Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer (NCT07764341) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer
Bahrain80 participantsStarted 2026-09
Plain-language summary
The goal of this clinical trial is to learn whether supervised exercise is practical and safe for women receiving chemotherapy before surgery for breast cancer.
The main questions it aims to answer are:
* Can participants attend and complete the supervised exercise program during chemotherapy?
* Is the exercise program safe?
* Does exercise help maintain muscle mass, strength, quality of life, and chemotherapy delivery?
Participants will be assigned to either:
* supervised aerobic and strength exercise during chemotherapy, or
* usual care without a study exercise program. Researchers will compare the two groups before and after chemotherapy.
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
. Histologically confirmed invasive breast carcinoma, clinical stage I-III.
. Female, age ≥18 years.
. Planned to undergo standard neoadjuvant chemotherapy of ≥4 months duration with curative intent, followed by definitive surgery. This includes common regimens such as taxane- and anthracycline-based chemotherapy or TCHP (docetaxel, carboplatin, trastuzumab, pertuzumab) for HER2-positive disease.
. Availability of a baseline CT or PET/CT scan (as part of routine diagnosis or staging) that includes axial images at the third lumbar vertebra (L3) level, performed prior to starting NACT.
. Anticipated post-NACT CT or PET/CT scan (e.g. for re-staging) that includes the L3 level, to be performed after completion of NACT and before surgery per standard care practice.
. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
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
Feasibility of exercise intervention during neoadjuvant chemotherapy
Timeframe: From initiation of the supervised exercise program through completion of neoadjuvant chemotherapy. The exercise program will continue throughout the full course of neoadjuvant chemotherapy, approximately 4-6 months depending on the treatment regimen.
. Cleared by treating oncologist and physiotherapist as medically able to participate in a moderate-intensity exercise program (e.g. able to walk independently with or without an assistive device and perform basic resistance exercises).
. Able and willing to provide written informed consent.
Exclusion criteria
. Evidence of distant metastatic disease (stage IV) or treatment plan not aiming for curative intent.
. Unstable or severe cardiac, pulmonary, or other systemic comorbidities that would make moderate exercise unsafe, such as unstable angina or recent myocardial infarction, decompensated heart failure, uncontrolled severe arrhythmia, uncontrolled severe hypertension, or severe symptomatic lung disease.
. Major musculoskeletal or neurological conditions that would preclude safe participation in supervised exercise (e.g. unstable orthopedic injuries, severe neuropathy or neurologic deficit, or recent major surgery not yet recovered).
. Current second active malignancy (excluding second localized early breast cancer).
. Regular participation in ≥150 minutes per week of moderate-vigorous aerobic activity and ≥2 resistance training sessions per week in the 3 months before cancer diagnosis.
. Baseline imaging not available or not including L3, or patient unlikely to have a post-NACT scan including L3 (e.g. if they refuse imaging).
. CT images of insufficient quality (e.g. severe artifacts or truncated field of view at L3) that would prevent accurate muscle measurement.
. Pregnant or breastfeeding at the time of enrollment.