Does Prehabilitation Improve Outcome in Coloncancer Surgery? (PRIO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery--Complications
• Intervention / Treatment: Other: Standard Care Arm; Other: Prehabilitation and Immunonutrition

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Öberg, MD, PhD; Phone Number: +46424061000; Email: stefan.oberg@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care Arm; Standard perioperative care is given.	Other: Standard Care Arm; Standard care as per the daily routines of the Hospital at which the study takes place
Experimental: Interventional Arm; Intervention of prehabilitation and immunonutrition is given prior to surgery	Other: Prehabilitation and Immunonutrition; See study synopsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Severity of postoperative complications according do Clavien-Dindo	Assessed when patient is discharged from hospital
Complications	Number of complication(s) according to POMS	Assessed at postoperative day 5.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Stefan Öberg, MD, PhD, Region Skåne/Lund University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): January 7, 2023
• Study Completion (Anticipated): January 7, 2028

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: exercise therapy; perioperative period; coloncancer
• Other Study ID Numbers: PRIO01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No