Prehabilitation in Rectal Cancer: During Neoadjuvant Therapy vs Preoperative
PREHAREC
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.
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Typical duration 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
First Submitted
Initial submission to the registry
February 9, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 18, 2022
March 1, 2022
Same day
February 9, 2022
March 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comprehension Complication Index (CCI)
Morbidity after surgery of rectal cancer: CCI - value 0-100
through study completion, an average of 1 yea
Secondary Outcomes (2)
6 minutes walking test (6MWT)
through study completion, an average of 1 yea
Hospital Anxiety and Depression Scale (HADS) test : anxious and depresion scale
through study completion, an average of 1 yea
Study Arms (2)
PREHAB-PREOP
SHAM COMPARATORPREHABILITATION BEFORE SURGERY
PREHAB-NEOADJ
EXPERIMENTALPREHABILITATION DURING NEOADJUVANCY AND BEFORE SURGERY
Interventions
Control of the physical, nutritional and psychological preparation of the patient who will undergo rectal cancer surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laura Mora López
Sabadell, Barcelona, 08208, Spain
Related Publications (6)
Berho 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: 25629513RESULTHerman 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: 23058059RESULTPramateftakis 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: 23008766RESULTGillis 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: 30025745RESULTWright 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: 27536795RESULTSanta 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: 33505914RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Mora, Dr
Parc Tauli University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- due to the characteristics of the study, it is not possible to perform masking
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD, Colorrectal Surgeon, Associate Professor
Study Record Dates
First Submitted
February 9, 2022
First Posted
March 18, 2022
Study Start
March 1, 2022
Primary Completion
March 1, 2022
Study Completion
March 1, 2025
Last Updated
March 18, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share