Clinical trial NCT04194463: Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Adenocarcinoma
Gastric Adenocarcinoma
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Newcastle University
First posted: 2019-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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?'

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 year
measure: Completion rate
timeFrame: 1 year
measure: Individual compliance
timeFrame: 1 year
Secondary outcomes:
measure: CPET measurements
timeFrame: 1 year
measure: Sarcopenia
timeFrame: 1 year
measure: Sarcopenia
timeFrame: 1 year
measure: Step count
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: End of study questionnaire
timeFrame: 1 year
measure: Focus group
timeFrame: 1 year
measure: Outcome of oncology treatment
timeFrame: 1 year
measure: Outcome of oncology treatment
timeFrame: 1 year
measure: Outcome of oncology treatment
timeFrame: 1 year
Other outcomes:
measure: Exploratory outcome measures
timeFrame: 1 year
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Tyne And Wear
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.