A Novel Multimodal Intervention for Surgical Prehabilitation of Patients With Lung Cancer: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Feasibility: Recruitment rate
研究概览
简要总结
Lung cancer is the second most prevalent cancer in Canada and the leading cause of cancer-related mortality worldwide. Patients diagnosed at earlier (non-metastatic) stages are potential candidates for surgical tumor removal. However, they often present with poor nutritional status and physical function adding to the major catabolic stress imposed by surgery that negatively impacts recovery and survival after surgery. The purpose of this study is to investigate the potential benefits of a prehabilitation program that includes a combined nutritional supplement (whey protein, leucine, vitamin D and omega-3 fatty acids) with exercise and relaxation techniques for 4 weeks before surgery and continued for 8 weeks after surgery on functional pre- and postoperative outcomes, versus standard hospital care (control). Investigators will study whether the prehabilitation program improves physical performance, muscle mass and quality of life in patients undergoing lung cancer resection. The specific objective of this pilot study is to test feasibility and adherence to intervention, and generate pilot data to inform the design of a larger trial.
详细描述
RATIONALE: The preoperative period is an opportune time to actively engage and empower patients in improving their functional, nutritional and mental status in anticipation of the surgical stress. Considering that lung cancer patients often present with poor nutritional status and physical function prior to surgery providing a nutritional supplement to increase protein, leucine, vitamin D and omega-3 FA intake with a structured exercise program and relaxation techniques should improve muscle mass, strength and physical performance.
MAIN OBJECTIVE: to test the effect of a multimodal prehabilitation intervention (MM) combining a mixed-nutrient supplement with structured exercise training against standard of care (SOC), on functional pre- and postoperative outcomes in surgical patients with lung cancer, in an open-label RCT.
The present is a pilot study aiming to generate feasibility data (recruitment rate, compliance, attrition) and preliminary outcome data to support a larger trial.
STUDY DESIGN: Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC). After baseline assessment, patients will be randomized to either group in a 1:2 SOC:MM ratio using a computer-generated randomization scheme by block of four, with stratification by sex and functional capacity (< or > 400 m on the 6MWT). Consecutive adult patients scheduled for elective video-assisted thoracic surgery or open thoracotomy surgery of NSCLC stages I, II or IIIa, will be approached following their first appointment with their surgeon at the MUHC-Montreal General Hospital.
INTERVENTION: The EXP arm will ingest a multi-nutrient supplement consisting of whey protein + leucine and fish oil + vitamin D, perform structured exercise and relaxation techniques for 4 weeks prior to surgery and 8 weeks after surgery. Control group will received standard hospital care and education on benefits of physical activity and healthy diet. Outcome assessment will be performed at baseline, preoperative, 4 and 8 weeks postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •adult men and women with NSCLC stages I, II or IIIa, planned for video-assisted thoracic surgery (VATS) or open thoracotomy surgery for cancer resection or exploration.
排除标准
- •prior recent (<3 mo) chemotherapy, comorbidities contraindicating exercise (defined as CPET <10 mL O2/kg/min), walking aids other than a cane, glomerular filtration rate <30 mL/min/m2, allergy to milk or seafoods, chronic use of anti-coagulants, hypercalcemia, hypervitaminosis D, insufficient understanding of English or French language to provide informed consent. All medications and co-morbidities will be recorded. Patients taking vitamin D will continue their supplements; risk of potential overdosing will be monitored by serum 25(OH)D levels >80 nmol/L. Those taking n-3 FA supplements will be asked to withhold during the study.
结局指标
主要结局
Feasibility: Recruitment rate
时间窗: Over entire recruitment period (approximately 1 year)
Recruitment rate (measured in percent, compared to expected rates)
Feasibility: completion of study outcome assessment
时间窗: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
Completion of study outcome assessments (measured in percent, compared to expected rates)
Feasibility: Adherence to intervention
时间窗: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
Adherence to exercise and nutritional interventions (measured in percent, compared to expected rates)
次要结局
- Length of hospital stay(8-week postoperative)
- Functional walking capacity(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
- Muscle radiodensity(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
- Post-operative complications(8-week postoperative)
- Health related quality of life(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
- Quality of Life(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
- Muscle strength - handgrip(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
- Muscle strength - leg(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
- Muscle volume(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
- Body composition(Baseline, preoperative, 4-week postoperative and 8-week postoperative)
研究者
Stéphanie Chevalier
Associate Professor
McGill University