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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05481229
Other study ID # NUTRICE CCS BRNO 2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 25, 2018
Est. completion date April 25, 2023

Study information

Verified date July 2022
Source Masaryk University
Contact Tomáลก Kepák, MUDr.
Phone +420724333969
Email tomas.kepak@fnusa.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

NUTRITION CCS is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission. The study was conducted in the Clinic for childhood cancer survivors. The clinic is attended by patients older than 18 years and was built in 2016 at the St. Anne's Hospital in Brno.


Description:

NUTRITION CCS is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission. Objectives of the study 1. to determine the prevalence (incidence) of nutritional disorders, especially obesity and metabolic syndrome, in cured paediatric cancer patients in adulthood; 2. to investigate the role of adipokines in the development of cardiometabolic complications in this group of patients; 3. to determine whether targeted dietary and lifestyle interventions can lead to improvements in nutritional status and subjectively perceived quality of life of treated paediatric cancer patients in adulthood and objectively assessed cardiometabolic risk


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 25, 2023
Est. primary completion date April 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Patients after treatment from childhood and adolescent cancers. - The subject is male or female, aged 18 - 64 years Exclusion Criteria: - Patients with acute cancer therapy - Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
nutritional interventions
Nutritional intervention will be initiated in patients at risk of overweight and obesity. A targeted nutritional intervention will be carried out, which will include consultation on dietary habits and physical activity as determined by diet and physical activity records. Consultations will be aimed at improving lifestyle and maintaining an adequate body weight.

Locations

Country Name City State
Czechia Masaryk University Brno
Czechia St. Anne Hospital in Brno Brno

Sponsors (2)

Lead Sponsor Collaborator
Masaryk University St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Define the relationship between the levels of adipokines and cardiometabolic diseases. Define the relationship between the levels of selected adipokines and the risk of selected chronic diseases, specifically cardiometabolic diseases. through study completion, an average of 1 year
Secondary Determine the prevalence of hight body fat and decreased skeletal muscle. Determine the number of patients with a high body fat percentage. In these patients, monitor the responses of selected adipokine levels to targeted nutritional intervention leading to fat mass reduction. through study completion, an average of 1 year
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