- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481229
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
- 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 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
- Name: Tomáš Kepák, MUDr.
- Phone Number: +420724333969
- Email: tomas.kepak@fnusa.cz
Study Contact Backup
- Name: Lucie Štrublová, Mgr.
- Phone Number: +420728608476
- Email: luciestrubl@gmail.com
Study Locations
-
-
-
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:
- Tomáš Kepák, MUDr.
- Email: tomas.kepak@fnusa.cz
-
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
Collaborators
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
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.