Does Prehabilitation Improve Outcome in Coloncancer Surgery?

NCT ID: NCT04199208

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2028-01-07

Brief 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.

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.

Conditions

Surgery--Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Standard Care Arm

Standard perioperative care is given.

Group Type: ACTIVE_COMPARATOR

Standard Care Arm

Intervention Type: OTHER

Standard care as per the daily routines of the Hospital at which the study takes place

Interventional Arm

Intervention of prehabilitation and immunonutrition is given prior to surgery

Group Type: EXPERIMENTAL

Prehabilitation and Immunonutrition

Intervention Type: OTHER

See study synopsis

Interventions

Prehabilitation and Immunonutrition

See study synopsis

Intervention Type: OTHER

Standard Care Arm

Standard care as per the daily routines of the Hospital at which the study takes place

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Öberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne/Lund University

Central Contacts

Stefan Öberg, MD, PhD

Role: CONTACT

stefan.oberg@med.lu.se

+46424061000

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRIO01

Identifier Type: -

Identifier Source: org_study_id