Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy (EXCAP)

Gary Morrow

Status

Completed

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Fatigue

Treatments

Behavioral: exercise

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00924651

UCCO-08106 (Other Identifier)

U10CA037420 (U.S. NIH Grant/Contract)

URCC 0701 (Other Grant/Funding Number)

UCCO08106 URCC0701;

Details and patient eligibility

About

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.

Full 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.

Enrollment

693 patients

Sex

All

Ages

21 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

primary diagnosis of cancer other than leukemia, with no distant metastasis
chemotherapy naïve
starting chemotherapy treatments for cancer and scheduled for at least 6 weeks of treatments with treatment cycles of either 2, 3 or 4 weeks. Oral chemotherapy (e.g., Xeloda) is acceptable
Karnofsky Performance level of 70 or greater
able to read English

Exclusion criteria

diagnosis of leukemia
metastatic disease
receiving concurrent radiation therapy
physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program
identified as in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form