Childhood CancerONCO-SPORTNCT04815447
Cardiopulmonary Fitness and Its Clinical Determinants of a Population of Childhood Cancer Survivor
An observational study of Childhood Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Childhood Cancer
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 20 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- childhood cancer survivors, VO2max, Ventilatory anaerobis threshold, Cardio-pulmonary exercise test, Hematopoietic stem cells transplantation, Radiotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Mar 2020
- Primary completion1 Feb 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Oncology Department, Montpellier University Hospital, France, Pediatric and Congenital Cardiology Department, Montpellier University Hospital, France
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, PhD, Study director, University Hospital, MontpellierArthur GAVOTTO, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815447
- Sponsor's protocol ID
- RECHMPL20_0089
- Acronym
- ONCO-SPORT
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
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.
PubMed 36709386
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Fitness and Its Clinical Determinants of a Population of Childhood Cancer Survivor: a Controlled Retrospective Study
- ClinicalTrials.gov ID
- NCT04815447
- Acronym / sponsor ID
- ONCO-SPORT / RECHMPL20_0089
- Conditions
- Childhood Cancer
- Keywords
- childhood cancer survivors, VO2max, Ventilatory anaerobis threshold, Cardio-pulmonary exercise test, Hematopoietic stem cells transplantation, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Pediatric Oncology Department, Montpellier University Hospital, France, Pediatric and Congenital Cardiology Department, Montpellier University Hospital, France
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison of VO2max for CCS patients compared to control children
Time frame: 1 day
comparison of the mean of VO2max value in ml/kg/min between CCS group and control group
2 secondary outcomes
comparison of ventilatory anaerobic threshold (VAT) for CCS patients compared to control children
Time frame: 1 day
correlation between clinical determinants and VO2max in the CCS group
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 36709386Gavotto 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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AMEDRO, MD, PhD study director
University Hospital, Montpellier
Arthur GAVOTTO principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of VO2max for CCS patients compared to control children (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.