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Melatonin Replacement Therapy in Pinealectomized Patients

Primary Purpose

Pineal Tumor

Status
Completed
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Melatonin Replacement Therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pineal Tumor focused on measuring melatonin, pinealectomy, Cardiac Autonomic System, heart rate variability

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept 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

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melatonin Replacement Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
March 20, 2019
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03885258
Brief Title
Melatonin Replacement Therapy in Pinealectomized Patients
Official Title
Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pineal Tumor
Keywords
melatonin, pinealectomy, Cardiac Autonomic System, heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label, single-arm, single-center, proof-of-concept study
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin Replacement Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Melatonin Replacement Therapy
Intervention Description
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 Outcome Measure Information:
Title
cardiac autonomic function - heart rate variability
Description
The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.
Time Frame
9 months

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30215696
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.
Results Reference
background
PubMed Identifier
28791422
Citation
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.
Results Reference
background
PubMed Identifier
23531786
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.
Results Reference
background
PubMed Identifier
28491040
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.
Results Reference
background
PubMed Identifier
24109456
Citation
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.
Results Reference
background
PubMed Identifier
29034226
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.
Results Reference
background
PubMed Identifier
32431667
Citation
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.
Results Reference
derived

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Melatonin Replacement Therapy in Pinealectomized Patients

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