Oral Mucositis (Ulcerative) Due to RadiationPhase 2NCT03833570
Melatonin for Prevention of Radiation Induced Oral Mucositis
A Phase 2 study testing Rapid Release Capsules Melatonin, 10 mg, Miconaz oral gel and BBC oral spray in people with Oral Mucositis (Ulcerative) Due to Radiation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis (Ulcerative) Due to Radiation
- What is being tested?
- Rapid Release Capsules Melatonin, 10 mg, Miconaz oral gel and BBC oral spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2018to 1 Dec 2018
- Phase
- Phase 2
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
- Patients whose radiotherapy treatment planned dose is between 60-70 Gy.
- Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy.
Who cannot join
- Patients under Anticoagulants such as warfarin, heparin, or aspirin.
- Patients under Fluvoxamine (Luvox) and Nifedipine medications.
- Patients whose radiotherapy treatment planned dose is lower than 60 Gy.
- Pregnant and lactating women.
- Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
Alexandria
About this study
Official title: The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis
The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.
Read the detailed description
The study was designed as randomized, controlled, clinical trial. patients who were undergoing chemoradiation were divided into two groups: Group I: was given conventional treatment. Group II: was given melatonin therapy in combination with the conventional treatment.
All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity. in addition, the total antioxidant capacity of the melatonin was evaluated at the start of the radiotherapy and six weeks later.
- Being tested
- Rapid Release Capsules Melatonin, 10 mg, Miconaz oral gel, BBC oral spray, Oracure gel, Alkamisr sachets
- Keywords
- Melatonin
- Medical subject headings
- Stomatitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Release Capsules Melatonin, 10 mgDietary supplement
Melatonin is a dietary supplement which is naturally produced in the body and closely involved in the natural sleep cycle. recently topical and systemic melatonin supplements. have been proposed as a new therapeutic modality for oral mucositis due to its anti-cancer, anti-inflammatory, and anti-oxidant effects.
Miconaz oral gelDrug
Antifungal agent
BBC oral sprayDrug
Topical anesthetics and anti-inflammatory agent
Oracure gelDrug
Topical analgesic gel
Alkamisr sachetsOther
Sodium bicarbonate mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Melatonin therapy | Experimental | Rapid Release Capsules Melatonin, 10 mg in combination with the symptomatic treatment
Symptomatic treatment which included:
* Miconaz oral gel
* BBC oral spray
* Oracure gel
* Alkamisr sachets
Melatonin capsules dose: Two tablets,30 minutes before sleeping once daily for six weeks
Symptomatic treatment dose: Three times a day for six weeks Receives: Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg; Drug: Miconaz oral gel; Drug: BBC oral spray; Drug: Oracure gel; Other: Alkamisr sachets |
| Conventional therapy | Active comparator | Conventional therapy (symptomatic treatment) which included:
* Miconaz oral gel
* BBC oral spray
* Oracure gel
* Alkamisr sachets
Dose: Three times a day for six weeks Receives: Drug: Miconaz oral gel; Drug: BBC oral spray; Drug: Oracure gel; Other: Alkamisr sachets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in severity of oral mucositis at different time points along the study
Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session.
This scale combines both subjective and objective measures of oral mucositis.
World Health Organization (WHO) scale for oral mucositis:
- Grade 0 = No oral mucositis
- Grade 1 = Erythema and Soreness
- Grade 2 = Ulcers, able to eat solids
- Grade 3 = Ulcers, requires liquid diet (due to mucositis)
- Grade 4 = Ulcers, alimentation not possible (due to mucositis)
Measured: up to 3 and 6 weeks
Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study
TAC is an index that measures total capacity of antioxidants in biological fluids using Colorimetric Method. it can evaluate the antioxidant response against the free radicals produced by radiotherapy.
Normal reference values for TAC in saliva: 0.3-1 mM/L Higher values than normal range indicate higher level of TAC
Changes in the total antioxidant capacity were evaluated at the first day of radiotherapy session (baseline) and six weeks later
Measured: Baseline (day 0) and up to 6 weeks
Secondary outcomes (1)
Pain and discomfort severity at different time points along the study: Numeric Rating Scale
Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session.
The NRS was calibrated from 0 to 10 with ranges tagged as;
- No pain (NRS 0)
- Mild pain (NRS 1-3)
- Moderate pain (NRS 4-7)
- Unbearable pain (NRS 8-10)
Measured: up to 3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start12 Jan 2018
- Primary completion9 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Oral Mucositis (Ulcerative) Due to RadiationStudies 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Hossam H Abdelaziz Elsabbagh, BDS, Principal investigator, Alexandria UniversityEglal M Moussa, Phd, Study director, Alexandria UniversitySabah AH Mahmoud, Phd, Study director, University of AlexandriaRasha O Elsaka, Phd, Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833570
- Sponsor's protocol ID
- 0008839
- Status last verified
- Jun 2019
- First submitted
- 3 Feb 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.
