Melatonin Replacement Therapy in Pinealectomized Patients

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03885258

Collaborator

(none)

Enrollment

Location

Arm

21.9

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pineal Tumor	Drug: Melatonin Replacement Therapy	Early Phase 1

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is an open-label, single-arm, single-center, proof-of-concept studyThis is an open-label, single-arm, single-center, proof-of-concept study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients

Actual Study Start Date :

May 2, 2017

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Feb 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin Replacement Therapy 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 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.

Arm

Intervention/Treatment

Experimental: Melatonin Replacement Therapy

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

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.

Outcome Measures

Primary Outcome Measures

cardiac autonomic function - heart rate variability [9 months]
The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of São Paulo	São Paulo	Sao Paulo	Brazil	05508-000

Sponsors and Collaborators

University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ovidiu Constantin Baltatu, Co-PI to PI - José Cipolla-Neto, Anhembi Morumbi University

ClinicalTrials.gov Identifier:

NCT03885258

Other Study ID Numbers:

30460114.5.0000.0068

First Posted:

Mar 21, 2019

Last Update Posted:

Mar 21, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ovidiu Constantin Baltatu, Co-PI to PI - José Cipolla-Neto, Anhembi Morumbi University

melatonin

pinealectomy

Cardiac Autonomic System

heart rate variability

Additional relevant MeSH terms:

Pinealoma

Melatonin

Study Results

No Results Posted as of Mar 21, 2019