Nutrition Childhood Cancer Survivors

Childhood Cancer Clinical Trial

Official title:

Nutritional Status of Cured Pediatric Cancer Patients in Adulthood, the Role of Adipokines in the Development of Cardiometabolic Complications and Desirable Nutritional Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481229
• Other study ID #: NUTRICE CCS BRNO 2017
• Status: Recruiting
• Start date: April 25, 2018
• Est. completion date: April 25, 2023

Study information

• Verified date: July 2022
• Source: Masaryk University
• Contact: Tomáš Kepák, MUDr.
• Phone: +420724333969
• Email: tomas.kepak[@]fnusa.cz
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Childhood Cancer
• Nutrition Disorders

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