Multimodal Prehabilitation in Colorectal Cancer Patients

Trial Title: Multimodal Prehabilitation in Colorectal Cancer Patients

NCT ID: NCT06443203

Condition: Colon Cancer
Prehabilitation

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
prehabilitation
colorectal surgery
functional capacity
six-minute walking test
post-operative outcomes

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized controlled clinical trial

Primary purpose: Supportive Care

Masking: Single (Care Provider)

Intervention:

Intervention type: Other
Intervention name: Trimodal prehabilitation
Description: Trimodal prehabilitation program (4-week physical exercise before surgery, nutritional optimization, and psychological support) in patients undergoing ERAS colorectal resection for cancer
Arm group label: Trimodal prehabilitation

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Unità Operativa Qualità, Accreditamento, Ricerca organizzativa

Address:
City: Ferrara
Zip: 44123
Country: Italy

Status: Recruiting

Contact:
Last name: Ilaria IP Panzini, MD

Phone: +390532235548
Email: ilaria.panzini@ausl.fe.it

Investigator:
Last name: Carlo CF Feo, MD FACS
Email: Principal Investigator

Investigator:
Last name: Antonio AP Pesce, MD PhD FACS
Email: Sub-Investigator

Start date: June 15, 2021

Completion date: September 2024

Lead sponsor:
Agency: University Hospital of Ferrara
Agency class: Other

Source: University Hospital of Ferrara

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06443203