Melatonin Replacement Therapy in Pinealectomized Patients

NCT03885258 | Completed Early Phase 1

• 1 other identifier: 30460114.5.0000.0068
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pineal Tumor

Keywords

melatonin; pinealectomy; Cardiac Autonomic System; heart rate variability

Outcome Measures

Primary Outcomes (1)

• cardiac autonomic function - heart rate variability

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

  9 months

Study Arms (1)

Melatonin Replacement Therapy

EXPERIMENTAL

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

Interventions

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.

Melatonin Replacement Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (7)

• Cipolla-Neto J, Amaral FGD. Melatonin as a Hormone: New Physiological and Clinical Insights. Endocr Rev. 2018 Dec 1;39(6):990-1028. doi: 10.1210/er.2018-00084.

  PMID: 30215696 BACKGROUND

• Baltatu OC, Amaral FG, Campos LA, Cipolla-Neto J. Melatonin, mitochondria and hypertension. Cell Mol Life Sci. 2017 Nov;74(21):3955-3964. doi: 10.1007/s00018-017-2613-y. Epub 2017 Aug 8.

  PMID: 28791422 BACKGROUND

• Campos LA, Cipolla-Neto J, Michelini LC. Melatonin modulates baroreflex control via area postrema. Brain Behav. 2013 Mar;3(2):171-7. doi: 10.1002/brb3.123. Epub 2013 Feb 17.

  PMID: 23531786 BACKGROUND

• Pereira VL Jr, Dobre M, Dos Santos SG, Fuzatti JS, Oliveira CR, Campos LA, Brateanu A, Baltatu OC. Association between Carotid Intima Media Thickness and Heart Rate Variability in Adults at Increased Cardiovascular Risk. Front Physiol. 2017 Apr 26;8:248. doi: 10.3389/fphys.2017.00248. eCollection 2017.

  PMID: 28491040 BACKGROUND

• Campos LA, Pereira VL Jr, Muralikrishna A, Albarwani S, Bras S, Gouveia S. Mathematical biomarkers for the autonomic regulation of cardiovascular system. Front Physiol. 2013 Oct 7;4:279. doi: 10.3389/fphys.2013.00279.

  PMID: 24109456 BACKGROUND

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 BACKGROUND

• Campos LA, Bueno C, Barcelos IP, Halpern B, Brito LC, Amaral FG, Baltatu OC, Cipolla-Neto J. Melatonin Therapy Improves Cardiac Autonomic Modulation in Pinealectomized Patients. Front Endocrinol (Lausanne). 2020 Apr 30;11:239. doi: 10.3389/fendo.2020.00239. eCollection 2020.

  PMID: 32431667 DERIVED

MeSH Terms

Conditions

Pinealoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-PI to PI - José Cipolla-Neto

Model Details: This is an open-label, single-arm, single-center, proof-of-concept study

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 21, 2019
• Study Start: May 2, 2017
• Primary Completion: November 30, 2018
• Study Completion: February 28, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)