Sarcopenia in Colorectal Cancer Patients, Intervention Study

NCT ID: NCT05491434

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2026-01-31

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.

Detailed Description

CONCEPTUAL HYPOTHESIS Improving functional status through physical exercise and nutritional supplementation of sarcopenic colon cancer patients at diagnosis can reduce the rate of infectious complications after surgery.

OPERATIONAL HYPOTHESIS Active preoperative preparation of sarcopenic colon cancer patients reduces post-surgical infectious complications by at least 11%, reaching a rate similar to patients without initial sarcopenia.

Inclusion criteria: - Age ≥ 70 years old; - Colon adenocarcinoma without synchronous metastases; - 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 cancer; - 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.

Study variable (categorization of patients): Evaluation of Sarcopenia: it will be performed by CT, identifying the image of L3 (3rd lumbar vertebra). Main outcome variable: Cumulative incidence of post-surgical complications due to infection at 30 days.

Secondary variables: Frailty, Immune status, Quality of life (QoL) C30 and CR29 INTRVENTION (study groups)

• ARM A (Control: No sarcopenia): the usual pre-surgical preparation and conditioning will be carried out, without providing nutritional supplements or increased physical activity.
• ARM B (Experimental: Sarcopenia): 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.

Conditions

Sarcopenia; Postoperative Complications; Infection;Post Surg Procedure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Protein supplement

Intervention Type: DIETARY_SUPPLEMENT

One líquid brick every day during 3 weeks

Interventions

Protein supplement

One líquid brick every day during 3 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

10gr protein/100 ml. Every liquid brick have 200 ml

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Frago Montanuy

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ricardo Frago, Ph D

Role: CONTACT

rfrago@bellvitgehospital.cat

+34932607485

Facility Contacts

Ricardo Frago, Ph D

Role: primary

rfrago@bellvitgehospital.cat

+34932607485

Other Identifiers

PR137/19

Identifier Type: -

Identifier Source: org_study_id