Sarcopenia in Colorectal Cancer Patients, Intervention Study

NCT05491434 | Recruiting

• 1 other identifier: PR137/19
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Postoperative Complications; Infection;Post Surg Procedure

Keywords

Sarcopenia; Colon cancer; Postoperative complications; Inmunologic status; L3 CT image

Outcome Measures

Primary Outcomes (1)

• to evaluate the rate of post-surgical infectious complications between the group of sarcopenic and non-sarcopenic patients

  Evaluate 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 in the latter group

  30 days

Secondary Outcomes (3)

• To asess the rate of post-surgical complications between the group of sarcopenic and non-sarcopenic patients

  30 days

• Overall survival at one year

  One year

• Quality of life of surgical patients

  At 3 months, 6 months and one year after surgery

Study Arms (2)

Control

NO INTERVENTION

The usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity

Experimental

EXPERIMENTAL

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.

Dietary Supplement: Protein supplement

Interventions

Protein supplement DIETARY_SUPPLEMENT

One líquid brick every day during 3 weeks

Also known as: 10gr protein/100 ml. Every liquid brick have 200 ml

Experimental

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08709, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Postoperative Complications; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Ricardo Frago, Ph D

CONTACT

+34932607485; rfrago@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: December 1, 2020
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

ES (1)