NCT05491434Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- First submitted
- 4 Aug 2022
- Start date
- 1 Dec 2020
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- Colorectal cancer
- NCT number
- NCT05491434
What you commit to
- Study type: Interventional
- Planned participants: 370
- From 1 Dec 2020 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant neoplastic disease in the last 5 years
- Concomitant uncontrolled or stable medical condition,
Other illness
- medical or mental condition of the patient that compromises the authorization of informed consent,
- Clinically significant heart disease (congestive heart failure, symptomatic coronary disease)
Other
- rectal càncer,
- Refusal to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.