Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy

Fatigue Clinical Trial

— EXCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924651
• Other study ID #: UCCO08106; URCC0701
• Secondary ID: U10CA037420UCCO-
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2009
• Last updated: January 4, 2017
• Start date: September 2009
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: October 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Behavioral:
• exercise
home based walking and progressive resistance training exercise

Locations

Country	Name	City	State
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of cancer-related fatigue as assessed by the Brief Fatigue Inventory total score at day 41 (after exercise intervention)		7 weeks	No
Secondary	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)		7 weeks	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database