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Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02846389
Collaborator
Lombardi Comprehensive Cancer Center (Other)
24
Enrollment
1
Location
2
Arms
118.3
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Moderate Exercise
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer
Actual Study Start Date :
Jun 21, 2016
Anticipated Primary Completion Date :
May 1, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Assessment of change in fatigue via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) survey instrument. [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.

  2. Assessment of change in blood biomarker of inflammation: High sensitivity CRP (hsCRP) [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%.

  3. Assessment of change in blood biomarker of inflammation: Serum fibrinogen [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%.

  4. Assessment of change in blood biomarker of inflammation: Ferritin [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%.

  5. Complete blood count data (CBC) [Baseline, 4 weeks into RT, 4 week follow up visit]

    We will collect CBC data at each blood draw for correlative and explorative purposes.

Secondary Outcome Measures

  1. Assessment of change in Cancer-related healthcare quality of life (HRQOL) measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hackensack University Medical Center Hackensack New Jersey United States 07601

Sponsors and Collaborators

  • Hackensack Meridian Health
  • Lombardi Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hackensack Meridian Health
ClinicalTrials.gov Identifier:
NCT02846389
Other Study ID Numbers:
  • Pro2016-0162
First Posted:
Jul 27, 2016
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Hackensack Meridian Health
Radiation therapy for Breast Cancer
Additional relevant MeSH terms:
Fatigue

Study Results

No Results Posted as of Aug 24, 2021