Nutrition Childhood Cancer Survivors

July 28, 2022 updated by: Masaryk University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • Masaryk university
        • Contact:
          • Julie Bienertová-Vašků, Prof.
        • Sub-Investigator:
          • Lucie Štrublová, Mgr.
        • Sub-Investigator:
          • Jan Kučera, Ph.D.
      • Brno, Czechia, 656 91
        • Recruiting
        • St. Anne Hospital in Brno
        • Sub-Investigator:
          • Lucie Štrublová, Mgr.
        • Contact:
        • Sub-Investigator:
          • Viera Bajčiová, MUDr.
        • Sub-Investigator:
          • Hana Hrstková, Prof.
        • Sub-Investigator:
          • Jaroslav Štěrba, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population is patients who have been treated for childhood or adolescent cancer and who are now being followed up in a dispensary clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define the relationship between the levels of adipokines and cardiometabolic diseases.
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the prevalence of hight body fat and decreased skeletal muscle.
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2018

Primary Completion (ANTICIPATED)

April 25, 2023

Study Completion (ANTICIPATED)

April 25, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (ACTUAL)

August 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTRICE CCS BRNO 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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