Sarcopenia in Colorectal Cancer Patients, Intervention Study
Recruiting now · Not applicable
Conditions studied: Sarcopenia, Postoperative Complications, Infection;Post Surg Procedure
In brief
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.
Key facts
- Study ID
- NCT05491434
- Run by
- Hospital Universitari de Bellvitge
- People needed
- 370
- Starts
- 2020-12-01
- Expected to finish
- 2026-01-31
- Last updated by the study team
- 2025-05-20
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 70 years old,
- Colon adenocarcinoma without synchronous metàstasis,
- No urgent surgery,
- ECOG performance status ≤ 2,
- no pregnancy or lactation,
- signature of the informed consent,
- ability to comply with the study indications.
You may not qualify if…
- rectal càncer,
- Concomitant neoplastic disease in the last 5 years
- medical or mental condition of the patient that compromises the authorization of informed consent,
- Concomitant uncontrolled or stable medical condition,
- Clinically significant heart disease (congestive heart failure, symptomatic coronary disease)
- Refusal to participate in the study.
Where it is running
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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