Trial record 1 of 1 for:    URCC 08106
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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

June 18, 2009
August 2, 2014
September 2009
December 2014   (final data collection date for primary outcome measure)
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 ]
Improvement of cancer-related fatigue as assessed by the Brief Fatigue Inventory total score at day 41 (after exercise intervention) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00924651 on ClinicalTrials.gov Archive Site
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 ]
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) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
A Study of the Effects of Exercise on Cancer-Related Fatigue

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: exercise
home based walking and progressive resistance training exercise
Other Name: EXCAP
  • Experimental: Standard Care + EXCAP
    Personalized exercise prescription
    Intervention: Behavioral: exercise
  • No Intervention: Standard Care
    Wait list control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
692
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00924651
UCCO08106; URCC0701, U10CA037420, UCCO-08106, URCC 0701
Yes
Gary Morrow, University of Rochester
Gary Morrow
National Cancer Institute (NCI)
Principal Investigator: Karen M. Mustian, PhD University of Rochester
University of Rochester
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP