Nutrition Childhood Cancer Survivors

Sponsor

Masaryk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05481229

Collaborator

St. Anne's University Hospital Brno, Czech Republic (Other)

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer Nutrition Disorders	Other: nutritional interventions

Detailed Description

Objectives of the study

to determine the prevalence (incidence) of nutritional disorders, especially obesity and metabolic syndrome, in cured paediatric cancer patients in adulthood;
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

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 25, 2018

Anticipated Primary Completion Date :

Apr 25, 2023

Anticipated Study Completion Date :

Apr 25, 2023

Outcome Measures

Primary Outcome Measures

Define the relationship between the levels of adipokines and cardiometabolic diseases. [through study completion, an average of 1 year]
Define the relationship between the levels of selected adipokines and the risk of selected chronic diseases, specifically cardiometabolic diseases.

Secondary Outcome Measures

Determine the prevalence of hight body fat and decreased skeletal muscle. [through study completion, an average of 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masaryk University	Brno		Czechia	625 00
2	St. Anne Hospital in Brno	Brno		Czechia	656 91

Sponsors and Collaborators

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

Investigators

Principal Investigator: Julie Bienertová-Vašků, Prof., Department of Pathological Physiology and RECETOX, Masaryk University, Kamenice 5,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Masaryk University

ClinicalTrials.gov Identifier:

NCT05481229

Other Study ID Numbers:

NUTRICE CCS BRNO 2017

First Posted:

Aug 1, 2022

Last Update Posted:

Aug 1, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Masaryk University

children cancer survivors

Additional relevant MeSH terms:

Nutrition Disorders

Study Results

No Results Posted as of Aug 1, 2022