Sarcopenia in Colorectal Cancer Patients, Intervention Study

Official title

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

Overview

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.

Interventions

• Dietary supplement Protein supplement
  One líquid brick every day during 3 weeks

Primary outcome measures

• to evaluate the rate of post-surgical infectious complications between the group of sarcopenic and non-sarcopenic patients [Time frame: 30 days]

Secondary outcome measures (3)

• To asess the rate of post-surgical complications between the group of sarcopenic and non-sarcopenic patients [Time frame: 30 days]
• Overall survival at one year [Time frame: One year]
• Quality of life of surgical patients [Time frame: At 3 months, 6 months and one year after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

Spain · 1 center

• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Identifiers

NCT: NCT05491434 · PR137/19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