Dexamethasone for Symptom Burden in Advanced Cancer Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: Dexamethasone Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| 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].
| Estimated Enrollment: | 160 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Dexamethasone |
Drug: Dexamethasone
4 mg PO (by mouth) twice daily x 14 days
Other Name: Decadron
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo PO twice daily x 14 days
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Present with 3 or more symptoms during the last 24 hours (Pain, fatigue, chronic nausea, and anorexia/cachexia, sleep problems, depression or poor appetite), with an average intensity of >/= 4 on a 0-10 scale, in which 0= no symptom, and 10= worst possible symptom,
- No clinical evidence of cognitive failure as evidenced by MDAS score of 13 or less at baseline
- Must be 18 years of older
- No longer a candidate for aggressive anticancer therapy-such as receptor blockers (Iressa, etc.) Patients on oral or palliative chemotherapy are eligible for study if approved by primary oncologist prior to inclusion. Patients who are receiving IV chemotherapy are eligible for study if approved by primary oncologist and they have completed 1st line of chemotherapy and are deemed stable by primary oncologist. The PI of this study will obtain and document approval from the primary oncologist in the patient's study documents.
- Life expectancy =/> 30 days
- Must understand and sign written informed consent
- Patients on topical, or inhaled corticosteroids are eligible for study. If patients have been on oral corticosteroids for </= 7 days prior to inclusion of study they are eligible for study.
Exclusion Criteria:
- Allergy to Dexamethasone
- Inability to complete the baseline assessment forms
- Patients currently taking Megestrol, and not off drug for > 7 days
- Anemia as defined as < 9 hemoglobin
- Known history of HIV
- Neutropenia as defined by an absolute neutrophil count (ANC) of < 1500 cells/mm
- Patients with a history of diabetes will be excluded.
- All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks
- Those who are currently receiving oral corticosteroid therapy or who have been on corticosteroid therapy >/= 8 days prior to study inclusion
- Sepsis and/or acute, chronic, or ongoing infections
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00489307 History of Changes |
| Other Study ID Numbers: | 2005-0816 |
| Study First Received: | June 19, 2007 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancer Solid Tumors Fatigue Pain Nausea |
Anorexia Dexamethasone Decadron Placebo |
Additional relevant MeSH terms:
|
Neoplasms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013