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

March 11, 2020 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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?'

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
        • Recruiting
        • Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rhona Sinclair

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 1 year
Defined as the proportion of all patients approached that agree to enter the study.
1 year
Completion rate
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPET measurements
Time Frame: 1 year
Cardiopulmonary fitness measured by cardiopulmonary exercise testing.
1 year
Sarcopenia
Time Frame: 1 year
Change in amount of L3 level skeletal muscle area
1 year
Sarcopenia
Time Frame: 1 year
Change in grip strength
1 year
Step count
Time Frame: 1 year
Change in daily step count from pedometer each day
1 year
Quality of life
Time Frame: 1 year
Quality of life using QLQ-C30 and QLQ-OG25 questionnaires
1 year
End of study questionnaire
Time Frame: 1 year
Subjective perception of intervention using questionnaire
1 year
Focus group
Time Frame: 1 year
End of study 'PPI' focus group to assess exercise intervention
1 year
Outcome of oncology treatment
Time Frame: 1 year
Percentage of planned chemotherapy delivered
1 year
Outcome of oncology treatment
Time Frame: 1 year
Number of patients with dose reductions or who terminate chemotherapy early
1 year
Outcome of oncology treatment
Time Frame: 1 year
Admissions to hospital with chemotherapy induced toxicity
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcome measures
Time Frame: 1 year
Circulating biomarkers that measure frailty and immune function
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Collaborators

Newcastle University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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