Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment
Pre-EMPT
'Pre-EMPT' - An Interventional Study to Assess the Effects of Pre-emptive Exercise , or 'Prehabilitation', in Patients Undergoing Peri-operative Treatment for Adenocarcinoma of the Oesophagus and Gastro-oesophageal Junction
1 other identifier
interventional
66
1 country
1
Brief Summary
'Pre-EMPT' - A cohort-controlled, interventional study to assess the effects of a pre-emptive exercise programme, or 'prehabilitation', in patients undergoing peri-operative chemotherapy for adenocarcinoma of the lower oesophagus and gastro-oesophageal junction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedAugust 13, 2018
August 1, 2018
3.5 years
July 24, 2018
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiopulmonary fitness
Cardiopulmonary exercise test on bicycle ergometer
Baseline to 5 months
Secondary Outcomes (10)
Post-operative complications
Date of surgery to date of discharge, up to 45 days post-surgery
Post-operative length of hospital stay
Date of surgery to date of discharge, up to 45 days post-surgery
Lean body mass
Baseline to 5 months
Daily activity levels
Baseline to 5 months
Sleep quality assessment
Baseline to 5 months
- +5 more secondary outcomes
Study Arms (2)
Interventional
EXPERIMENTALParticipants will be given a monitored exercise program during their treatment starting before chemotherapy
Non-interventional
NO INTERVENTIONPatients will have standard care.
Interventions
Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma
Eligibility Criteria
You may qualify if:
- Participants must be diagnosed with operable oesophageal and gastro-oesophageal adenocarcinoma and scheduled to undergo standard neo-adjuvant chemotherapy and oesophago-gastric surgery as recommended by the Multidisciplinary Meeting decision.
- \</=79 (patients above this age may be included in studies after the feasibility study has been completed)
- Participants must be able to understand and independently consent to participation in the study.
- Participants must be able to understand and complete the questionnaires.
- Participants must be willing to undergo all the standard assessments and interventions included in this study - CPEX testing, blood sampling, questionnaires and exercise intervention where appropriate.
- Participants must be willing to wear the Fibit monitoring device and agree with its use
- Participants must be ASA 1-3 and fit for surgical resection
- Patients should have a Body Mass Index (BMI) equal to or above 18.5 with less than 10% self-reported unintentional weight loss at diagnosis.
You may not qualify if:
- Participants will be excluded if they:
- Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team
- Will undergo primary or palliative chemotherapy
- Are recommended to have chemoradiotherapy
- Are under 18 years old
- Are over 79 years old
- Are unable to undergo CPEX testing
- Do not wish to take part in selected aspects of the study
- Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise
- Cannot understand and give informed consent to the study
- Cannot understand and complete the questionnaires
- Do not wish to wear a Fitbit monitoring device
- ASA 4+
- Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Thomas' Hospital
London, SE1 7EH, United Kingdom
Related Publications (1)
Zylstra J, Whyte GP, Beckmann K, Pate J, Santaolalla A, Gervais-Andre L, Russell B, Maisey N, Waters J, Tham G, Lagergren J, Green M, Kelly M, Baker C, Van Hemelrijck M, Goh V, Gossage J, Browning M, Davies A. Exercise prehabilitation during neoadjuvant chemotherapy may enhance tumour regression in oesophageal cancer: results from a prospective non-randomised trial. Br J Sports Med. 2022 Apr;56(7):402-409. doi: 10.1136/bjsports-2021-104243. Epub 2022 Feb 1.
PMID: 35105604DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Davies, MBChBMDFRCS
Consultant Surgeon
Central Study Contacts
Andrew Davies, MBChBMDFRCS
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2018
First Posted
August 13, 2018
Study Start
November 1, 2016
Primary Completion
May 1, 2020
Study Completion
June 1, 2021
Last Updated
August 13, 2018
Record last verified: 2018-08