Does Prehabilitation Improve Outcome in Coloncancer Surgery?

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery--Complications

Intervention / Treatment
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* Other: Prehabilitation and Immunonutrition
* Other: Standard Care Arm


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized two-armed clinical trial
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise therapy, perioperative period, coloncancer