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

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: IRG; National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ichthammol; Menthol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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