Multimodal Prehabilitation in Colorectal Cancer Patients

NCT06443203 | Active Not Recruiting DMC

• 2 other identifiers: 849/2019/Sper/AUSLFeRF-2018- 12367272
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. Even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. Many of these negative effects can be decreased by applying specific ERAS (Enhanced Recovery After Surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients\' post-operative convalescence and facilitate their return to functional activities. In this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.

Conditions

Colon Cancer; Prehabilitation

Keywords

prehabilitation; colorectal surgery; functional capacity; six-minute walking test; post-operative outcomes

Outcome Measures

Primary Outcomes (1)

• Postoperative functional capacity

  The primary outcome for functional capacity was measured by the 6-Minute Walking Test (6MWT), chosen as a validated, objective measure of colorectal surgery recovery integrating all components of physical activity.

  From enrollment to the end of treatment at 8 weeks after surgery

Secondary Outcomes (2)

• Post-operative complications

  Within 30 days after surgery

• Hospital length of stay

  Within 30 days after surgery

Study Arms (2)

Trimodal prehabilitation

EXPERIMENTAL

physical exercise, psychological support and nutritional optimization 4-weeks before surgery

Other: Trimodal prehabilitation

control group without preoperative prehabilitation

NO INTERVENTION

Patients no receiveing prehabilitation and undergoing standard rehabilitation alone after surgery

Interventions

Trimodal prehabilitation OTHER

Trimodal prehabilitation program (4-week physical exercise before surgery, nutritional optimization, and psychological support) in patients undergoing ERAS colorectal resection for cancer

Trimodal prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of age \>18 years;
• elective colorectal resection for colonic cancer.

You may not qualify if:

• metastatic disease;
• severe walking impairments;
• renal failure stage \>2;
• ASA score \>3;
• preoperative chemo-radiation therapy.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Unità Operativa Qualità, Accreditamento, Ricerca organizzativa

Ferrara, 44123, Italy

Location

Related Publications (4)

• Bojesen 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 BACKGROUND

• Molenaar CJL, Minnella EM, Coca-Martinez M, Ten Cate DWG, Regis M, Awasthi R, Martinez-Palli G, Lopez-Baamonde M, Sebio-Garcia R, Feo CV, van Rooijen SJ, Schreinemakers JMJ, Bojesen RD, Gogenur I, van den Heuvel ER, Carli F, Slooter GD; PREHAB Study Group. Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial. JAMA Surg. 2023 Jun 1;158(6):572-581. doi: 10.1001/jamasurg.2023.0198.

  PMID: 36988937 BACKGROUND

• Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.

  PMID: 20602503 BACKGROUND

• Gillis 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 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Carlo CF Feo, MD FACS

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 5, 2024
• Study Start: June 15, 2021
• Primary Completion: June 2, 2025
• Study Completion: April 2, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)