Rehabilitative Strategies Following Oesophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Aerobic Fitness
研究概览
简要总结
The ReStOre trial is a multi-disciplinary intervention of exercise, diet and education for patients who have completed treatment for oesophageal cancer. The intervention aims to improve quality of life and functional performance following oesophageal cancer and assist patients to return to normal activity during the early survivorship phase. The 12-week intervention will involve structured exercise training, individual dietary advice and multi-disciplinary education sessions addressing a range of survivorship needs.
详细描述
The principal study proposed in this work will be composed of two phases. Phase I will consist of a longitudinal analysis, tracking the progression of cachexia and associated dysmetabolic state throughout treatment for oesophageal cancer (OC) and examining the impact of this decline on measures of physical functioning. A total of 88 newly-diagnosed OC patients will be recruited for Phase I. In Phase II, participants from Phase I will be re-assessed and if deemed suitable, will be enrolled onto a multidisciplinary team rehabilitation programme aimed at improving functional status. This rehabilitation programme will take the form of a randomised controlled trial (RCT) and will be based on the well-established cardiac rehabilitation programme model. It is anticipated that approximately 50% of participants enrolled onto Phase I will be suitable for progression to Phase II.
Outcomes The primary outcome across both Phase I and Phase II is functional capacity. Secondary outcomes including inflammatory status, energy metabolism and nutritional status will be measured as appropriate during the study. All outcomes are discussed in detail elsewhere.
Phase I: Longitudinal Study Examining the impact of progressive cachexia, dysmetabolism and cancer treatment on functional capacity in OC patients
Phase I will be designed as a longitudinal analysis, commencing at the time of diagnosis, tracking the progression of cachexia and associated dysmetabolic state, incorporating inflammatory profiles, energy metabolism (oxidative phosphorylation and glycolysis) and gut hormones, throughout treatment for OC and examining the impact of this decline on measures of physical functioning. Assessments will be completed at diagnosis (T0), cycle 2 chemotherapy (T1), cycle 3 chemotherapy (T2), pre-oesophagectomy (T3), post-oesophagectomy (T4), 4-weeks post-surgery (T5) and six months post-surgery (T6). All assessments will be completed during the same day as routine out-patient appointments thereby reducing the burden on participants. Furthermore, blood samples will be taken during routine clinical sampling and CT scans will be completed as part of routine medical care.
Phase II: Randomised Controlled Trial Can rehabilitation following curative treatment for OC optimise health-related functional outcomes?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed treatment for oesophageal cancer to include oesophagectomy. Patients may have also been treated with neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy.
- •Curative treatment intent.
- •Age >18 years
- •Able to understand English
排除标准
- •Evidence of active or recurrent disease
研究组 & 干预措施
Rehabilitation Programme
12 week multi-disciplinary intervention prescribing exercise, individual dietary counselling and education sessions.
干预措施: Rehabilitation programme (Behavioral)
Control
Usual care control arm
结局指标
主要结局
Change in Aerobic Fitness
时间窗: Change from baseline in aerobic fitness at 12 weeks (end of intervention)
Aerobic fitness (ml/kg/min) will be measured by maximal cardiopulmonary exercise test
次要结局
- Change in physical activity levels(Change from baseline in physical activity at 12 weeks (end of intervention))
- Change in hand grip strength(Change from baseline in hand grip strength at 12 weeks (end of intervention))
- Change in Dietary Intake(Change from baseline in dietary intake at 12 weeks (end of intervention))
- Change in inflammatory status(Change from baseline in inflammatory status at 12 weeks (end of intervention))
- Change in body Composition(Change from baseline in body composition at 12 weeks (end of intervention))
- Change in energy metabolism(Change from baseline in energy metabolism at 12 weeks (end of intervention))
- Change in quality of Life(Change from baseline in quality of life at 12 weeks (end of intervention))
研究者
Prof Juliette Hussey
Professor
University of Dublin, Trinity College