Fatigue Clinical Trial
Official title:
A Study of the Effects of Exercise on Cancer-Related Fatigue
RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving
chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise
program is effective in lessening fatigue.
PURPOSE: This randomized phase III trial is studying how well exercise works in lessening
fatigue caused by cancer in patients undergoing chemotherapy.
OBJECTIVES:
Primary
- Determine the efficacy of a home-based walking and progressive-resistance exercise
program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy.
Secondary
- Determine if a home-based walking and progressive-resistance exercise program can
improve aerobic capacity in these patients.
- Determine if a home-based walking and progressive-resistance exercise program can
improve strength in these patients.
- Determine if a home-based walking and progressive-resistance exercise program can
improve quality of life of these patients.
Supplemental
- To determine if a home-based walking and progressive resistance exercise program can
improve inflammatory profiles (IL-6, IL-8, IL-10, IL-1b, IFN-y, & TNFr1) among 300
patients receiving chemotherapy.
- To provide an initial examination of whether changes in IL-6, IL-8, IL-10, IL-1b,
IFN-y, & TNFr1 mediate the relationship between physical exercise and CRF.
- To determine if a home-based walking and progressive resistance exercise program can
increase total energy expenditure in kcal/kg/min assessed using actigraphy among 300
patients receiving chemotherapy.
- To determine if a home-based walking and progressive resistance exercise program can
increase two specific components of exercise dose: 1) duration of physical activity
measured in total minutes of non-sedentary activity, and 2) intensity of physical
activity measured in minutes of sedentary, low, moderate and vigorous activity using
objective actigraphy assessments.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue
reported on the study assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of
2 intervention arms.
- Arm I: Patients receive standard chemotherapy.
- Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer
Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo
moderately intense aerobic exercise (walking) monitored by a pedometer, and low to
moderately intense progressive-resistance exercise using therapeutic resistance bands
for 6 weeks. Patients also receive standard chemotherapy.
Patients in both arms undergo assessment of their aerobic capacity and strength by the
6-minute walk test and handgrip dynamometry at baseline and at day 41. They also have a
fasting blood draw and wear an actigraph for one week at baseline and week 6. Patients
complete Functional Assessment of Chronic Illness Therapy-Fatigue and -Cognitive Subscales,
Brief Fatigue Inventory, Multidimensional Fatigue Symptom Inventory, Center for
Epidemiological Studies-Depression Scale State Trait Anxiety Inventory, Pittsburgh Sleep
Quality Inventory, Profile of Mood States, Aerobic Center Longitudinal Study Physical
Activity, and Symptom Inventory questionnaires at baseline and at day 41 and keep a daily
exercise diary during study intervention.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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