Clinical trial · Interventional
Prehabilitation in Rectal Cancer: During Neoadjuvant Therapy vs Preoperative
Randomized Controlled Trial Comparing the Effect of a Multimodal Prehabilitation Program During Neoadjuvant Treatment Versus a Multimodal Prehabilitation After Neoadjuvant Treatment for Patients Undergoing Resection of Rectal Cancer.
NCT05286086CI-TRIAL-00057208PREHARECunknownN/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)
Control of the effect of prehabilitation on postoperative morbidity, assessed by the Comprehensive Complication Index (CCI), in patients diagnosed with rectal cancer that will receive neoadjuvant Quimiorradiotherapy (NCRT) and subsequent surgery, performed at the beginning of NCRT or before surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Rectal Cancer, Adenocarcinoma | Malignant Rectal Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- PREHAB-PREOP
- description
- PREHABILITATION BEFORE SURGERY
- interventionNames
- Behavioral: prehabilitation
- type
- EXPERIMENTAL
- label
- PREHAB-NEOADJ
- description
- PREHABILITATION DURING NEOADJUVANCY AND BEFORE SURGERY
- interventionNames
- Behavioral: prehabilitation
Primary outcomes (1)
- measure
- Comprehension Complication Index (CCI)
- timeFrame
- through study completion, an average of 1 yea
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with rectal tumour and selected to initiate NRCT * Patient must know the study and sign informed consent. * Patient must accept the conditions necessaries to carry out the prehabilitation. Exclusion Criteria: * Refusal of the patient to sign the informed consent. * Baseline pathology that makes it impossible to carry out prehabilitation. * Progression of the disease during the study period. * Emergency surgery.
References
Publications (6)
- RESULTBerho M, Narang R, Van Koughnett JA, Wexner SD. Modern multidisciplinary perioperative management of rectal cancer. JAMA Surg. 2015 Mar 1;150(3):260-6. doi: 10.1001/jamasurg.2014.2887. PMID 25629513
- RESULTHerman JM, Narang AK, Griffith KA, Zalupski MM, Reese JB, Gearhart SL, Azad NS, Chan J, Olsen L, Efron JE, Lawrence TS, Ben-Josef E. The quality-of-life effects of neoadjuvant chemoradiation in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):e15-9. doi: 10.1016/j.ijrobp.2012.09.006. Epub 2012 Oct 9. PMID 23058059
- RESULTPramateftakis MG, Kanellos D, Tekkis PP, Touroutoglou N, Kanellos I. Rectal cancer: multimodal treatment approach. Int J Surg Oncol. 2012;2012:279341. doi: 10.1155/2012/279341. Epub 2012 Sep 12. No abstract available. PMID 23008766
- RESULTGillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9. PMID 30025745
- RESULTWright S, Wiechula R, McLiesh P. The effectiveness of prehabilitation for adults having elective surgery: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Feb;14(2):78-92. doi: 10.11124/jbisrir-2016-2460. No abstract available. PMID 27536795
- RESULTSanta Mina D, van Rooijen SJ, Minnella EM, Alibhai SMH, Brahmbhatt P, Dalton SO, Gillis C, Grocott MPW, Howell D, Randall IM, Sabiston CM, Silver JK, Slooter G, West M, Jack S, Carli F. Multiphasic Prehabilitation Across the Cancer Continuum: A Narrative Review and Conceptual Framework. Front Oncol. 2021 Jan 11;10:598425. doi: 10.3389/fonc.2020.598425. eCollection 2020. PMID 33505914