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

Completed

• Conditions: Autonomic Nervous System; Cancer; Sequels; Complications
• Interventions: Other: Autonomic nervous system activity records

• Registration Number: NCT01574196
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

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 Timeline

• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Study Start: 2012-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Included in the SALTO study
• Having signed the informed consent form

Exclusion Criteria

• General anesthesia in the two weeks prior to recording
• Known allergy to electrodes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young adult survivors of childhood cancer	Autonomic nervous system activity records	Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (4)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

IHOP; 🇫🇷 Lyon, France