Clinical trial · Interventional
Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment
'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
NCT03626610CI-TRIAL-00034315Pre-EMPTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
'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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Oesophageal Adenocarcinoma | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise prehabilitation during chemotherapy before surgery | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- Participants will be given a monitored exercise program during their treatment starting before chemotherapy
- interventionNames
- Behavioral: Exercise prehabilitation during chemotherapy before surgery
- type
- NO_INTERVENTION
- label
- Non-interventional
- description
- Patients will have standard care.
Primary outcomes (1)
- measure
- Cardiopulmonary fitness
- timeFrame
- Baseline to 5 months
- description
- Cardiopulmonary exercise test on bicycle ergometer
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. 18+ 3. \</=79 (patients above this age may be included in studies after the feasibility study has been completed) 4. Participants must be able to understand and independently consent to participation in the study. 5. Participants must be able to understand and complete the questionnaires. 6. 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. 7. Participants must be willing to wear the Fibit monitoring device and agree with its use 8. Participants must be ASA 1-3 and fit for surgical resection 9. 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. Exclusion Criteria: Participants will be excluded if they: 1. Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team 2. Will undergo primary or palliative chemotherapy 3. Are recommended to have chemoradiotherapy 4. Are under 18 years old 5. Are over 79 years old 6. Are unable to undergo CPEX testing 7. Do not wish to take part in selected aspects of the study 8. Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise 9. Cannot understand and give informed consent to the study 10. Cannot understand and complete the questionnaires 11. Do not wish to wear a Fitbit monitoring device 12. ASA 4+ 13. Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.
References
Publications (1)
- DERIVEDZylstra 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 35105604