x 14 days
Other Name: Decadron
|Placebo Comparator: Placebo||
Placebo PO twice daily x 14 days
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 M. D. Anderson. 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.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Lyndon Baines Johnson Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sriram Yennurajalingam, MD||M.D. Anderson Cancer Center|