Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer

NCT07764341 | Not Yet Recruiting

• 1 other identifier: RMS- BOC/IRB/ 2026 - 1181
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Neoplasm Malignant Female

Keywords

breast cancer; sarcopenia; neoadjuvant chemotherapy; exercise; resistance training; body composition; physical activity; quality of life; skeletal muscle; pathologic complete response; relative dose intensity

Outcome Measures

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.

  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

  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)

  Within one month after surgery.

• Chemotherapy Delivery and Dose Intensity

  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:

  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:

  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).

Study Arms (2)

Supervised exercise

EXPERIMENTAL

Supervised combined aerobic and resistance exercise during neoadjuvant chemotherapy (NACT)

Other: Supervised exercise

Control

NO INTERVENTION

Usual oncologic care during neoadjuvant chemotherapy

Interventions

Supervised exercise OTHER

Supervised combined aerobic and resistance exercise during neoadjuvant chemotherapy, delivered as two supervised sessions per week throughout the course of NACT.

Supervised exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain: lead
• Bahrain Oncology Center: collaborator

Study Sites (1)

Bahrain Oncology Center

Al Muharraq, Bahrain

Location

MeSH Terms

Conditions

Breast Neoplasms; Sarcopenia; Motor Activity; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior; Disease Progression; Disease Attributes; Pathologic Processes

Central Study Contacts

Zeki G Surmeli

CONTACT

+97339362234; zeki.surmeli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Medical Oncologist

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

BA (1)