Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKing Hamad University Hospital, Bahrain
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Supervised exercise
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
King Hamad University Hospital, Bahrain
Lead sponsor
Bahrain Oncology Center
Collaborator
Source ClinicalTrials.gov