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Cardiopulmonary Fitness and Its Clinical Determinants of a Population of Childhood Cancer Survivor

Cardiopulmonary Fitness and Its Clinical Determinants of a Population of Childhood Cancer Survivor: a Controlled Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04815447
Acronym
ONCO-SPORT
Enrollment
500
Registered
2021-03-25
Start date
2020-03-01
Completion date
2021-02-20
Last updated
2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Cancer

Keywords

childhood cancer survivors, VO2max, Ventilatory anaerobis threshold, Cardio-pulmonary exercise test, Hematopoietic stem cells transplantation, Radiotherapy

Brief summary

Medical progress have made it possible to considerably improve the survival of children with an oncological disease. Currently, the survival rate increased to above 90 % in the most developed countries . This increase of childhood cancer survivors (CCS) asks us about their future and their quality of life. Assessing health related life quality , previous studies observe that in this particular population of patients, it is related to a poor physical capacity , physical activity level and many of these patients do not meet the activity level recommended by the world health organization due to fatigability and sedentary behaviours . In addition to these habits, the CCS are more susceptible to develop cardiovascular risk (CVR) leading to cardiovascular disease in adulthood and increases them mortality . Furthermore, CCS who have been experiencing hematopoietic stem cells transplantation (HSCT) are more susceptible to develop these CVR. In parallel with the common CVR, lower cardiopulmonary fitness assessed by cardiopulmonary exercise test (CPET) in the general population has been established as a major and independent CVR for cardiologic events. Cardiopulmonary fitness assessed by maximal cardiopulmonary exercise test (CPET) allows physicians to measure metabolic response to maximal effort in a population that is known as VO2max. This domain of applied physiology permits a new way to approach the understanding of global health prognosis in chronic disease. For example, decrease of VO2max is involved in lower quality of life in patients with congenital heart disease. Cardiopulmonary exercise test for VO2max exploration has been demonstrated feasible in child patients with leukemia or other tumors after intensive chemotherapy, prior to HSCT. Assessment of cardiopulmonary fitness in CCS is already described in previous studies, but this study aimed to compare a maximal CPET assessment on a large childhood cancer survivors cohort with healthy control, on a quite young cohort, during the oncologic follow up and find out its determinants.

Detailed description

This is a controlled, monocentric, cross-sectional study conducted in a tertiary care center for oncologic disease in children (Montpellier University Hospital, France) was carried out between November 2010 and November 2020. Two groups were identified: CCS group and control group.

Interventions

None listed

Sponsors

Pediatric Oncology Department, Montpellier University Hospital, France
CollaboratorUNKNOWN
Pediatric and Congenital Cardiology Department, Montpellier University Hospital, France
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

for CCS group : * aged between 5 and 25 years old, * having been complete a full regimen for oncological disease and considered in remission at the end of treatment. Remission was considered in absence of relapse or new treatment initiated before the CPET end point. Inclusion criteria for control group : * children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate. * completely normal check-up, including physical examination, ECG, echocardiography and spirometry.

Exclusion criteria

for control group: * Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal) * Children with any medical treatment * Children requiring any further specialised medical consultation

Design outcomes

Primary

MeasureTime frameDescription
comparison of VO2max for CCS patients compared to control children1 daycomparison of the mean of VO2max value in ml/kg/min between CCS group and control group

Secondary

MeasureTime frameDescription
comparison of ventilatory anaerobic threshold (VAT) for CCS patients compared to control children1 daycomparison of the mean of VAT value in ml/kg/min between CCS group and control group
correlation between clinical determinants and VO2max in the CCS group1 daywith multivariate analysis, we will look for the correlation between the clinical determinants and the decreased of VO2max in CCS group.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026