Clinical trial · Interventional
Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery
A Single-centre Two-armed Randomised Controlled Trial Comparing Standard Care Alone Versus Exercise and Nutrition Prehabilitation in Elective Patients Undergoing Resectional HPB and Colorectal Cancer Surgery
NCT04880772CI-TRIAL-00069391SPECScompletedN/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)
To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery
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 |
|---|---|---|---|
| Cancer of Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
| Cancer of Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard care
- description
- Standard Care: Surgery school as per ELHT pre-operative guidelines (includes generic pre-operative information, advice and optimisation e.g correction of anaemia)
- type
- EXPERIMENTAL
- label
- Prehabilitation
- description
- Surgery School plus Moderate intensity exercise \& Forceval (multivitamin)
- interventionNames
- Other: Prehabilitation
Primary outcomes (2)
- measure
- Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min
- timeFrame
- change in baseline AT & VO2 peak at 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18-85 * Sex: male/female * Radiological/tissue cancer diagnosis * Curative cancer of the colon, rectum, colorectal liver metastases (CRLM) of 2 or more segments * elective surgery (planned a minimum of 3 weeks from the date of first clinic meeting) * Access to digital technology(mobile phone, tablet or laptop, home computer) to participate in supervised home exercise Exclusion Criteria: Exclusion * Palliative disease * Haematological malignancy * Pregnancy * Emergency surgery * Physically unable to undergo CPET * Part of any other trial with similar interventions unless previously agreed on with all CIs * synchronous disease (operation on HPB \& colorectal cancers at the same operation) * No access to digital technology(smart phone, tablet, laptop or home computer)
References
Publications (1)
- BACKGROUNDLambert JE, Hayes LD, Keegan TJ, Subar DA, Gaffney CJ. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Ann Surg. 2021 Jul 1;274(1):70-77. doi: 10.1097/SLA.0000000000004527. PMID 33201129