SALTO-SNA: Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood
Study Details
Study Description
Brief Summary
The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en Oncologie des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne) coordinated by Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at re-examining, in their initial treatment center, all patients (a cohort of 495 patients alive in 2011), diagnosed between 1987 and 1992, and cured of childhood cancer (except leukemia) in the Rhône-Alpes and Auvergne regions.
The rationale for this study is based on the observation that although the survival rate of childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are high and greatly increase the risk of mortality in later years (estimated to be 14% in the literature).
The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor of cardiovascular morbidity to the individual.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
For this purpose, analysis of the cardiac RR variability is a reliable, non-invasive and reproducible system that could be used in this population as a tool for early detection of cardiovascular dysfunction.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Young adult survivors of childhood cancer Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France. |
Other: Autonomic nervous system activity records
The description of autonomic equilibrium is based on the use of non-invasive tools such as Holter-ECG monitor (24 hours) which is suitable for longitudinal follow up of cohorts of patients. This tool allows the analysis of instantaneous or delayed variability of the heart rate, in the Hertzian frequency domain after extraction and mathematical transformation of a temporal sequence of R-R spaces from the ECG signal.
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Outcome Measures
Primary Outcome Measures
- Autonomic nervous system activity [15 years after the end of the cancer treatment]
The autonomic status will be classified in sympatho-vagal equilibrium as "normal", "altered" or "severely abnormal" according to the values obtained for some temporal indices (SDNN, SDaNN, RMSSD etc. ..) and frequencies (Ptot, HF, LF , VLF, ratio LF / HF) compared to validated standards for the age (mean +/- standard deviation).
Secondary Outcome Measures
- Doses of radiotherapy [15 years after the end of the cancer treatment]
Regarding radiotherapy, the doses of different vital organs of the body (151 anatomic sites) will be estimated from the radiotherapy technical records with the help of the Dos-EG software proposed by the INSERM team of F De Vathaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Included in the SALTO study
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Having signed the informed consent form
Exclusion Criteria:
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General anesthesia in the two weeks prior to recording
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Known allergy to electrodes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Clermont-Ferrand | Clermont-ferrand | France | 63000 | |
| 2 | CHU de Grenoble | Grenoble | France | 38000 | |
| 3 | IHOP | Lyon | France | 69000 | |
| 4 | CHU de Saint-Etienne | Saint-etienne | France | 42000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
Investigators
- Principal Investigator: Claire BERGER, MD, CHU de Saint-Etienne
- Study Director: Hugues PATURAL, MD PhD, CHU de Saint-Etienne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1108162
- 2011-A01357-34