NCT05491434 Sarcopenia in Colorectal Cancer Patients, Intervention Study
| NCT ID | NCT05491434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari de Bellvitge |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 370 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 370 participants in total. It began in 2020-12-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05491434 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05491434 currently recruiting?
Yes, NCT05491434 is actively recruiting participants. Contact the research team at rfrago@bellvitgehospital.cat for enrollment information.
Where is the NCT05491434 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain.
Who is sponsoring the NCT05491434 clinical trial?
NCT05491434 is sponsored by Hospital Universitari de Bellvitge. The trial plans to enroll 370 participants.