Physical Activity With or Without Dexamethasone in Reducing Cancer-Related Fatigue in Patients Wi… (NCT03583255) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Physical Activity With or Without Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Locally Advanced, Metastatic, or Recurrent Cancer
United States99 participantsStarted 2018-06-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prot…
What they're measuring
1
Feasibility For Participants with Cancer-Related Fatigue (CRF)