Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy (NCT06309290) | Clinical Trial Compass
RecruitingNot Applicable
Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy
Chile68 participantsStarted 2025-01-01
Plain-language summary
Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown.
Who can participate
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:
* Postmenopausal women with breast cancer in stages I, II and III with luminal breast tumor, HER2+ or TNBC
* Indication for neoadjuvant chemotherapy
* Candidates for curative breast surgery
* Body mass index: 18.5 \<BMI \<30 kg/m2
* Sedentary (does not perform scheduled or planned physical activity ≥ 2 times a week)
* Willingness to participate in the study and follow the proposed prehabilitation scheme.
Exclusion Criteria:
* Present comorbidities that interact with the metabolism and mobility of the muscles of the body and that do not allow the (safe) performance of strength exercises (e.g., debilitating arthritis, all neurological disorders, paralysis, among others).
* Severe or uncontrolled cardiovascular disease, cardiac ejection fraction less than 50%
* Previous antineoplastic treatment
* Use of nutritional supplements (leucine, glutamine, casein, whey protein, fatty acids and creatine).
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
Change in skeletal muscle mass (measured via Computed tomography (CT) scan)
Timeframe: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery