Inspiratory Muscle Training in Obese Breast Cancer Survivors (NCT05193149) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Inspiratory Muscle Training in Obese Breast Cancer Survivors
United States77 participantsStarted 2023-11-13
Plain-language summary
The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.
Who can participate
Age range
18 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:
* completed active treatment for a Stage 0-III breast cancer diagnosis within 6 months to 5 years of enrollment.
* obese as defined by a body mass index (BMI) of 30 to 50 kg/m2
* patients who are on adjuvant endocrine therapy will be allowed to participate.
* sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance
Exclusion Criteria:
* functional limitations that make independent exercise unsafe
* metastatic breast cancer
* ongoing or active infection with recent antibiotics or steroids
* Bilateral Axillary lymph node dissection (ALND) of \>5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed.
* heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia)
* psychiatric illness/social situations that would limit compliance with study requirements
* orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
* unwilling or unable to follow protocol requirements
* pregnant or nursing
* any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate …
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.
1This trial focuses on inspiratory muscle training for breast cancer survivors who are also obese — given my specific health history, do you think my lung and breathing fitness is something that needs attention, and could this kind of training realistically help me?
2Since this trial is no longer recruiting, are there similar studies or programs looking at breathing muscle training or exercise tolerance in breast cancer survivors that I might still be able to join?
3The trial is measuring changes in exercise tolerance — can you explain what 'exercise tolerance' means in practical terms for someone in my situation, and how would we know if my current level is a concern worth addressing?
4This is listed as Phase NA, which often means it's more of a feasibility or pilot study — what does that mean for how much we'd know about safety and benefit from the results, and should that affect how seriously I consider this approach?
5Are there standard rehabilitation or exercise programs already available to me as a breast cancer survivor with obesity that might address similar breathing and fitness goals, without needing to participate in a research trial?
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
Change in exercise tolerance
Timeframe: Baseline to 4 weeks
2
Change in exercise tolerance
Timeframe: Baseline to 16 weeks
Trial details
NCT IDNCT05193149
SponsorOhio State University Comprehensive Cancer Center