Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.
研究概览
简要总结
Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.
The investigators wish to explore various hypotheses:
- Is exercise intervention feasible and tolerable in this cohort of patients?
- Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
- Can SRETP improve quality of life?
- Can SRETP improve physical activity?
- Can SRETP improve surgical outcome?
- Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.
The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust
排除标准
- •Unable to consent
- •Under 18 years of age
- •Unable to perform exercise
- •Meet any contraindications on the ATS CPET safety guidelines
结局指标
主要结局
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.
时间窗: 3 years
次要结局
- Other measures of physical fitness measured in CPET or the VO2 kinetics test(3 years)
- Adherence to a 6 week interval exercise intervention.(3 years)
- Optimal time for surgery indicating optimal oncological and physiological fitness(3 years)
- Health related quality of life improvement as measured by SF36, EORCT c30 v3(3 years)
- Outcome from major surgery measured by 5 day POMS(3 years)
- Activity levels before during and after neoadjuvant chemoradiotherapy(3 years)
研究者
Michelle Mossa
Research and Development Director
Liverpool University Hospitals NHS Foundation Trust