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| Name | Class |
|---|---|
| Newcastle University | OTHER |
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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.
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?'
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChemoFit exercise prehabilitation intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChemoFit exercise prehabilitation intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Defined as the proportion of all patients approached that agree to enter the study. | 1 year |
| Completion rate | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CPET measurements | Cardiopulmonary fitness measured by cardiopulmonary exercise testing. | 1 year |
| Sarcopenia | Change in amount of L3 level skeletal muscle area |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome measures | Circulating biomarkers that measure frailty and immune function | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust | Recruiting | Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36137639 | Derived | 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. | |
| 35945625 |
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| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
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|
| 1 year |
| Sarcopenia | Change in grip strength | 1 year |
| Step count | Change in daily step count from pedometer each day | 1 year |
| Quality of life | Quality of life using QLQ-C30 and QLQ-OG25 questionnaires | 1 year |
| End of study questionnaire | Subjective perception of intervention using questionnaire | 1 year |
| Focus group | End of study 'PPI' focus group to assess exercise intervention | 1 year |
| Outcome of oncology treatment | Percentage of planned chemotherapy delivered | 1 year |
| Outcome of oncology treatment | Number of patients with dose reductions or who terminate chemotherapy early | 1 year |
| Outcome of oncology treatment | Admissions to hospital with chemotherapy induced toxicity | 1 year |
| Derived |
| 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. |
| 32346484 | Derived | 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. |