Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

693 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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

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Fatigue Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard Care + EXCAP

Personalized exercise prescription

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

home based walking and progressive resistance training exercise

Standard Care

Wait list control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise

home based walking and progressive resistance training exercise

Intervention Type BEHAVIORAL

Other Intervention Names

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EXCAP

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No