Cardiopulmonary Fitness and Its Clinical Determinants of a Population of Childhood Cancer Survivor (ONCO-SPORT)

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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Cancer

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uh Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• CCS having been complete a full regimen for oncological disease and considered in remission at the end of treatment
• Controlled children with completely normal check-up, including physical examination, ECG, echocardiography and spirometry

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CCS group; Patients under 25 were recruited in the pediatric CPET laboratory of Montpellier University Hospital after a regular paediatric cardiology outpatient visit.
Control; The control group consisted in children referred for a non-severe functional symptom linked to exercise (murmur, palpitation, or dyspnoea) or for a medical sports certificate. These children were classified in the control group only after a completely normal check-up, including physical examination, electrocardiogram, echocardiography, and spirometry.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Pediatric Oncology Department, Montpellier University Hospital, France; Pediatric and Congenital Cardiology Department, Montpellier University Hospital, France
• Investigators: Principal Investigator: Arthur GAVOTTO, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 20, 2021

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: childhood cancer survivors; Radiotherapy; VO2max; Cardio-pulmonary exercise test; Ventilatory anaerobis threshold; Hematopoietic stem cells transplantation
• Other Study ID Numbers: RECHMPL20_0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No