Dexamethasone for Symptom Burden in Advanced Cancer Patients

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT00489307

Run by

M.D. Anderson Cancer Center

People needed

132

Starts

2006-02-02

Expected to finish

2028-02-28

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Memorial Delirium Assessment Scale (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.

You may not qualify if…

• 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 human immunodeficiency virus (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

Where it is running

• Lyndon Baines Johnson Hospital — Houston, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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