Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study
ChemoFit
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2019
CompletedFirst Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMarch 12, 2020
March 1, 2020
1.3 years
October 1, 2019
March 11, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (10)
CPET measurements
1 year
Sarcopenia
1 year
Sarcopenia
1 year
Step count
1 year
Quality of life
1 year
- +5 more secondary outcomes
Other Outcomes (1)
Exploratory outcome measures
1 year
Study Arms (1)
ChemoFit exercise prehabilitation intervention
EXPERIMENTALExercise 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trustlead
- Newcastle Universitycollaborator
Study Sites (1)
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
Related Publications (3)
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.
PMID: 36137639DERIVEDChmelo 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.
PMID: 35945625DERIVEDChmelo 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.
PMID: 32346484DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
December 11, 2019
Study Start
February 28, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
March 12, 2020
Record last verified: 2020-03