Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infection;Post Surg Procedure | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protein supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- The usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity
- type
- EXPERIMENTAL
- label
- Experimental
- description
- In addition to the usual pre-surgical preparation and conditioning, a nutritional supplement and increased physical activity will be provided in a controlled manner for 3 weeks.
- interventionNames
- Dietary Supplement: Protein supplement
Primary outcomes (1)
- measure
- to evaluate the rate of post-surgical infectious complications between the group of sarcopenic and non-sarcopenic patients
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available