NCT01574196

Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood

Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood. Ancillary Study of the "Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France" Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cancer
• Sequels
• Complications
• Autonomic Nervous System

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-04-10
• Last updated: 2015-03-31

Locations

4 sites across 1 country: France