Clinical trial · Interventional
Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients
Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.
NCT04167436CI-TRIAL-00056861unknownPhase 2 / Phase 3ClinicalTrials.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)
Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to 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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Frailty | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation
- description
- Patients receive multi-modal prehabilitation with exercise three times weekly, protein supplements, vitamin supplements, dietitian consultation and medical optimization prior to surgery. A minimum of four weeks.
- interventionNames
- Other: Prehabilitation
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Receives standard of care
Primary outcomes (4)
- measure
- Quality of Recovery 15
- timeFrame
- 3 days after surgery
- description
- Difference in postoperative recovery between baseline and within 3 days after surgery. The cumulative score ranges from 0-150, with a higher value indicating a better outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undergoing elective colorectal cancer surgery * WHO performance status I and II * Signed consent Exclusion Criteria: * Known metastatic disease * Unable to perform baseline test or basic training e.g. paralytic or completely immobilized patients, orthopedic impairments. * ASA 4 or 5 (American Society of Anesthesiologist Classification) * Neoadjuvant chemo- or radiation therapy * Renal failure III B or higher * Illiteracy or unable to write or understand Danish * Cognitive disabilities, which affects adherence e.g. severe dementia (MMSE score ≤17). * Withdrawal of consent.
References
Publications (4)
- DERIVEDBojesen RD, Dalton SO, Skou ST, Jorgensen LB, Walker LR, Eriksen JR, Grube C, Justesen TF, Johansen C, Slooter G, Carli F, Gogenur I. Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial. BJS Open. 2023 Nov 1;7(6):zrad134. doi: 10.1093/bjsopen/zrad134. PMID 38060453
- DERIVEDMolenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3. PMID 37162250
- DERIVEDMolenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2. PMID 35588252
- DERIVEDBojesen RD, Jorgensen LB, Grube C, Skou ST, Johansen C, Dalton SO, Gogenur I. Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Pilot Feasibility Stud. 2022 Jan 21;8(1):11. doi: 10.1186/s40814-022-00967-8. PMID 35063042