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

Completed

• Conditions: Childhood Cancer

• Registration Number: NCT04815447
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-20
• Status Verified: 2021-03
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of VO2max for CCS patients compared to control children	1 day	comparison of the mean of VO2max value in ml/kg/min between CCS group and control group

Secondary Outcome Measures

Name	Time	Method
correlation between clinical determinants and VO2max in the CCS group	1 day	with multivariate analysis, we will look for the correlation between the clinical determinants and the decreased of VO2max in CCS group.
comparison of ventilatory anaerobic threshold (VAT) for CCS patients compared to control children	1 day	comparison of the mean of VAT value in ml/kg/min between CCS group and control group

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France