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

NCT04815447 | Completed

• 1 other identifier: RECHMPL20_0089
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• comparison of ventilatory anaerobic threshold (VAT) for CCS patients compared to control children

  1 day

• correlation between clinical determinants and VO2max in the CCS group

  1 day

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Pediatric Oncology Department, Montpellier University Hospital, France: collaborator
• Pediatric and Congenital Cardiology Department, Montpellier University Hospital, France: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 36709386 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Pascal AMEDRO, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

• Arthur GAVOTTO

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: March 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 20, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-03

Locations

FR (1)