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

July 5, 2017 updated by: Gary Morrow

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
693

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standard Care + EXCAP
Personalized exercise prescription
Behavioral: exercise
home based walking and progressive resistance training exercise
Other Names:
  • EXCAP
No Intervention: Standard Care
Wait list control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)
Time Frame: 41 days: Day 0 (before intervention) Day 41 (post intervention)

BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).

The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention).
41 days: Day 0 (before intervention) Day 41 (post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gary Morrow

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen M. Mustian, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCCO08106; URCC0701
  • U10CA037420 (U.S. NIH Grant/Contract)
  • UCCO-08106 (Other Identifier: URCC)
  • URCC 0701 (Other Grant/Funding Number: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings