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

Cancer Clinical Trial

— SALTO-SNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574196
• Other study ID #: 1108162
• Secondary ID: 2011-A01357-34
• Status: Completed
• Phase: N/A
• First received: April 6, 2012
• Last updated: March 30, 2015
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Nervous System
• Cancer
• Complications
• Sequels

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-ferrand
France	CHU de Grenoble	Grenoble
France	IHOP	Lyon
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic nervous system activity	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).	15 years after the end of the cancer treatment	No
Secondary	Doses of radiotherapy	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.	15 years after the end of the cancer treatment	No