Prehabilitation and Immunonutrition
OtherSee study synopsis
NCT Number: NCT04199208
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See study synopsis
Standard care as per the daily routines of the Hospital at which the study takes place
Time frame: Assessed when patient is discharged from hospital
Severity of postoperative complications according do Clavien-Dindo
Time frame: Assessed at postoperative day 5.
Number of complication(s) according to POMS
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.
Quality of life
Time frame: 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
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Region Skane
Other
The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study
Acronym: PRIO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04430972
Aortic Valve Disease, Cardiovascular Diseases
London, United Kingdom
View Trial DetailsNCT04168346
Anemia, Anemia, Hypochromic
View Trial DetailsNCT04367987
Surgery--Complications
Nîmes, France
View Trial DetailsNCT04197271
Disease Attributes, Emergencies
Sheffield, South Yorkshire, United Kingdom
View Trial Details