Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT07764341
Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer
A study testing Supervised exercise in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Neoplasm Malignant Female, run by King Hamad University Hospital, Bahrain at 1 site in Bahrain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Neoplasm Malignant Female
- What is being tested?
- Supervised exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBahrain
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Able to understand study instructions and complete questionnaires.
Who cannot join
- 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).
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- 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.
- Significant cognitive impairment, psychiatric disorder, or language barrier that would prevent informed consent or compliance with the protocol.
- Any other condition or circumstance that, in the opinion of the investigator, would make participation not in the patient's best interest or would compromise the scientific integrity of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bahrain1 site
Bahrain Oncology Center
Al Muharraq
Zeki G Surmeli, +97339362234, zeki.surmeli@gmail.com
About this study
Official title: Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer: Protocol for a Randomized Feasibility 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.
- Being tested
- Supervised exercise
- Keywords
- breast cancer, sarcopenia, neoadjuvant chemotherapy, exercise, resistance training, body composition, physical activity, quality of life, skeletal muscle, pathologic complete response, relative dose intensity
- Medical subject headings
- Breast Neoplasms, Sarcopenia, Motor Activity, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseOther
Supervised combined aerobic and resistance exercise during neoadjuvant chemotherapy, delivered as two supervised sessions per week throughout the course of NACT.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise | Experimental | Supervised combined aerobic and resistance exercise during neoadjuvant chemotherapy (NACT) Receives: Other: Supervised exercise |
| Control | No intervention | Usual oncologic care during neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
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.
Measured: 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).
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.
Measured: Within one month after surgery.
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.
Measured: From initiation through completion of NACT, approximately 4-6 months.
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.
Measured: 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).
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 23 Scores:
Breast cancer-specific quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 23 (EORTC QLQ-BR23). Scores for each scale range from 0 to 100. Higher scores on the functioning scales indicate better functioning, while higher scores on the symptom scales indicate greater symptom severity.
Measured: 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).
Muscle strength
Grip (in kg) strength will be assessed using handgrip dynamometry.
Measured: Grip strength will be measured 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).
Safety and adverse events
Safety will be evaluated by tracking adverse events (AEs) and serious adverse events (SAEs) throughout the study, particularly any events related to the exercise intervention. All participants will be assessed at each clinical visit for adverse events, and exercise session logs will also capture any symptoms or events during or after exercise.
Measured: From initiation of NACT through completion of NACT, approximately 4-6 months.
Radiologic response
Tumor response on imaging will be assessed by RECIST 1.1 criteria on post-NACT scans.
Measured: After completion of NACT and prior to surgery, approximately 4-6 months after initiation of NACT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Hamad University Hospital, Bahrain
- Sponsor type
- University, hospital or other
- Collaborators
- Bahrain Oncology Center
- Responsible party
- Principal investigator, Dr. Zeki Surmeli, King Hamad University Hospital, Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764341
- Sponsor's protocol ID
- RMS- BOC/IRB/ 2026 - 1181
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided