Dexamethasone for Symptom Burden in Advanced Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00489307
First received: June 19, 2007
Last updated: May 22, 2013
Last verified: May 2013

June 19, 2007
May 22, 2013
February 2006
February 2015   (final data collection date for primary outcome measure)
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].
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Complete list of historical versions of study NCT00489307 on ClinicalTrials.gov Archive Site
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Dexamethasone for Symptom Burden in Advanced Cancer Patients
The Effect of Dexamethasone on Symptoms in Patients With Advanced Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Solid Tumors
  • Drug: Dexamethasone
    4 mg PO (by mouth) twice daily x 14 days
    Other Name: Decadron
  • Drug: Placebo
    Placebo PO twice daily x 14 days
  • Active Comparator: Dexamethasone
    Dexamethasone 4 mg orally two times a day for 14 days. On day 15 [ ± 3 days], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone will be tapered to 2 mg orally twice a day between days 22 to 28.
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Placebo

    Placebo by mouth (PO) twice daily x 14 days.

    On day 15 [ ± 3 days], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone will be tapered to 2 mg orally twice a day between days 22 to 28.

    Interventions:
    • Drug: Dexamethasone
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
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February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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,
  2. No clinical evidence of cognitive failure as evidenced by MDAS score of 13 or less at baseline
  3. Must be 18 years of older
  4. 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.
  5. Life expectancy =/> 30 days
  6. Must understand and sign written informed consent
  7. 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:

  1. Allergy to Dexamethasone
  2. Inability to complete the baseline assessment forms
  3. Patients currently taking Megestrol, and not off drug for > 7 days
  4. Anemia as defined as < 9 hemoglobin
  5. Known history of HIV
  6. Neutropenia as defined by an absolute neutrophil count (ANC) of < 1500 cells/mm
  7. Patients with a history of diabetes will be excluded.
  8. All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks
  9. Those who are currently receiving oral corticosteroid therapy or who have been on corticosteroid therapy >/= 8 days prior to study inclusion
  10. Sepsis and/or acute, chronic, or ongoing infections
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00489307
2005-0816
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Sriram Yennurajalingam, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP