- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02962219
Exercise Prior to Oesophagectomy (ExPO)
8. november 2016 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
32
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Norfolk
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Norwich, Norfolk, Storbritannia, NR4 7TJ
- Rekruttering
- University of East Anglia
-
Ta kontakt med:
- Professor Andrew Hart
- Telefonnummer: 01603 593611
- E-post: a.hart@uea.ac.uk
-
Ta kontakt med:
- Dr Stephen Lam
- Telefonnummer: 01603 286286
- E-post: stephen.lam@uea.ac.uk
-
-
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:
- 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Styre
Standard omsorg
|
Written advice on exercise at home
|
|
Eksperimentell: Intervention
A pre-operative personalised exercise programme (my-PEP).
|
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) .
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate
Tidsramme: 0 months
|
The number of participants recruited from all eligible patients
|
0 months
|
|
Drop-out rate
Tidsramme: 12 months
|
Number of patients that drop-out from trial
|
12 months
|
|
Decline rate
Tidsramme: 0 months
|
Number of patients that decline to participate in the trial
|
0 months
|
|
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
|
|
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
|
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
|
Assessed with mean inspiratory pressure testing in cmH20
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0 and 4 months
|
|
Post-operative cardiopulmonary complications
Tidsramme: 90-days post surgery
|
Cardiopulmonary complication rates as per ECCG definition.
|
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.
|
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
|
90-days post surgery
|
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Post-operative mortality
Tidsramme: 90-days post surgery
|
Number of post-operative deaths
|
90-days post surgery
|
|
Change in Quality of Life
Tidsramme: 0, 4, 7 months
|
Assessed using QLQ C30 and OG25
|
0, 4, 7 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. september 2016
Primær fullføring (Forventet)
1. september 2017
Studiet fullført (Forventet)
1. april 2018
Datoer for studieregistrering
Først innsendt
28. oktober 2016
Først innsendt som oppfylte QC-kriteriene
8. november 2016
Først lagt ut (Anslag)
11. november 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. november 2016
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Karsinom
- Neoplasmer, kjertel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Adenokarsinom
- Postoperative komplikasjoner
- Neoplasmer i spiserøret
Andre studie-ID-numre
- 206608
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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