An interventional study of Prehabilitation and Immunonutrition and Standard Care Arm in Surgery--Complications, sponsored by Region Skane. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by Region Skane · Not applicable, Interventional, and Prevention
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.
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.
Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard perioperative care is given.
Other: Standard Care Arm
Intervention of prehabilitation and immunonutrition is given prior to surgery
Other: Prehabilitation and Immunonutrition
See study synopsis
Standard care as per the daily routines of the Hospital at which the study takes place
Complications
Severity of postoperative complications according do Clavien-Dindo
Time frame: Assessed when patient is discharged from hospital
Complications
Number of complication(s) according to POMS
Time frame: Assessed at postoperative day 5.
Quality of life with SF-36
Quality of life
Time frame: 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
Time frame: 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)
Time frame: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is not yet recruiting, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Region Skane