Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy (EXCAP)
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Study of the Effects of Exercise on Cancer-Related Fatigue|
- Improvement of cancer-related fatigue as assessed by the Brief Fatigue Inventory total score at day 41 (after exercise intervention) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
- Improvement of aerobic capacity, strength, and quality of life as assessed by the 6-minute walk test, handgrip dynamometry, and Functional Assessment of Chronic Illness Therapy-Fatigue total score at day 41 (after exercise intervention) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Standard Care + EXCAP
Personalized exercise prescription
home based walking and progressive resistance training exercise
Other Name: EXCAP
No Intervention: Standard Care
Wait list control
- Determine the efficacy of a home-based walking and progressive-resistance exercise program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924651
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Karen M. Mustian, PhD||University of Rochester|