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NCT Number: NCT05491434

Sarcopenia in Colorectal Cancer Patients, Intervention Study

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.

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Key information

Conditions

Sarcopenia Atrophy Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Infection;Post Surg Procedure Intestinal Diseases Intestinal Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08709, Spain

Location status: Recruiting

Location contact

Ricardo Frago, Ph D

CONTACT

[email protected]

+34932607485

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein Supplement

Dietary Supplement

One líquid brick every day during 3 weeks

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

Primary outcomes

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

    Time frame: 30 days

    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

Secondary outcomes

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

    Time frame: 30 days

    All complications, not just infectious

  2. Overall survival at one year

    Time frame: One year

    To study survival one year after surgery in patients considered preoperatively as having sarcopenia.

  3. Quality of life of surgical patients

    Time frame: At 3 months, 6 months and one year after surgery

    Evaluate the quality of life according the QLQ EORTC QlQ C-30 y ClQ CR29

Study contacts

Contact information is provided by the study sponsor or research team.

Ricardo Frago, Ph D

CONTACT

[email protected]

+34932607485

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Intervention, Non-randomized Controlled, Non-masked and Comparative Study of Presurgical Conditioning in Colorectal Cancer Patients Who Present With Sarcopenia

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Aug 8, 2022
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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