Clinical trial NCT03885258: Melatonin Replacement Therapy in Pinealectomized Patients
Official title: Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pineal Tumor
Keywords: melatonin
pinealectomy
Cardiac Autonomic System
heart rate variability
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, single-arm, single-center, proof-of-concept study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: cardiac autonomic function - heart rate variability
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
state: Sao Paulo
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.