Physical Activity With or Without Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Locally Advanced, Metastatic, or Recurrent Cancer

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

Conditions studied: Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm

In brief

This phase II/III trial studies how well physical activity with or without dexamethasone works in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body or has come back. Dexamethasone may decrease the body's immune response. Combining physical activity with dexamethasone may help to treat fatigue in patients with cancer.

Key facts

Study ID

NCT03583255

Run by

M.D. Anderson Cancer Center

People needed

99

Starts

2018-06-29

Expected to finish

2027-12-31

Last updated by the study team

2026-07-09

Who can join

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

You may qualify if…

• Diagnosis of locally advanced cancer (defined as metastatic or recurrent cancer or completed 2 lines of therapy) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
• Presence of fatigue for at least 2 weeks
• Normal cognition defined as Memorial Delirium Assessment Scale (MDAS) of =< 13/30 completed in person or via video conference
• Hemoglobin > 8 g/L within 2 weeks of enrollment in the study
• Zubrod performance status =< 2
• Life expectancy of >= 4 months
• Able to read, write, and speak English

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 of 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
• 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
• Symptomatic cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
• Patients currently on immunotherapy
• Inability to comply with study protocol procedures

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.