Childhood CancerNCT05481229
Nutrition Childhood Cancer Survivors
An observational study of Childhood Cancer and Nutrition Disorders, run by Masaryk University at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Childhood Cancer, Nutrition Disorders
- What is being tested?
- nutritional interventions
- How many people
- 100 participants
- Where
- 2 sitesCzechia
- Study dates
- 25 Apr 2018to 25 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients after treatment from childhood and adolescent cancers.
- The subject is male or female, aged 18 - 64 years
Who cannot join
- Patients with acute cancer therapy
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Masaryk University
Brno, 625 00
Julie Bienertová-Vašků, Prof.
Lucie Štrublová, Mgr.
- Recruiting
St. Anne Hospital in Brno
Brno, 656 91
Tomáš Kepák, MUDr., tomas.kepak@fnusa.cz
Lucie Štrublová, Mgr.
About this study
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
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.
Read the 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
- Conditions
- Childhood Cancer, Nutrition Disorders
- Being tested
- nutritional interventions
- Keywords
- children cancer survivors, adiposity, late effects, nutriton, adipokines
- Medical subject headings
- Neoplasms, Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start25 Apr 2018
- Primary completion25 Apr 2023 (estimated)
- Study completion25 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Julie Bienertová-Vašků, Prof., Principal investigator, Department of Pathological Physiology and RECETOX, Masaryk University, Kamenice 5,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481229
- Sponsor's protocol ID
- NUTRICE CCS BRNO 2017
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strublova L, Kepak T, Kuruczova D, Zlamal F, Holikova M, Kepakova K, Sterba J, Bienertova-Vasku J. Socioeconomic status and adiposity in childhood cancer survivors: A cross-sectional retrospective study. PLoS One. 2024 Feb 16;19(2):e0298068. doi: 10.1371/journal.pone.0298068. eCollection 2024.
PubMed 38363727
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05481229
- Acronym / sponsor ID
- NUTRICE CCS BRNO 2017
- Conditions
- Childhood Cancer, Nutrition Disorders
- Keywords
- children cancer survivors, adiposity, late effects, nutriton, adipokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 25 Apr 2023 (estimated)
- Study completion
- 25 Apr 2023 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Patients after treatment from childhood and adolescent cancers.
- The subject is male or female, aged 18 - 64 years
Key exclusion criteria (2 listed)
- Patients with acute cancer therapy
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional interventionsNutritional 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Determine the prevalence of hight body fat and decreased skeletal muscle.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Derived from this study: PubMed 38363727Strublova L, Kepak T, Kuruczova D, Zlamal F, Holikova M, Kepakova K, Sterba J, Bienertova-Vasku J. Socioeconomic status and adiposity in childhood cancer survivors: A cross-sectional retrospective study. PLoS One. 2024 Feb 16;19(2):e0298068. doi: 10.1371/journal.pone.0298068. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Bienertová-Vašků, Prof. principal investigator
Department of Pathological Physiology and RECETOX, Masaryk University, Kamenice 5,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Nutrition Disorders, run by Masaryk University at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomáš Kepák, MUDr. (+420724333969, tomas.kepak@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the relationship between the levels of adipokines and cardiometabolic diseases. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.