Melatonin Replacement Therapy in Pinealectomized Patients

Early Phase 1CompletedNCT03885258

University of Sao Paulo5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pineal Tumor

Interventions

Melatonin Replacement TherapyDRUG

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.

Eligibility

Medical Language ↔ Plain English

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

Locations (1)

University of São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

cardiac autonomic function - heart rate variability

The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.

Time frame: 9 months

Data from ClinicalTrials.gov

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