Surgery--Complications
Conditions
Keywords
exercise therapy, perioperative period, coloncancer
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.
Interventions
OTHERPrehabilitation and Immunonutrition
See study synopsis
OTHERStandard Care Arm
Standard care as per the daily routines of the Hospital at which the study takes place
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized two-armed clinical trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | Assessed when patient is discharged from hospital | Severity of postoperative complications according do Clavien-Dindo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life with SF-36 | 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. | Quality of life |
| Disease-free survival | 30 and 90 days after surgery, 1, 3 and 5 years after surgery. | Cancer-free survival Cancer-free survival of the group of the group |
| Overall survival | 30 and 90 days after surgery, 1, 3 and 5 years after surgery. | Overall survival of the group (taking all causes of death into account) |
Contacts
Primary ContactStefan Öberg, MD, PhD
Outcome results
None listed