Sarcopenia in Colorectal Cancer Patients, Intervention Study

Trial Title: Sarcopenia in Colorectal Cancer Patients, Intervention Study

NCT ID: NCT05491434

Condition: Sarcopenia
Postoperative Complications
Infection;Post Surg Procedure

Conditions: Official terms:
Sarcopenia
Postoperative Complications

Conditions: Keywords:
Sarcopenia
Colon cancer
Postoperative complications
Inmunologic status
L3 CT image

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Protein supplement
Description: One líquid brick every day during 3 weeks
Arm group label: Experimental

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

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.

Criteria for 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.

Gender: All

Minimum age: 70 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Universitari de Bellvitge

Address:
City: L'Hospitalet De Llobregat
Zip: 08709
Country: Spain

Status: Recruiting

Contact:
Last name: Ricardo Frago, Ph D

Phone: +34932607485
Email: rfrago@bellvitgehospital.cat

Start date: December 1, 2020

Completion date: December 31, 2024

Lead sponsor:
Agency: Hospital Universitari de Bellvitge
Agency class: Other

Source: Hospital Universitari de Bellvitge

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05491434