This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients.

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients. The study consists of a screening period, followed by a 3-month melatonin treatment period, and a 6-month washout follow-up period. Adverse events were monitored with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.

Inclusion Criteria:

• patients with pinealectomy and all of the following criteria were considered for admission to the clinical trial:
• children, adolescents and young adults 0 months to 25 years of age;
• signed written informed consent (patient or his/her parents/legal guardian);
• willing and able to complete the clinical trial procedures, as described in the protocol
• no recurring tumor after pinealectomy and subsequent chemotherapy
• absence of circulating melatonin evaluated by salivary melatonin Elisa assay

Exclusion Criteria:

• patients with cardiac arrhythmias
• potentially non-compliant subjects judged by the investigator to be unsuitable for the study