Clinical trial NCT02846389: Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
Official title: Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Related Fatigue
Keywords: Radiation therapy for Breast Cancer
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: Lombardi Comprehensive Cancer Center
First posted: 2016-07-27
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of change in fatigue via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) survey instrument.
timeFrame: Baseline, 4 weeks into RT, 4 week follow up visit
measure: Assessment of change in blood biomarker of inflammation: High sensitivity CRP (hsCRP)
timeFrame: Baseline, 4 weeks into RT, 4 week follow up visit
measure: Assessment of change in blood biomarker of inflammation: Serum fibrinogen
timeFrame: Baseline, 4 weeks into RT, 4 week follow up visit
measure: Assessment of change in blood biomarker of inflammation: Ferritin
timeFrame: Baseline, 4 weeks into RT, 4 week follow up visit
measure: Complete blood count data (CBC)
timeFrame: Baseline, 4 weeks into RT, 4 week follow up visit
Secondary outcomes:
measure: Assessment of change in Cancer-related healthcare quality of life (HRQOL) measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires.
timeFrame: Baseline, 4 weeks into RT, 4 week follow up visit
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack UMC
name: Brett Lewis, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
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