Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study

Gastric Adenocarcinoma Clinical Trial

— ChemoFit  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194463
• Other study ID #: 09041
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2020
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?'

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Other:
• ChemoFit exercise prehabilitation intervention
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.

Locations

Country	Name	City	State
United Kingdom	Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome measures	Circulating biomarkers that measure frailty and immune function	1 year
Primary	Recruitment rate	Defined as the proportion of all patients approached that agree to enter the study.	1 year
Primary	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
Primary	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	CPET measurements	Cardiopulmonary fitness measured by cardiopulmonary exercise testing.	1 year
Secondary	Sarcopenia	Change in amount of L3 level skeletal muscle area	1 year
Secondary	Sarcopenia	Change in grip strength	1 year
Secondary	Step count	Change in daily step count from pedometer each day	1 year
Secondary	Quality of life	Quality of life using QLQ-C30 and QLQ-OG25 questionnaires	1 year
Secondary	End of study questionnaire	Subjective perception of intervention using questionnaire	1 year
Secondary	Focus group	End of study 'PPI' focus group to assess exercise intervention	1 year
Secondary	Outcome of oncology treatment	Percentage of planned chemotherapy delivered	1 year
Secondary	Outcome of oncology treatment	Number of patients with dose reductions or who terminate chemotherapy early	1 year
Secondary	Outcome of oncology treatment	Admissions to hospital with chemotherapy induced toxicity	1 year