Effect of Pre-operative Exercise Training on Cardiorespiratory Fitness in Patients With Locally Advanced Non-small Cell Lung Cancer Undergoing Induction Chemo-immunotherapy Followed by Surgery - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Change in peak oxygen uptake (VO₂peak) from baseline to pre-surgery
研究概览
简要总结
The PREHAB study focuses on patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection. These systemic treatments frequently impair patients' physiological reserve, reduce physical fitness, and may occasionally lead to cancellation of surgery. Surgery itself carries a substantial risk of cardiorespiratory complications and long-term functional decline.
The primary objective of this study is to determine whether a supervised exercise program, initiated concomitantly with systemic therapy and continued until surgery, can improve cardiorespiratory fitness, surgical tolerance, and postoperative outcomes.
A total of 74 patients will be randomly assigned to one of two groups: an "intervention" group participating in three weekly sessions of supervised endurance and resistance training for 12 to 16 weeks under the guidance of a physiotherapist, and a "control" group receiving usual care without a structured exercise program.
The primary endpoint will be peak oxygen uptake (VO₂peak). Secondary outcomes will include postoperative complication rates, length of hospital stay, pulmonary function, skeletal muscle mass, and quality of life.
Intervention-related risks, primarily falls or overexertion, will be mitigated through professional supervision. This multicenter study, with recruitment scheduled to begin in 2026, is expected to provide robust evidence regarding the effectiveness of targeted exercise training in improving preoperative fitness and postoperative recovery in patients with locally advanced NSCLC.
详细描述
The PREHAB study is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy of a structured, supervised prehabilitation program in patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection.
Patients with stage III NSCLC increasingly receive multimodal treatment strategies combining systemic therapy followed by surgery. While neoadjuvant chemotherapy and immunotherapy have improved oncologic outcomes, these treatments frequently induce treatment-related deconditioning, sarcopenia, fatigue, and reduced cardiopulmonary reserve. Consequently, a subset of patients experiences functional decline significant enough to compromise surgical eligibility. Moreover, thoracic surgery itself is associated with substantial postoperative morbidity, particularly cardiorespiratory complications, and long-term impairment in physical performance.
The PREHAB trial is based on the hypothesis that early, structured, and supervised exercise training initiated concomitantly with systemic therapy and continued until surgery can mitigate treatment-induced physiological deterioration, preserve or enhance cardiorespiratory fitness, and ultimately improve perioperative and postoperative outcomes.
A total of 74 patients will be randomized in a 1:1 ratio to either:
- Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists.
- Control group: standard oncologic care without a structured exercise intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Confirmed diagnosis of stage IIB, IIIA, IIIB or oligo-metastatic stage IV NSCLC.
- •Planned induction therapy with either chemotherapy, immunotherapy or a combination of immuno-chemotherapy followed by an anatomical pulmonary resection.
- •Absence of musculoskeletal conditions preventing safe physical exercise.
- •Absence of any history of uncontrolled or unstable cardiac disease.
- •Agreement to participate in the study by signing the study specific informed consent form.
排除标准
- •Pregnancy (confirmed by a test if applicable).
- •Induction therapy already initiated.
- •Inability to walk independently.
- •Lack of decision-making capacity.
- •Oxygen-dependency before the initiation of the induction protocol.
- •No capacity for discernment.
- •Does not speak French.
研究组 & 干预措施
Intervention
Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists.
干预措施: Preoperative Exercise Training (Procedure)
Control
Control group: standard oncologic care without a structured exercise intervention.
结局指标
主要结局
Change in peak oxygen uptake (VO₂peak) from baseline to pre-surgery
时间窗: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
The primary endpoint is peak oxygen uptake (VO₂peak), measured by standardized cardiopulmonary exercise testing (CPET). VO₂peak reflects the integrative capacity of the cardiovascular, pulmonary, and muscular systems during maximal exertion and is a validated indicator of surgical fitness and perioperative risk. VO₂peak will be assessed at baseline (before induction therapy) and repeated 24-72 hours prior to surgery. The primary analysis will compare pre-surgery VO₂peak between groups using ANCOVA adjusted for baseline VO₂peak.
次要结局
- Change in ventilatory efficiency (VE/VCO₂ slope) from baseline to pre-surgery(From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.)
- Change in 6-minute walk distance from baseline to pre-surgery(From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.)
- Rate of 30-day postoperative cardiopulmonary complications(From surgery to 30 days postoperatively.)
- Length of postoperative hospital stay(From surgery until hospital discharge.)
- Change in health-related quality of life (EORTC QLQ-C30 global score)(From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.)
- Change in skeletal muscle cross-sectional area on CT imaging(From baseline to 4-6 weeks prior to surgery at approximately 12 weeks.)
- Change in pulmonary function (FEV1 and DLCO) from baseline to pre-surgery(From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.)