Sarcopenia in Colorectal Cancer Patients, Intervention Study

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Recruiting

CT.gov ID

NCT05491434

Collaborator

(none)

370

Enrollment

Location

Arms

27.9

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Postoperative Complications Infection;Post Surg Procedure	Dietary Supplement: Protein supplement	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

370 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

to evaluate the rate of post-surgical infectious complications between the group of sarcopenic and non-sarcopenic patients [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 Outcome Measures

To asess the rate of post-surgical complications between the group of sarcopenic and non-sarcopenic patients [30 days]
All complications, not just infectious
Overall survival at one year [One year]
To study survival one year after surgery in patients considered preoperatively as having sarcopenia.
Quality of life of surgical patients [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.