Melatonin Replacement Therapy in Pinealectomized Patients

Pineal Tumor Clinical Trial

Official title:

Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885258
• Other study ID #: 30460114.5.0000.0068
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 28, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pineal Tumor
• Pinealoma

Intervention

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.

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

Campos LA, Pereira VL Jr, Muralikrishna A, Albarwani S, Brás 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac autonomic function - heart rate variability	The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.	9 months