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


Phase 3
21 Years
N/A
Open (Enrolling)
Both
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Improvement of cancer-related fatigue as assessed by the Brief Fatigue Inventory total score at day 41 (after exercise intervention)

Outcome Time Frame:

7 weeks

Safety Issue:

No

Principal Investigator

Karen M. Mustian, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Federal Government

Study ID:

UCCO08106; URCC0701

NCT ID:

NCT00924651

Start Date:

September 2009

Completion Date:

November 2014

Related Keywords:

  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • fatigue
  • unspecified adult solid tumor, protocol specific
  • Fatigue

Name

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642