The Effect of a Pre- and Post- Operative Exercise Programme Versus Standard Care on Physical Fitness in People With Upper Gastrointestinal Cancers- Study Protocol for a Randomised Control Trial: The PERIOP-OG Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Physical Fitness
研究概览
简要总结
Esophageal and gastric cancers are a considerable health burden. In the past 10 years the 5-year survival for both cancers has doubled. This is due to a number of factors including advances in neo adjuvant and adjuvant chemotherapy and radiotherapy. However, physical fitness significantly declines as a result of neo adjuvant an adjuvant therapy. From studies in other cancers it is known that peri operative training improves physical fitness, yet there is little research into its effects in those with upper gastrointestinal cancers. The aim of this study is to assess the effect of a pre-and post operative training program on patients with upper gastrointestinal cancers on their physical fitness and consequently their optimism, quality of life and post operative morbidity.
详细描述
The comparator in this study will be standard oncological care. There patients will receive the exact same care as the intervention group patients but will receive no exercise training program.
The primary goal of this multi-centre randomised controlled trial are to investigate the effects of peri-operative exercise training programmes on physical fitness, measured with a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer.
The secondary aims will look at the effect of peri-operative exercise training on patients quality of life, optimism and well being, post operative morbidity, nutritional status and blood markers of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
The investigator will be blinded to the allocation of the participants
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
- •Be 18 years of age or above;
- •Have confirmed Multi Disciplinary Team (MDT) evidence of adenocarcinoma or squamous cell cancer of the oesophagus, oesophago- gastric junction or stomach requiring neoadjuvant therapy and planned curative resection.
- •Be referred by a multidisciplinary team meeting for neo adjuvant chemotherapy or neo adjuvant chemoradiotherapy prior to planned oesophagectomy or gastrectomy.
- •Have measurement confirming (endoscopic or otherwise) that the tumour starts more than 5cm below cricopharyngeus;
- •Be fit for pre-operative anaesthesia and surgery
- •Be able to provide written informed consent.
排除标准
- •Inability to participate in the exercise program (unable to perform 6 Minute Walk Test, unable to attend for assessment of parameters at any time point).
- •Patients with high grade dysplasia (squamous cell or adenocarcinoma);
- •Patients who have or develop metastatic disease at time of enrolment or during their neoadjuvant therapy;
- •Patients being referred for primary surgery without requirement for neoadjuvant treatment;
- •Patients with squamous cell cancer of the oesophagus who the MDT recommends or who individually elect to undergo definitive chemoradiotherapy;
- •Evidence of previous/concomitant malignancy that would interfere with this treatment protocol;
- •Pregnancy;
- •Patients participating in other trials that would interfere with the implementation of this protocol at a particular site.
结局指标
主要结局
Change in Physical Fitness
时间窗: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
The primary goal of this multi-centre randomised controlled trial is to investigate the effects of peri-operative exercise training programmes on physical fitness, defined as the distance covered in metres and centimetres during a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer. To complete the Six Minute Walk Test, no warm up is permitted and participants rest in a seated position for 10 minutes prior to the test beginning. Participants walk up and down a 20m course marked by cones for 6 minutes under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions as well as encouragement is used. After 6 minutes, the participant stops and the distance covered in the final partial lap as measured and total distance covered is calculated. Change from baseline to post treatment difference between groups.
次要结局
- Change in Strength - The Sit to Stand Test(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Change in Strength - The Handgrip Test(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Change in Body Composition(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Change in Physical Activity - Accelerometer(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Change in Quality of Life measured using the EQ-5D Health Questionnaire(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Change in Optimism(Baseline, Change from baseline to one week before surgery)
- Change in Well Being-The Functional Assessment of Cancer Therapy (FACT-E) questionnaire.(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Well Being - Semi-structured Interviews.(One week before surgery)
- Change in Well Being - Self-efficacy (General Self Efficacy Scale)(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Change in Well Being - Mastery (Pearlin Mastery Scale).(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery)
- Fear of Surgery Questionnaire(One week before surgery)
- Post Operative Morbidity - Post Operative Morbidity Score (POMS)(Day 30 post surgery)
- Post Operative Morbidity -Clavien-Dindo Classification of Surgical Outcomes(Day 30 post surgery)
- Change in Nutritional Status -Assessed using Glasgow Prognostic Score(Baseline, one week after completion of neo adjuvant treatment, one week before surgery,15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery)
- Change in Nutritional Status -Assessed using Foodbook 24(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, weeks after surgery, twelve weeks after surgery)
- Change in concentration of blood markers of Inflammation- C-Reactive Protein(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery)
- Change in concentration of blood markers of Inflammation- White Cell Differential(Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery)