- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02962219
Exercise Prior to Oesophagectomy (ExPO)
8. november 2016 opdateret af: University of East Anglia
A Pre-operative Personalised Exercise Programme to Improve Physical Fitness and Reduce Post-operative Cardiopulmonary Complications After Oesophagectomy in Patients With Oesophageal Adenocarcinoma: A Feasibility Randomised Controlled Trial
The purpose of this feasibility study is to determine whether a structured exercise programme prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological measures of physical fitness above standard care.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
The number of patients with oesophageal cancer is rising dramatically in the UK.
Curative cancer surgery (oesophagectomy) is offered to around 40% of affected patients.
However, oesophagectomy is a major operation with a high risk of complications.
Around 1 in 3 patients will suffer such a complication after surgery, mostly due to heart or lung problems.
Most complications are not due to the surgery itself, but related to the patient's physical fitness before their operation.
Studies in other surgeries, but not oesophagectomy, have shown that complications may be reduced by improving a patient's physical fitness before their operation.
The ExPO team has developed a pre-operative Personalised Exercise Programme (my-PEP), specifically for patients undergoing oesophagectomy.
my-PEP has 4 main components: three are exercise modalities (aerobic exercise, breathing exercises and muscle strengthening); the fourth is where a participant's potential barriers to exercise are assessed and behavioural change techniques (BCTs) are suggested to improve exercise engagement in the trial.
In total, 32 patients who are due to undergo oesophagectomy at the Norfolk and Norwich Hospital will be recruited and then randomly divided into 2 arms of 16 each.
One arm will receive my-PEP in the standard 3-4 months prior to surgery, the other will receive standard care advice to exercise at home.
The research objectives are to obtain feasibility data on whether my-PEP is acceptable, adhered to and safe, and whether it improves patient fitness above standard care.
Follow up will be 90 days after surgery to obtain a preliminary imprecise estimate of whether my-PEP reduces complications.
If the ExPO trial shows promise in these areas, this will inform and justify a future large multi-centre trial to definitively answer whether my-PEP can reduce complications after oesophagectomy.
If so, my-PEP could potentially change and improve the pre-operative management of oesophageal cancer patients across the NHS.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Norfolk
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Norwich, Norfolk, Det Forenede Kongerige, NR4 7TJ
- Rekruttering
- University of East Anglia
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Kontakt:
- Professor Andrew Hart
- Telefonnummer: 01603 593611
- E-mail: a.hart@uea.ac.uk
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Kontakt:
- Dr Stephen Lam
- Telefonnummer: 01603 286286
- E-mail: stephen.lam@uea.ac.uk
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-
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:
- Patients with oesophageal adenocarcinoma (OAC) who are scheduled for neoadjuvant chemotherapy and subsequent oesophagectomy.
- Must have histological evidence of OAC
- Must be capable of giving informed consent and complying with trial procedures.
Exclusion Criteria:
- Patients with oesophageal squamous cell carcinoma.
- Patients with concomitant illness or disability that makes them unsuitable for an exercise programme, as determined by a clinician (e.g. severe musculoskeletal or neurological disease, unstable angina, severe aortic stenosis, uncontrolled dysrhythmias and uncompensated heart failure).
- WHO performance status 3 (capable of only limited self-care, confined to a bed or chair more that 50% of waking hours) or greater.
- Grade 5 (too breathless to leave the house, or breathless when undressing) on MRC dyspnoea scale.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Styring
Standard pleje
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Written advice on exercise at home
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Eksperimentel: Intervention
A pre-operative personalised exercise programme (my-PEP).
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A pre-operative personalised exercise programme (my-PEP) consisting of: 1) actions to promote exercise, using behavioural change techniques (BCTs), 2) home inspiratory muscle training (IMT), 3) a home exercise programme (HEP) - which is also current standard care, 4) a 4 week hospital-supervised aerobic and muscle strengthening programme (Hos-PEP) .
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate
Tidsramme: 0 months
|
The number of participants recruited from all eligible patients
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0 months
|
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Drop-out rate
Tidsramme: 12 months
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Number of patients that drop-out from trial
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12 months
|
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Decline rate
Tidsramme: 0 months
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Number of patients that decline to participate in the trial
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0 months
|
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Change in physical activity levels
Tidsramme: 0 and 4 months
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Measured with International Physical Activity Questionnaire (IPAQ)
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0 and 4 months
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Change in attitudes to exercise
Tidsramme: 0 and 4 months
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Measured with Determinates of Physical Activity Questionnaire (DPAQ)
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0 and 4 months
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Trial Adherence
Tidsramme: 12 months
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Physical activity diary used to assess adherence
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12 months
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Adverse Events
Tidsramme: 12 months
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The number of adverse events during the trial assessed using CTCAE
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12 months
|
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Change in physiological fitness
Tidsramme: 0 and 4 months
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Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer
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0 and 4 months
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Change in respiratory muscle strength
Tidsramme: 0 and 4 months
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Assessed with mean inspiratory pressure testing in cmH20
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0 and 4 months
|
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Post-operative cardiopulmonary complications
Tidsramme: 90-days post surgery
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Cardiopulmonary complication rates as per ECCG definition.
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90-days post surgery
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Post-operative non-cardiopulmonary complications
Tidsramme: 90-days post surgery
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Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.
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90-days post surgery
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Post-operative length of stay
Tidsramme: 90-days post surgery
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Duration of post-operative stay in days
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90-days post surgery
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Post-operative mortality
Tidsramme: 90-days post surgery
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Number of post-operative deaths
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90-days post surgery
|
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Change in Quality of Life
Tidsramme: 0, 4, 7 months
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Assessed using QLQ C30 and OG25
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0, 4, 7 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
1. september 2016
Primær færdiggørelse (Forventet)
1. september 2017
Studieafslutning (Forventet)
1. april 2018
Datoer for studieregistrering
Først indsendt
28. oktober 2016
Først indsendt, der opfyldte QC-kriterier
8. november 2016
Først opslået (Skøn)
11. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Adenocarcinom
- Postoperative komplikationer
- Esophageale neoplasmer
Andre undersøgelses-id-numre
- 206608
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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