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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Supervised exercise
Other interventionSupervised combined aerobic and resistance exercise during neoadjuvant chemotherapy, delivered as two supervised sessions per week throughout the course of NACT.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Supervised exerciseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of exercise intervention during neoadjuvant chemotherapy
Exercise adherence will be assessed in the exercise arm using physiotherapist-maintained session logs. Adherence is defined as attendance at ≥65% of prescribed supervised sessions during NACT, calculated as (sessions attended / sessions prescribed) × 100%. Prescribed sessions are the supervised sessions scheduled for the participant from randomization until completion of NACT or withdrawal from the study, whichever occurs first. The intervention will be considered feasible if at least 50% of participants randomized to the exercise arm meet the adherence threshold.
Time frame
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.Secondary outcomes
1
CT-derived body composition
Skeletal muscle index (SMI) and subcutaneous fat index (SFI) will be measured on routine baseline and post-NACT computerized tomography (CT) images. SMI is defined as the cross-sectional area of skeletal muscle at the third lumbar vertebra (L3) on CT (in square centimeters) normalized for height (meters squared), yielding units of cm²/m². SFI is defined as the cross-sectional area of subcutaneous fat at the third lumbar vertebra (L3) on CT (in square centimeters) normalized for height (meters squared), yielding units of cm²/m².
Time frame
SMI and SFI will be assessed at two time points: at baseline (pre-NACT) and at completion of NACT, which is expected to occur approximately 4-6 months after initiation of NACT and prior to surgery (post-NACT).2
Pathologic Complete Response (pCR)
pCR is defined as the absence of residual invasive cancer in the resected breast specimen and lymph nodes following NACT (allowing for residual in situ carcinoma), commonly denoted ypT0/Tis, ypN0. pCR will be determined based on the post-surgical pathology report.
Time frame
Within one month after surgery.3
Chemotherapy Delivery and Dose Intensity
Relative Dose Intensity (RDI): RDI is defined as the delivered dose intensity (mg/m²/week for each cytotoxic drug) expressed as a percentage of the planned dose intensity. Dose reductions: Any reduction in chemotherapy dose below the initially planned dose (for reasons other than weight change) will be recorded. Cycle delays: Any delay of a chemotherapy cycle by ≥7 days from the intended date (for toxicity or other patient factors) will be recorded. Early discontinuation: If a patient permanently discontinues NACT before completing the planned number of cycles (due to toxicity, patient choice, etc.), that will be noted.
Time frame
From initiation through completion of NACT, approximately 4-6 months.4
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scores:
Quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 3 (EORTC QLQ-C30). Scores for each scale range from 0 to 100. Higher scores on the global health status and functioning scales indicate better health or functioning, while higher scores on the symptom scales indicate greater symptom severity.
Time frame
At baseline (pre-NACT) and at completion of NACT, which is expected to occur approximately 4-6 months after initiation of NACT and prior to surgery (post-NACT).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King Hamad University Hospital, Bahrain
Lead sponsor
Bahrain Oncology Center
Collaborator
Source ClinicalTrials.gov
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