Pineal TumorEarly Phase 1NCT03885258
Melatonin Replacement Therapy in Pinealectomized Patients
A Early Phase 1 study testing Melatonin Replacement Therapy in people with Pineal Tumor, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pineal Tumor
- What is being tested?
- Melatonin Replacement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2017to 28 Feb 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with cardiac arrhythmias
- potentially non-compliant subjects judged by the investigator to be unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients
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.
Read the 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.
- Conditions
- Pineal Tumor
- Being tested
- Melatonin Replacement Therapy
- Keywords
- melatonin, pinealectomy, Cardiac Autonomic System, heart rate variability
- Medical subject headings
- Pinealoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin Replacement TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Melatonin Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac autonomic function - heart rate variability
The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start2 May 2017
- Primary completion30 Nov 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pineal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single-arm, single-center, proof-of-concept study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ovidiu Constantin Baltatu, Anhembi Morumbi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885258
- Sponsor's protocol ID
- 30460114.5.0000.0068
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30215696Baltatu 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.
PubMed 28791422Campos 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.
PubMed 23531786Pereira 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.
PubMed 28491040Campos 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.
PubMed 24109456Shaffer 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.
PubMed 29034226Campos 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.
PubMed 32431667
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients
- ClinicalTrials.gov ID
- NCT03885258
- Acronym / sponsor ID
- 30460114.5.0000.0068
- Conditions
- Pineal Tumor
- Keywords
- melatonin, pinealectomy, Cardiac Autonomic System, heart rate variability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-arm, single-center, proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| Melatonin Replacement Therapy | Experimental | Drug: Melatonin Replacement TherapyMelatonin (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. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- patients with cardiac arrhythmias
- potentially non-compliant subjects judged by the investigator to be unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin Replacement TherapyMelatonin (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 |
Primary outcome
cardiac autonomic function - heart rate variability
Time frame: 9 months
The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 30215696Cipolla-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.
- Background: PubMed 28791422Baltatu 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.
- Background: PubMed 23531786Campos 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.
- Background: PubMed 28491040Pereira 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.
- Background: PubMed 24109456Campos 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.
- Background: PubMed 29034226Shaffer 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.
- Derived from this study: PubMed 32431667Campos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin Replacement Therapy in people with Pineal Tumor, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac autonomic function - heart rate variability (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885258, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.