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

PRIMARY OBJECTIVES:

I. To test the hypotheses that patients with cancer-related fatigue (CRF) will be satisfied with the physical activity + dexamethasone (PA+ DEX) intervention, have adequate rates of adherence, and that PA+ DEX will be feasible for patients with CRF.

Ia. To determine if the combination of PA+ DEX is a feasible intervention for advanced cancer patients, as evidenced by an adherence rate to daily use of PA+ DEX greater than or equal to 75%.

Ib. To determine if patients are satisfied with PA+ DEX, based on more than 75% of patients indicating their satisfaction with PA+ DEX with a rating of "somewhat satisfied" or "completely satisfied."

SECONDARY OBJECTIVES:

I. To test the hypothesis that PA+ DEX (PA for 4 weeks plus dexamethasone 4 mg twice a day for 1 week) will be more efficacious than PA+ placebo (PA for 4 weeks plus placebo for 1 week) on CRF as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).

Ia. To determine if PA+ DEX results in robust reduction in FACIT-F subscale scores (defined as >= 10 point improvement in 60% of patients).

II. To explore the effects of PA+ DEX on fatigue-related symptoms and function. IIa. To determine if PA+ DEX improves CRF by targeting the various associated factors of CRF.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive dexamethasone orally (PO) twice daily (BID) for 7 days. Patients also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.

ARM II: Patients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.

After completion of study, patients are followed up at 29 days and 1 month.

Inclusion criteria

• 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

Exclusion criteria

• 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