RecruitingNot ApplicableNCT05491434

Sarcopenia in Colorectal Cancer Patients, Intervention Study

Intervention, Non-randomized Controlled, Non-masked and Comparative Study of Presurgical Conditioning in Colorectal Cancer Patients Who Present With Sarcopenia


Sponsor

Hospital Universitari de Bellvitge

Enrollment

370 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The sarcopenia is a new concept for evaluating the functional status of patients, introduced during the last 20 years. This is defined as the relationship between the deterioration of muscle mass and the decrease in strength, the metabolic rate, the aerobic capacity and subsequently the evaluation of the functional status. The sarcopenia has been estimated to affect 5% to 13% of people aged between 60 and 70 years, increasing from 11% to 50% in those aged 80 years and older. In a study by Lieffers et al. of a total of 234 patients with colorectal cancer, with a mean age of 63 years according to the values observed by Prado et al., the prevalence of sarcopenia would be around 39%, being able to reach up to 60% in patients with chronic diseases. The goal of this study is to compare the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise.


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a nutrition and exercise program to address sarcopenia — the loss of muscle mass and strength — in older patients with colon cancer before they undergo surgery. Researchers want to see if improving muscle health before the operation leads to better surgical outcomes. **You may be eligible if...** - You are 70 years old or older - You have been diagnosed with colon adenocarcinoma without distant spread (no metastasis) - Your surgery is planned (not an emergency) - You are in reasonable health (ECOG performance status 0–2) - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have rectal cancer (as opposed to colon cancer) - You have had another cancer in the past 5 years - You have a serious uncontrolled medical or mental health condition - You have clinically significant heart disease - You refuse to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProtein supplement

One líquid brick every day during 3 weeks


Locations(1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

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NCT05491434


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