Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study to Design and Investigate the Utility of a Simple, Home-Based, Exercise Intervention During Chemotherapy. (ChemoFit)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Feasibility study to investigate the utility of a simple, home-based, exercise intervention during and after neo-adjuvant chemotherapy but prior to surgery for esophageal and gastric adenocarcinoma.
详细描述
The principle aim of this study is to test the feasibility of utilising a home-based 'prehabilitation' exercise regimen in oesophago-gastric patients during preoperative chemotherapy and the period leading up to surgical resection. The investigators also hope to explore secondary outcomes of such a regimen, such as maintenance of fitness, the incidence of sarcopenia, muscle function and the outcomes of therapy. The investigators will explore the added value of blood-borne frailty biomarkers to objectively measure changes in physiology during neo-adjuvant chemotherapy (NAC). This will be tested using CPET, CT measured sarcopenia, grip strength and a small panel of biomarkers as secondary outcome and exploratory measures. Thus the main question is: 'Will patients participate in a home-based exercise programme during and after NAC for oesophago-gastric cancer?'
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Operable adenocarcinoma of the oesophagus, oesophago-gastric junction and stomach (locally advanced adenocarcinoma with planned preoperative chemotherapy, T3+, T1/2 N+)
- •Planned preoperative chemotherapy with ECX, ECX variant or FLOT chemotherapy
- •Ability to complete CPET
- •Ability to consent to study and carry out the planned intervention.
排除标准
- •Standard contraindications to CPET testing as defined by ATS Guidance
- •Orthopaedic limitations to CPET and / or daily exercise, for example, amputation, severe knee or hip disease.
- •Inoperable cancer at initial screening MDT
- •Planned non-surgical treatment with either radiotherapy or combined chemoradiotherapy
研究组 & 干预措施
ChemoFit exercise prehabilitation intervention
Exercise intervention consisting of walking and increasing daily step count. This is monitored by wearing a pedometer device. Other part of intervention are 5 simple strengthening exercises.
干预措施: ChemoFit exercise prehabilitation intervention (Other)
结局指标
主要结局
Recruitment rate
时间窗: 1 year
Defined as the proportion of all patients approached that agree to enter the study.
Individual compliance
时间窗: 1 year
With the intervention, defined as the percentage of intervention days when the patient was wearing his/her pedometer, was contactable every week and was recording his/her daily step count.
Completion rate
时间窗: 1 year
Defined as the proportion of all patients that enter the study that remain participants at the end of the defined study period (at surgery).
次要结局
- Sarcopenia(1 year)
- Outcome of oncology treatment(1 year)
- Step count(1 year)
- Quality of life(1 year)
- CPET measurements(1 year)
- End of study questionnaire(1 year)
- Focus group(1 year)