Does Prehabilitation Improve Outcome in Coloncancer Surgery?

Surgery--Complications Clinical Trial

— PRIO  

Official title:

The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04199208
• Other study ID #: PRIO01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 7, 2028

Study information

• Verified date: April 2020
• Source: Region Skane
• Contact: Stefan Öberg, MD, PhD
• Phone: +46424061000
• Email: stefan.oberg[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.

Description:

All patients with colon cancer who are intended for curative surgery without neoadjuvant chemotherapy who are >=60 years old will be screened with an ergospirometry. The ones that have a ventilate anaerobic threshold (VAT) of less than 11 mg/ml/kg will be included in the study as they are considered extra frail and have a previously proven high risk for complications. These patients will be randomized to standard care or an intervention of prehabilitation consisting of immunonutrition (protein supplement, multivitamin supplement, Selene etc) and an exercise regimen with 4x1 hours per week of cycling on an ergometer. The exercise regimen will be performed in a group of patients and will be led by a physical therapist to ensure compliance. The resistance of the ergometer will be standardized according to the patient's VAT.

The primary outcome measures will be number of and severity of postoperative complications. Secondary outcome measures include quality of life during prehabilitation with repeated measurements during 5 years after surgery, disease-free survival and overall survival.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 7, 2028
• Est. primary completion date: January 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 years of older

• Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)

• Ventilatory Anaerobic Threshold <11mg/ml/kg

• Planned open or laparoscopic colectomy due to colon cancer

Exclusion Criteria:

• Lower extremity amputee

• Disease requiring radio- and/or chemotherapy prior to surgery/palliative disease

• Distal metastases (Locoregional lymph nodes are OK)

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

Other:
• Prehabilitation and Immunonutrition
See study synopsis
• Standard Care Arm
Standard care as per the daily routines of the Hospital at which the study takes place

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Severity of postoperative complications according do Clavien-Dindo	Assessed when patient is discharged from hospital
Primary	Complications	Number of complication(s) according to POMS	Assessed at postoperative day 5.
Secondary	Quality of life with SF-36	Quality of life	At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery.
Secondary	Disease-free survival	Cancer-free survival Cancer-free survival of the group of the group	30 and 90 days after surgery, 1, 3 and 5 years after surgery.
Secondary	Overall survival	Overall survival of the group (taking all causes of death into account)	30 and 90 days after surgery, 1, 3 and 5 years after surgery.