PubMed 21133051Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
PubMed 15782422Campos MI, Campos CN, Aarestrup FM, Aarestrup BJ. Oral mucositis in cancer treatment: Natural history, prevention and treatment. Mol Clin Oncol. 2014 May;2(3):337-340. doi: 10.3892/mco.2014.253. Epub 2014 Feb 7.
PubMed 24772297Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.
PubMed 18360600Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.
PubMed 28589080Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8.
PubMed 15605918Lee CS, Ryan EJ, Doherty GA. Gastro-intestinal toxicity of chemotherapeutics in colorectal cancer: the role of inflammation. World J Gastroenterol. 2014 Apr 14;20(14):3751-61. doi: 10.3748/wjg.v20.i14.3751.
PubMed 24744571Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.
PubMed 25774860Volpato LE, Silva TC, Oliveira TM, Sakai VT, Machado MA. Radiation therapy and chemotherapy-induced oral mucositis. Braz J Otorhinolaryngol. 2007 Jul-Aug;73(4):562-8. doi: 10.1016/s1808-8694(15)30110-5.
PubMed 17923929Moslehi A, Taghizadeh-Ghehi M, Gholami K, Hadjibabaie M, Jahangard-Rafsanjani Z, Sarayani A, Javadi M, Esfandbod M, Ghavamzadeh A. N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: a double-blind, randomized, placebo-controlled trial. Bone Marrow Transplant. 2014 Jun;49(6):818-23. doi: 10.1038/bmt.2014.34. Epub 2014 Mar 10.
PubMed 24614837Hardeland R, Pandi-Perumal SR, Cardinali DP. Melatonin. Int J Biochem Cell Biol. 2006 Mar;38(3):313-6. doi: 10.1016/j.biocel.2005.08.020. Epub 2005 Sep 27.
PubMed 16219483Brasure M, MacDonald R, Fuchs E, Olson CM, Carlyle M, Diem S, Koffel E, Khawaja IS, Ouellette J, Butler M, Kane RL, Wilt TJ. Management of Insomnia Disorder [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Dec. Report No.: 15(16)-EHC027-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK343503/
PubMed 26844312Lyseng-Williamson KA. Melatonin prolonged release: in the treatment of insomnia in patients aged >/=55 years. Drugs Aging. 2012 Nov;29(11):911-23. doi: 10.1007/s40266-012-0018-z.
PubMed 23044640Lemoine P, Zisapel N. Prolonged-release formulation of melatonin (Circadin) for the treatment of insomnia. Expert Opin Pharmacother. 2012 Apr;13(6):895-905. doi: 10.1517/14656566.2012.667076. Epub 2012 Mar 19.
PubMed 22429105Zisapel N. [Controlled release melatonin (Circadin) in the treatment of insomnia in older patients: efficacy and safety in patients with history of use and non-use of hypnotic drugs]. Harefuah. 2009 May;148(5):337-41, 348. Hebrew.
PubMed 19630367
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT03833570
- Acronym / sponsor ID
- 0008839
- Keywords
- Melatonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 7 Feb 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.
The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.
Detailed description
The study was designed as randomized, controlled, clinical trial. patients who were undergoing chemoradiation were divided into two groups: Group I: was given conventional treatment. Group II: was given melatonin therapy in combination with the conventional treatment.
All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity. in addition, the total antioxidant capacity of the melatonin was evaluated at the start of the radiotherapy and six weeks later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin therapy | Experimental | Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg, Drug: Miconaz oral gel, Drug: BBC oral spray, Drug: Oracure gel, Other: Alkamisr sachetsRapid Release Capsules Melatonin, 10 mg in combination with the symptomatic treatment Symptomatic treatment which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Melatonin capsules dose: Two tablets,30 minutes before sleeping once daily for six weeks Symptomatic treatment dose: Three times a day for six weeks |
| Conventional therapy | Active comparator | Drug: Miconaz oral gel, Drug: BBC oral spray, Drug: Oracure gel, Other: Alkamisr sachetsConventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
- Patients whose radiotherapy treatment planned dose is between 60-70 Gy.
- Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy.
Key exclusion criteria (6 listed)
- Patients under Anticoagulants such as warfarin, heparin, or aspirin.
- Patients under Fluvoxamine (Luvox) and Nifedipine medications.
- Patients whose radiotherapy treatment planned dose is lower than 60 Gy.
- Pregnant and lactating women.
- Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
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 |
|---|---|---|
| Rapid Release Capsules Melatonin, 10 mgMelatonin is a dietary supplement which is naturally produced in the body and closely involved in the natural sleep cycle. recently topical and systemic melatonin supplements. have been proposed as a new therapeutic modality for oral mucositis due to its anti-cancer, anti-inflammatory, and anti-oxidant effects. | Dietary supplement | Melatonin therapy |
| Miconaz oral gelAntifungal agent | Drug | Conventional therapy, Melatonin therapy |
| BBC oral sprayTopical anesthetics and anti-inflammatory agent | Drug | Conventional therapy, Melatonin therapy |
| Oracure gelTopical analgesic gel | Drug | Conventional therapy, Melatonin therapy |
| Alkamisr sachetsSodium bicarbonate mouthwash | Other | Conventional therapy, Melatonin therapy |
Primary outcome
Changes in severity of oral mucositis at different time points along the study
Time frame: up to 3 and 6 weeks
Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session. This scale combines both subjective and objective measures of oral mucositis. World Health Organization (WHO) scale for oral mucositis: * Grade 0 = No oral mucositis * Grade 1 = Erythema and Soreness * Grade 2 = Ulcers, able to eat solids * Grade 3 = Ulcers, requires liquid diet (due to mucositis) * Grade 4 = Ulcers, alimentation not possible (due to mucositis)
Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study
Time frame: Baseline (day 0) and up to 6 weeks
TAC is an index that measures total capacity of antioxidants in biological fluids using Colorimetric Method. it can evaluate the antioxidant response against the free radicals produced by radiotherapy. Normal reference values for TAC in saliva: 0.3-1 mM/L Higher values than normal range indicate higher level of TAC Changes in the total antioxidant capacity were evaluated at the first day of radiotherapy session (baseline) and six weeks later
1 secondary outcome
Pain and discomfort severity at different time points along the study: Numeric Rating Scale
Time frame: up to 3 and 6 weeks
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 17 Jun 2019.
- Background: PubMed 21133051Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.
- Background: PubMed 15782422Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
- Background: PubMed 24772297Campos MI, Campos CN, Aarestrup FM, Aarestrup BJ. Oral mucositis in cancer treatment: Natural history, prevention and treatment. Mol Clin Oncol. 2014 May;2(3):337-340. doi: 10.3892/mco.2014.253. Epub 2014 Feb 7.
- Background: PubMed 18360600Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.
- Background: PubMed 28589080Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.
- Background: PubMed 15605918Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8.
- Background: PubMed 24744571Lee CS, Ryan EJ, Doherty GA. Gastro-intestinal toxicity of chemotherapeutics in colorectal cancer: the role of inflammation. World J Gastroenterol. 2014 Apr 14;20(14):3751-61. doi: 10.3748/wjg.v20.i14.3751.
- Background: PubMed 25774860Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.
- Background: PubMed 17923929Volpato LE, Silva TC, Oliveira TM, Sakai VT, Machado MA. Radiation therapy and chemotherapy-induced oral mucositis. Braz J Otorhinolaryngol. 2007 Jul-Aug;73(4):562-8. doi: 10.1016/s1808-8694(15)30110-5.
- Background: PubMed 24614837Moslehi A, Taghizadeh-Ghehi M, Gholami K, Hadjibabaie M, Jahangard-Rafsanjani Z, Sarayani A, Javadi M, Esfandbod M, Ghavamzadeh A. N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: a double-blind, randomized, placebo-controlled trial. Bone Marrow Transplant. 2014 Jun;49(6):818-23. doi: 10.1038/bmt.2014.34. Epub 2014 Mar 10.
- Background: PubMed 16219483Hardeland R, Pandi-Perumal SR, Cardinali DP. Melatonin. Int J Biochem Cell Biol. 2006 Mar;38(3):313-6. doi: 10.1016/j.biocel.2005.08.020. Epub 2005 Sep 27.
- Background: PubMed 26844312Brasure M, MacDonald R, Fuchs E, Olson CM, Carlyle M, Diem S, Koffel E, Khawaja IS, Ouellette J, Butler M, Kane RL, Wilt TJ. Management of Insomnia Disorder [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Dec. Report No.: 15(16)-EHC027-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK343503/
- WHO Handbook for Reporting Results of Cancer TreatmentLink provided by the sponsor.
- 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.
Hossam H Abdelaziz Elsabbagh, BDS principal investigator
Alexandria University
Eglal M Moussa, Phd study director
Alexandria University
Sabah AH Mahmoud, Phd study director
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rapid Release Capsules Melatonin, 10 mg, Miconaz oral gel and BBC oral spray in people with Oral Mucositis (Ulcerative) Due to Radiation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 3 inclusion and 6 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 17 Jun 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 Egypt. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in severity of oral mucositis at different time points along the study (time frame: up to 3 and 6 weeks). The study lists 2 primary outcomes in all. 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 NCT03833570, which also lists 23 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 17 Jun 2019; AzTrials last refreshed its copy on 26 Oct 2026.