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

NCT ID: NCT04815447

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-02-20

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.

Conditions

Childhood Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CCS group

Patients under 25 were recruited in the pediatric CPET laboratory of Montpellier University Hospital after a regular paediatric cardiology outpatient visit.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Oncology Department, Montpellier University Hospital, France

UNKNOWN

Sponsor Role: collaborator

Pediatric and Congenital Cardiology Department, Montpellier University Hospital, France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal AMEDRO, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Arthur GAVOTTO

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uh Montpellier

Montpellier, , France

Countries

France

References

Gavotto A, Dubard V, Avesani M, Huguet H, Picot MC, Abassi H, Guillaumont S, De La Villeon G, Haouy S, Sirvent N, Sirvent A, Theron A, Requirand A, Matecki S, Amedro P. Impaired aerobic capacity in adolescents and young adults after treatment for cancer or non-malignant haematological disease. Pediatr Res. 2023 Aug;94(2):626-631. doi: 10.1038/s41390-023-02477-6. Epub 2023 Jan 28.

Reference Type: DERIVED

PMID: 36709386 (View on PubMed)

Other Identifiers

RECHMPL20_0089

Identifier Type: -

Identifier Source: org_study_id