Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study (ChemoFit)
2020年3月11日 更新者：Newcastle-upon-Tyne Hospitals NHS Trust
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)
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.
研究概览
详细说明
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?'
研究类型
介入性
注册 (预期的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Tyne And Wear
-
Newcastle Upon Tyne、Tyne And Wear、英国、NE1 4LP
- 招聘中
- Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
-
接触：
- Rhona Sinclair
- 电话号码：0191 2336161
- 邮箱：rhona.sinclair@nuth.nhs.uk
-
接触：
- Jakub Chmelo
- 邮箱：jakub.chmelo@nuth.nhs.uk
-
首席研究员：
- Rhona Sinclair
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
- Age >18
- Ability to complete CPET
- Ability to consent to study and carry out the planned intervention.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
Exercise intervention consists of walking monitored by wearing a pedometer device.
After a baseline measurement of participant's walking activity is done, increase in step count from baseline step count is prescribed.
This increase in step count is achieved by walking or jogging at moderate intensity for a target of 30 minutes per day, each day.
Participants are also encouraged to perform other physical if they wish and are able to.
Patients are regularly contacted by a member of the research team on a weekly basis and given an option to maintain or to increase their step count further.
The same approach is used after each week of the intervention.
Strengthening exercises will form a further part of the exercise intervention.
They are performed every day, 7 days a week.
Patients are supplied with resistance bands with handles.
They are educated on how to perform two repetitions of 5 simple exercises, each for 1 minute duration.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment rate
大体时间：1 year
|
Defined as the proportion of all patients approached that agree to enter the study.
|
1 year
|
|
Completion rate
大体时间：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).
|
1 year
|
|
Individual compliance
大体时间：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.
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CPET measurements
大体时间：1 year
|
Cardiopulmonary fitness measured by cardiopulmonary exercise testing.
|
1 year
|
|
Sarcopenia
大体时间：1 year
|
Change in amount of L3 level skeletal muscle area
|
1 year
|
|
Sarcopenia
大体时间：1 year
|
Change in grip strength
|
1 year
|
|
Step count
大体时间：1 year
|
Change in daily step count from pedometer each day
|
1 year
|
|
Quality of life
大体时间：1 year
|
Quality of life using QLQ-C30 and QLQ-OG25 questionnaires
|
1 year
|
|
End of study questionnaire
大体时间：1 year
|
Subjective perception of intervention using questionnaire
|
1 year
|
|
Focus group
大体时间：1 year
|
End of study 'PPI' focus group to assess exercise intervention
|
1 year
|
|
Outcome of oncology treatment
大体时间：1 year
|
Percentage of planned chemotherapy delivered
|
1 year
|
|
Outcome of oncology treatment
大体时间：1 year
|
Number of patients with dose reductions or who terminate chemotherapy early
|
1 year
|
|
Outcome of oncology treatment
大体时间：1 year
|
Admissions to hospital with chemotherapy induced toxicity
|
1 year
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exploratory outcome measures
大体时间：1 year
|
Circulating biomarkers that measure frailty and immune function
|
1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cooper M, Chmelo J, Sinclair RCF, Charman S, Hallsworth K, Welford J, Phillips AW, Greystoke A, Avery L. Exploring factors influencing uptake and adherence to a home-based prehabilitation physical activity and exercise intervention for patients undergoing chemotherapy before major surgery (ChemoFit): a qualitative study. BMJ Open. 2022 Sep 22;12(9):e062526. doi: 10.1136/bmjopen-2022-062526.
- Chmelo J, Phillips AW, Greystoke A, Charman SJ, Avery L, Hallsworth K, Welford J, Cooper M, Sinclair RCF. A feasibility trial of prehabilitation before oesophagogastric cancer surgery using a multi-component home-based exercise programme: the ChemoFit study. Pilot Feasibility Stud. 2022 Aug 9;8(1):173. doi: 10.1186/s40814-022-01137-6.
- Chmelo J, Phillips AW, Greystoke A, Charman SJ, Avery L, Hallsworth K, Welford J, Sinclair RCF. A feasibility study to investigate the utility of a home-based exercise intervention during and after neo-adjuvant chemotherapy for oesophago-gastric cancer-the ChemoFit study protocol. Pilot Feasibility Stud. 2020 Apr 23;6:50. doi: 10.1186/s40814-020-00597-y. eCollection 2020.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年2月28日
初级完成 (预期的)
2020年6月30日
研究完成 (预期的)
2020年6月30日
研究注册日期
首次提交
2019年10月1日
首先提交符合 QC 标准的
2019年12月9日
首次发布 (实际的)
2019年12月11日
研究记录更新
最后更新发布 (实际的)
2020年3月12日
上次提交的符合 QC 标准的更新
2020年3月11日
最后验证
2020年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.