Multimodal Prehabilitation in Colorectal Cancer Patients

Colon Cancer Clinical Trial

Official title:

A Randomized Controlled Clinical Trial on Multimodal Prehabilitation in Colorectal Cancer Patients to Improve Functional Capacity and Lower Postoperative Complications.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443203
• Other study ID #: 849/2019/Sper/AUSLFe
• Secondary ID: RF-2018- 1236727
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: University Hospital of Ferrara
• Contact: CARLO CF FEO, MD FACS
• Phone: +39 3282198106
• Email: fcl[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study aims to determine the effect of prehabilitation on patients' functional capacity and postoperative complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation (N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS) guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients of age >18 years;

• elective colorectal resection for colonic cancer.

Exclusion Criteria:

• metastatic disease;

• severe walking impairments;

• renal failure stage >2;

• ASA score >3;

• preoperative chemo-radiation therapy.

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms
• Prehabilitation

Intervention

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

Locations

Country	Name	City	State
Italy	Unità Operativa Qualità, Accreditamento, Ricerca organizzativa	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA Surg. 2023 May 3;: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative complications	To evaluate post-operative complications, the Clavien-Dindo classification has been used as a combined measure of morbidity and mortality.	Within 30 days after surgery
Secondary	Hospital length of stay	To evaluate the length of postoperative hospital stay	Within 30 days after surgery