- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02962219
Exercise Prior to Oesophagectomy (ExPO)
8 november 2016 uppdaterad 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.
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Norfolk
-
Norwich, Norfolk, Storbritannien, NR4 7TJ
- Rekrytering
- University of East Anglia
-
Kontakt:
- Professor Andrew Hart
- Telefonnummer: 01603 593611
- E-post: a.hart@uea.ac.uk
-
Kontakt:
- Dr Stephen Lam
- Telefonnummer: 01603 286286
- E-post: stephen.lam@uea.ac.uk
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Kontrollera
Standardvård
|
Written advice on exercise at home
|
|
Experimentell: 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) .
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment rate
Tidsram: 0 months
|
The number of participants recruited from all eligible patients
|
0 months
|
|
Drop-out rate
Tidsram: 12 months
|
Number of patients that drop-out from trial
|
12 months
|
|
Decline rate
Tidsram: 0 months
|
Number of patients that decline to participate in the trial
|
0 months
|
|
Change in physical activity levels
Tidsram: 0 and 4 months
|
Measured with International Physical Activity Questionnaire (IPAQ)
|
0 and 4 months
|
|
Change in attitudes to exercise
Tidsram: 0 and 4 months
|
Measured with Determinates of Physical Activity Questionnaire (DPAQ)
|
0 and 4 months
|
|
Trial Adherence
Tidsram: 12 months
|
Physical activity diary used to assess adherence
|
12 months
|
|
Adverse Events
Tidsram: 12 months
|
The number of adverse events during the trial assessed using CTCAE
|
12 months
|
|
Change in physiological fitness
Tidsram: 0 and 4 months
|
Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer
|
0 and 4 months
|
|
Change in respiratory muscle strength
Tidsram: 0 and 4 months
|
Assessed with mean inspiratory pressure testing in cmH20
|
0 and 4 months
|
|
Post-operative cardiopulmonary complications
Tidsram: 90-days post surgery
|
Cardiopulmonary complication rates as per ECCG definition.
|
90-days post surgery
|
|
Post-operative non-cardiopulmonary complications
Tidsram: 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
Tidsram: 90-days post surgery
|
Duration of post-operative stay in days
|
90-days post surgery
|
|
Post-operative mortality
Tidsram: 90-days post surgery
|
Number of post-operative deaths
|
90-days post surgery
|
|
Change in Quality of Life
Tidsram: 0, 4, 7 months
|
Assessed using QLQ C30 and OG25
|
0, 4, 7 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2016
Primärt slutförande (Förväntat)
1 september 2017
Avslutad studie (Förväntat)
1 april 2018
Studieregistreringsdatum
Först inskickad
28 oktober 2016
Först inskickad som uppfyllde QC-kriterierna
8 november 2016
Första postat (Uppskatta)
11 november 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 november 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 november 2016
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Adenocarcinom
- Postoperativa komplikationer
- Esofagusneoplasmer
Andra studie-ID-nummer
- 206608
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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