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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00924651
First received: June 18, 2009
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: exercise
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 692
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Care + EXCAP
Personalized exercise prescription
Behavioral: exercise
home based walking and progressive resistance training exercise
Other Name: EXCAP
No Intervention: Standard Care
Wait list control

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924651

Locations
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
Gary Morrow
Investigators
Principal Investigator: Karen M. Mustian, PhD University of Rochester
  More Information

Additional Information:
No publications provided

Responsible Party: Gary Morrow, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00924651     History of Changes
Other Study ID Numbers: UCCO08106; URCC0701, U10CA037420, UCCO-08106, URCC 0701
Study First Received: June 18, 2009
Last Updated: August 2, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
fatigue
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014