NCT00924651

Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy

A Study of the Effects of Exercise on Cancer-Related Fatigue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 693 (actual)
• Sponsor: Gary Morrow · Academic / Other
• Sex: All
• Age: 21 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. 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.

Conditions

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BEHAVIORAL	exercise	home based walking and progressive resistance training exercise

Timeline

• Start date: 2009-09-01
• Primary completion: 2016-02-01
• Completion: 2016-10-01
• First posted: 2009-06-19
• Last updated: 2017-08-08
• Results posted: 2017-08-08

Locations

1 site across 1 country: United States