Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

September 2, 2022 updated by: Hackensack Meridian Health

Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer

Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer related fatigue (CRF) is a common and debilitating side effect of radiotherapy in breast cancer patients. Physical activity interventions can attenuate CRF. The proposed study is a randomized, controlled trial (RCT) of exercise of structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce CRF and improve health-related quality of life among breast cancer patients. Eighty women with breast cancer scheduled to receive radiation therapy at Hackensack University Medical Center (HUMC) will be randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; or 2) a control group. Intervention arm participants will exercise at the hospital either before or after their radiation treatment. Assessments will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit. The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life (QOL). The study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing CRF in women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • 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 Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University 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

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. women between the ages of 18 and 75 years
  2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
  3. radiation therapy naïve
  4. sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire
  5. ambulatory
  6. negative serum pregnancy test and not planning to become pregnant in the next three months
  7. able to provide meaningful consent.
  8. Patients must have been deemed by their medical oncologist or internist that they "may participate in [this] exercise trial." Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program.

Exclusion Criteria:

  1. younger than 18 or older than 75 years
  2. no histological confirmation of breast cancer
  3. prior breast, chest, or pelvic radiotherapy
  4. concurrent chemotherapy
  5. distant metastases
  6. physical limitations that contraindicate participation in low to moderate intensity exercise
  7. positive pregnancy test
  8. currently engaged in moderate to vigorous physical activity
  9. psychiatric disorder which would render the participant unable to provide informed consent.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Moderate Exercise
Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).
Other: Moderate Exercise
Aerobic training utilizing the portable stationary pedal exerciser (Pedlar) which contains two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. Participants are required to perform 15 minutes/day of aerobic exercise using the Pedlar device on radiation treatment days; during a standard radiation course, this will typically yield 75 minutes/week of aerobic time.
NO_INTERVENTION: Control Group
No exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change in fatigue via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) survey instrument.
Time Frame: Baseline, 4 weeks into RT, 4 week follow up visit
The FACIT is a 13-item subscale developed to identify a finite set of concerns specific to fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 4-point likert scale, with score ranging from 0 to 52. The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability.
Baseline, 4 weeks into RT, 4 week follow up visit
Assessment of change in blood biomarker of inflammation: High sensitivity CRP (hsCRP)
Time Frame: Baseline, 4 weeks into RT, 4 week follow up visit
Serum hsCRP will be measured on the Vitros 5,1 FS Chemistry platform via an immunoassay with a reportable range of 0.10 -15.00 mg/L, and intra- and inter-assay CVs of 1.8-4.0%.
Baseline, 4 weeks into RT, 4 week follow up visit
Assessment of change in blood biomarker of inflammation: Serum fibrinogen
Time Frame: Baseline, 4 weeks into RT, 4 week follow up visit
Fibrinogen will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%.
Baseline, 4 weeks into RT, 4 week follow up visit
Assessment of change in blood biomarker of inflammation: Ferritin
Time Frame: Baseline, 4 weeks into RT, 4 week follow up visit
Ferritin will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%.
Baseline, 4 weeks into RT, 4 week follow up visit
Complete blood count data (CBC)
Time Frame: Baseline, 4 weeks into RT, 4 week follow up visit
We will collect CBC data at each blood draw for correlative and explorative purposes.
Baseline, 4 weeks into RT, 4 week follow up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change in Cancer-related healthcare quality of life (HRQOL) measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires.
Time Frame: Baseline, 4 weeks into RT, 4 week follow up visit
The HRQOL measures four different domains (physical well-being, functional well-being, emotional well-being, and social/family well-being). FACT-B is a breast cancer specific module that will be used to reflect patients' concerns; moreover, they are reliable, reproducible, and have been validated in numerous studies.
Baseline, 4 weeks into RT, 4 week follow up visit

Collaborators and Investigators

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

Sponsor

Hackensack Meridian Health

Collaborators

Lombardi Comprehensive Cancer Center

Investigators

  • Principal Investigator: Brett Lewis, M.D., Ph.D, Hackensack UMC

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

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 (ACTUAL)

June 21, 2016

Primary Completion (ANTICIPATED)

May 1, 2026

Study Completion (ANTICIPATED)

May 1, 2026

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (ESTIMATE)

July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2016-0162

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.

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