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- Klinische proef NCT02962219
Exercise Prior to Oesophagectomy (ExPO)
8 november 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Verwacht)
32
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Norfolk
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Norwich, Norfolk, Verenigd Koninkrijk, NR4 7TJ
- Werving
- University of East Anglia
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Contact:
- Professor Andrew Hart
- Telefoonnummer: 01603 593611
- E-mail: a.hart@uea.ac.uk
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Contact:
- Dr Stephen Lam
- Telefoonnummer: 01603 286286
- E-mail: stephen.lam@uea.ac.uk
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Controle
Standaard zorg
|
Written advice on exercise at home
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Experimenteel: 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) .
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Recruitment rate
Tijdsspanne: 0 months
|
The number of participants recruited from all eligible patients
|
0 months
|
Drop-out rate
Tijdsspanne: 12 months
|
Number of patients that drop-out from trial
|
12 months
|
Decline rate
Tijdsspanne: 0 months
|
Number of patients that decline to participate in the trial
|
0 months
|
Change in physical activity levels
Tijdsspanne: 0 and 4 months
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Measured with International Physical Activity Questionnaire (IPAQ)
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0 and 4 months
|
Change in attitudes to exercise
Tijdsspanne: 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
Tijdsspanne: 12 months
|
Physical activity diary used to assess adherence
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12 months
|
Adverse Events
Tijdsspanne: 12 months
|
The number of adverse events during the trial assessed using CTCAE
|
12 months
|
Change in physiological fitness
Tijdsspanne: 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
|
Change in respiratory muscle strength
Tijdsspanne: 0 and 4 months
|
Assessed with mean inspiratory pressure testing in cmH20
|
0 and 4 months
|
Post-operative cardiopulmonary complications
Tijdsspanne: 90-days post surgery
|
Cardiopulmonary complication rates as per ECCG definition.
|
90-days post surgery
|
Post-operative non-cardiopulmonary complications
Tijdsspanne: 90-days post surgery
|
Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.
|
90-days post surgery
|
Post-operative length of stay
Tijdsspanne: 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
Tijdsspanne: 90-days post surgery
|
Number of post-operative deaths
|
90-days post surgery
|
Change in Quality of Life
Tijdsspanne: 0, 4, 7 months
|
Assessed using QLQ C30 and OG25
|
0, 4, 7 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2016
Primaire voltooiing (Verwacht)
1 september 2017
Studie voltooiing (Verwacht)
1 april 2018
Studieregistratiedata
Eerst ingediend
28 oktober 2016
Eerst ingediend dat voldeed aan de QC-criteria
8 november 2016
Eerst geplaatst (Schatting)
11 november 2016
Updates van studierecords
Laatste update geplaatst (Schatting)
11 november 2016
Laatste update ingediend die voldeed aan QC-criteria
8 november 2016
Laatst geverifieerd
1 november 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Pathologische processen
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Hoofd- en nekneoplasmata
- Slokdarmaandoeningen
- Adenocarcinoom
- Postoperatieve complicaties
- Slokdarmneoplasmata
Andere studie-ID-nummers
- 206608
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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