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Completed

NCT Number: NCT03885258

Melatonin Replacement Therapy in 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.

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Key information

Conditions

Pineal Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Pinealoma

Study type

Interventional

Phase

Early Phase 1

Primary location

University of São Paulo

São Paulo, 05508-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin Replacement Therapy

Drug

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.

Primary outcomes

  1. cardiac autonomic function - heart rate variability

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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