Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

NCT02846389 | Terminated Results

• 1 other identifier: Pro2016-0162
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Related Fatigue

Keywords

Radiation therapy for Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.

  The Functional Assessment of Chronic Illness Therapy (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 (52 being the total score allowed). The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability. Responses to questions are scored: Not at all (0), A little bit (1), Somewhat (2) Quite a bit (3), Very much (4). Some scores are reversed depending on the question. The sum of the item scores are multiplied by the number of items in the scale, then divide by the number of items answered. This produces the score. The higher the score, the better the QOL.

  Baseline, 4 weeks into RT

• Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)

  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%. Change is reported based on the difference in the group mean of Serum hsCRP level between baseline and T4 visit.

  Baseline, 4 weeks into RT

• Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen

  Fibrinogen will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations \<10%. Change is reported based on the difference in the group mean of Serum fibrinogen level between baseline and T4 visit.

  Baseline, 4 weeks into RT

• Assessment of Change in Blood Biomarker of Inflammation: Ferritin

  Ferritin will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations \<10%. Change is reported based on the difference in the group mean of ferritin levels between baseline and T4 visit.

  Baseline, 4 weeks into RT

Secondary Outcomes (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

Other Outcomes (1)

• Complete Blood Count Data (CBC)

  Baseline, 4 weeks into RT, 4 week follow up visit

Study Arms (2)

Moderate Exercise

EXPERIMENTAL

Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).

Other: Moderate Exercise

Control Group

NO INTERVENTION

No exercise

Interventions

Moderate Exercise OTHER

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.

Moderate Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women between the ages of 18 and 75 years
• histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
• radiation therapy naïve
• 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
• ambulatory
• negative serum pregnancy test and not planning to become pregnant in the next three months
• able to provide meaningful consent.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Lombardi Comprehensive Cancer Center: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (34)

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Results Point of Contact

• Title: Joshua Zenreich
• Organization: Hackensack Meridian Health

joshua.zenreich@hmhn.org

15519964248

Study Officials

• Brett Lewis, M.D., Ph.D

  Hackensack UMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 27, 2016
• Study Start: June 21, 2016
• Primary Completion: December 3, 2017
• Study Completion: December 3, 2017
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)