Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study (ChemoFit)
11. mars 2020 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
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?'
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tyne And Wear
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Newcastle Upon Tyne, Tyne And Wear, Storbritannia, NE1 4LP
- Rekruttering
- Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
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Ta kontakt med:
- Rhona Sinclair
- Telefonnummer: 0191 2336161
- E-post: rhona.sinclair@nuth.nhs.uk
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Ta kontakt med:
- Jakub Chmelo
- E-post: jakub.chmelo@nuth.nhs.uk
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Hovedetterforsker:
- Rhona Sinclair
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recruitment rate
Tidsramme: 1 year
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Defined as the proportion of all patients approached that agree to enter the study.
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1 year
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Completion rate
Tidsramme: 1 year
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Defined as the proportion of all patients that enter the study that remain participants at the end of the defined study period (at surgery).
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1 year
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Individual compliance
Tidsramme: 1 year
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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.
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1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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CPET measurements
Tidsramme: 1 year
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Cardiopulmonary fitness measured by cardiopulmonary exercise testing.
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1 year
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Sarcopenia
Tidsramme: 1 year
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Change in amount of L3 level skeletal muscle area
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1 year
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Sarcopenia
Tidsramme: 1 year
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Change in grip strength
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1 year
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Step count
Tidsramme: 1 year
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Change in daily step count from pedometer each day
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1 year
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Quality of life
Tidsramme: 1 year
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Quality of life using QLQ-C30 and QLQ-OG25 questionnaires
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1 year
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End of study questionnaire
Tidsramme: 1 year
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Subjective perception of intervention using questionnaire
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1 year
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Focus group
Tidsramme: 1 year
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End of study 'PPI' focus group to assess exercise intervention
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1 year
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Outcome of oncology treatment
Tidsramme: 1 year
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Percentage of planned chemotherapy delivered
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1 year
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Outcome of oncology treatment
Tidsramme: 1 year
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Number of patients with dose reductions or who terminate chemotherapy early
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1 year
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Outcome of oncology treatment
Tidsramme: 1 year
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Admissions to hospital with chemotherapy induced toxicity
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1 year
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Exploratory outcome measures
Tidsramme: 1 year
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Circulating biomarkers that measure frailty and immune function
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1 year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. februar 2019
Primær fullføring (Forventet)
30. juni 2020
Studiet fullført (Forventet)
30. juni 2020
Datoer for studieregistrering
Først innsendt
1. oktober 2019
Først innsendt som oppfylte QC-kriteriene
9. desember 2019
Først lagt ut (Faktiske)
11. desember 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09041
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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