Melatonin Replacement Therapy in Pinealectomized Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients

Conditions
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Pineal Tumor

Intervention / Treatment
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* Drug: Melatonin Replacement Therapy


Participation Criteria
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Eligibility Criteria
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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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open-label, single-arm, single-center, proof-of-concept study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin Replacement Therapy<br>Melatonin (Aché Pharmaceutics, Brazil) 3 mg, administered in the evening, 30 minutes before the usual bedtime, every day for 3 months. After discontinuation of melatonin therapy, patients are followed up for 6 months to assess safety parameters and cardiac autonomic activity. | Drug: Melatonin Replacement Therapy<br>* Melatonin (Aché Pharmaceutics, Brazil), 3 mg, administered in the evening, 30 minutes before the usual bedtime, every day for 3 months. After discontinuation of melatonin therapy, patients are followed up for 6 months to assess safety parameters and cardiac autonomic activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac autonomic function - heart rate variability | The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, pinealectomy, Cardiac Autonomic System, heart rate variability