NCT07764341尚未招募不适用
Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer: Protocol for a Randomized Feasibility Trial
King Hamad University Hospital, Bahrain1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility of exercise intervention during neoadjuvant chemotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Supervised exercise
Experimental
Supervised combined aerobic and resistance exercise during neoadjuvant chemotherapy (NACT)
干预措施: Supervised exercise (Other)
Control
No Intervention
Usual oncologic care during neoadjuvant chemotherapy
结局指标
主要结局
Feasibility of exercise intervention during neoadjuvant chemotherapy
时间窗: 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.
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.
次要结局
- 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).)
- Muscle strength(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(From initiation of NACT through completion of NACT, approximately 4-6 months.)
- Radiologic response(After completion of NACT and prior to surgery, approximately 4-6 months after initiation of NACT.)
研究者
Dr. Zeki Surmeli
Consultant Medical Oncologist
King Hamad University Hospital, Bahrain
研究点 (1)
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