Esophageal AdenocarcinomaChemoFitNCT04194463
Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study
A study testing ChemoFit exercise prehabilitation intervention in people with Esophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma
- What is being tested?
- ChemoFit exercise prehabilitation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Rhona Sinclair, 0191 2336161, rhona.sinclair@nuth.nhs.uk
Jakub Chmelo, jakub.chmelo@nuth.nhs.uk
About this 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)
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.
Read the 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?'
- Conditions
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma
- Being tested
- ChemoFit exercise prehabilitation intervention
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoFit exercise prehabilitation interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ChemoFit exercise prehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Defined as the proportion of all patients approached that agree to enter the study.
Measured: 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).
Measured: 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.
Measured: 1 year
Secondary outcomes (10)
CPET measurements
Cardiopulmonary fitness measured by cardiopulmonary exercise testing.
Measured: 1 year
Sarcopenia
Change in amount of L3 level skeletal muscle area
Measured: 1 year
Sarcopenia
Change in grip strength
Measured: 1 year
Step count
Change in daily step count from pedometer each day
Measured: 1 year
Quality of life
Quality of life using QLQ-C30 and QLQ-OG25 questionnaires
Measured: 1 year
End of study questionnaire
Subjective perception of intervention using questionnaire
Measured: 1 year
Focus group
End of study 'PPI' focus group to assess exercise intervention
Measured: 1 year
Outcome of oncology treatment
Percentage of planned chemotherapy delivered
Measured: 1 year
Outcome of oncology treatment
Number of patients with dose reductions or who terminate chemotherapy early
Measured: 1 year
Outcome of oncology treatment
Admissions to hospital with chemotherapy induced toxicity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start28 Feb 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194463
- Sponsor's protocol ID
- 09041
- Acronym
- ChemoFit
- Status last verified
- Mar 2020
- First submitted
- 1 Oct 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36137639Chmelo 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.
PubMed 35945625Chmelo 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.
PubMed 32346484
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04194463
- Acronym / sponsor ID
- ChemoFit / 09041
- Conditions
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?'
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ChemoFit exercise prehabilitation intervention | Experimental | Other: ChemoFit exercise prehabilitation interventionExercise 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoFit exercise prehabilitation interventionExercise 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. | Other | ChemoFit exercise prehabilitation intervention |
Primary outcome
Recruitment rate
Time frame: 1 year
Defined as the proportion of all patients approached that agree to enter the study.
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).
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.
10 secondary outcomes
CPET measurements
Time frame: 1 year
Sarcopenia
Time frame: 1 year
Sarcopenia
Time frame: 1 year
Step count
Time frame: 1 year
Quality of life
Time frame: 1 year
End of study questionnaire
Time frame: 1 year
Focus group
Time frame: 1 year
Outcome of oncology treatment
Time frame: 1 year
Outcome of oncology treatment
Time frame: 1 year
Outcome of oncology treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 36137639Cooper 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.
- Derived from this study: PubMed 35945625Chmelo 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.
- Derived from this study: PubMed 32346484Chmelo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChemoFit exercise prehabilitation intervention in people with Esophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.