Does Prehabilitation Improve Outcome in Coloncancer Surgery? (PRIO)

Region Skane

Status: Not yet enrolling

Conditions: Surgery--Complications

Treatments: Other: Prehabilitation and Immunonutrition; Other: Standard Care Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04199208

PRIO01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Standard Care Arm

Active Comparator group

Description:

Standard perioperative care is given.

Treatment:

Other: Standard Care Arm

Interventional Arm

Experimental group

Description:

Intervention of prehabilitation and immunonutrition is given prior to surgery

Treatment:

Other: Prehabilitation and Immunonutrition