Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Advanced Malignant Neoplasm, Fatigue, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm

In brief

This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.

Key facts

Study ID

NCT02491632

Run by

M.D. Anderson Cancer Center

People needed

90

Starts

2015-08-13

Expected to finish

2026-12-31

Last updated by the study team

2026-03-18

Who can join

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

You may qualify if…

• A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
• The presence of fatigue for at least 2 weeks
• Normal cognition
• Hemoglobin > 8 g/L within 1 week of enrollment in the study
• A life expectancy of >= 4 months
• No evidence of significant anxiety or depression as determined by a total HADS scores of < 21
• Definition of advanced cancer includes those patients who have metastatic or refractory disease according to their treating oncologist
• Patients must be able to understand, read, write, and speak English or Spanish

You may not qualify if…

• Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician
• Reports a fall in the past 30 days
• Uncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physician
• Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
• Will exclude patients with current, active peptic ulcer disease
• Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm
• Regular participation in moderate- or vigorous-intensity physical activity for >= 30 minutes at least 5 times a week and strength training for >= 2 days
• Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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