Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer (NCT02846389) | Clinical Trial Compass
TerminatedNot Applicable
Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
United States24 participantsStarted 2016-06-21
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.
Timeframe: Baseline, 4 weeks into RT
2
Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)
Timeframe: Baseline, 4 weeks into RT
3
Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen
Timeframe: Baseline, 4 weeks into RT
4
Assessment of Change in Blood Biomarker of Inflammation: Ferritin
. 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
. 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