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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Sarcopenia; Infection;Post Surg Procedure
• Intervention / Treatment: Dietary supplement: Protein supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 370
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo Frago, Ph D; Phone Number: +34932607485; Email: rfrago@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08709
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Ricardo Frago, Ph D; Phone Number: +34932607485; Email: rfrago@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; One líquid brick every day during 3 weeks; Other Names: 10gr protein/100 ml. Every liquid brick have 200 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To asess the rate of post-surgical complications between the group of sarcopenic and non-sarcopenic patients	All complications, not just infectious	30 days
Overall survival at one year	To study survival one year after surgery in patients considered preoperatively as having sarcopenia.	One year
Quality of life of surgical patients	Evaluate the quality of life according the QLQ EORTC QlQ C-30 y ClQ CR29	At 3 months, 6 months and one year after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative complications; Sarcopenia; Colon cancer; Inmunologic status; L3 CT image
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Postoperative Complications
• Other Study ID Numbers: PR137/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No