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

Inclusion Criteria7

  • 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 Criteria6

  • 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.

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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