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

11. marts 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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?'

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, Det Forenede Kongerige, NE1 4LP
        • Rekruttering
        • Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Rhona Sinclair

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: 1 year
Defined as the proportion of all patients approached that agree to enter the study.
1 year
Completion rate
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory outcome measures
Tidsramme: 1 year
Circulating biomarkers that measure frailty and immune function
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Samarbejdspartnere

Newcastle University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. februar 2019

Primær færdiggørelse (Forventet)

30. juni 2020

Studieafslutning (Forventet)

30. juni 2020

Datoer for studieregistrering

Først indsendt

1. oktober 2019

Først indsendt, der opfyldte QC-kriterier

9. december 2019

Først opslået (Faktiske)

11. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09041

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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