Clinical trial · Interventional
Melatonin Replacement Therapy in Pinealectomized Patients
Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients
NCT03885258CI-TRIAL-00037741completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pineal Tumor | Pineal Region Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin Replacement Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Melatonin Replacement Therapy
- 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.
- interventionNames
- Drug: Melatonin Replacement Therapy
Primary outcomes (1)
- measure
- cardiac autonomic function - heart rate variability
- timeFrame
- 9 months
- description
- The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.
Eligibility
Eligibility (as posted)
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDCipolla-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
- BACKGROUNDBaltatu 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
- BACKGROUNDCampos 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
- BACKGROUNDPereira 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
- BACKGROUNDCampos 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
- BACKGROUNDShaffer 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
- DERIVEDCampos 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