Sarcopenia in Colorectal Cancer Patients, Intervention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorHospital Universitari de Bellvitge
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 70 years old,
Colon adenocarcinoma without synchronous metàstasis,
No urgent surgery,
ECOG performance status ≤ 2,
Disqualifiers
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,
Trial design
Design model
Crossover
Treatments tested in this trial
Protein supplement
Dietary supplementOne líquid brick every day during 3 weeks
Treatment groups
370 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
30 daysSecondary outcomes
1
To asess the rate of post-surgical complications between the group of sarcopenic and non-sarcopenic patients
All complications, not just infectious
Time frame
30 days2
Overall survival at one year
To study survival one year after surgery in patients considered preoperatively as having sarcopenia.
Time frame
One year3
Quality of life of surgical patients
Evaluate the quality of life according the QLQ EORTC QlQ C-30 y ClQ CR29
Time frame
At 3 months, 6 months and one year after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov