Metastatic Malignant Neoplasm to BrainPhase 2NCT04801342
Neurocognitive Outcome of Bilateral or Unilateral Hippocampal Avoidance WBRT With Memantine for Brain Metastases
A Phase 2 study testing Conformal Whole Brain Radiotherapy with Unilateral Hippocampal Avoidance, Conformal Whole Brain Radiotherapy with Bilateral Hippocampal Avoidance and Memantine Hydrochloride in people with Metastatic Malignant Neoplasm to Brain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness. Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm to Brain
- What is being tested?
- Conformal Whole Brain Radiotherapy with Unilateral Hippocampal Avoidance, Conformal Whole Brain Radiotherapy with Bilateral Hippocampal Avoidance and Memantine Hydrochloride
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2021to 28 Feb 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic evidence of brain metastases
- Patients with brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI obtained within 30 days prior to registration
- Patients with brain metastasis who have not been or will not be treated with SRS, or have received SRS for ≤ 5 intracranial metastatic lesion(s)
- No evidence of diffuse leptomeningeal metastasis on gadolinium- enhanced MRI within 30 days prior registration
- Age ≥ 20 years
- Karnofsky Performance Status ≥ 60%
Show all 9Show fewer
- Life expectancy of ≥ 6 months.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
Who cannot join
- Prior radiotherapy to brain or radiosurgery to > 5 intracranial metastatic lesion(s) or the biological equivalent dose in 2-Gy fractions was greater than 7.3Gy to 40% of the volume of bilateral hippocampus from prior radiosurgery
- Serum creatinine > 2.0 mg/dL within 30 days prior registration
- Serum urea nitrogen > 20 mg/dL within 30 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
Show all 16Show fewer
- Transmural myocardial infarction ≤ 6 months prior to registration
- Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
- Life-threatening uncontrolled clinically significant cardiac arrhythmias
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Uncontrolled psychiatric disorder
- Will receive any other investigational agent or chemotherapy during WBRT
- Current use of Memantine HCL or Allergy to Memantine HCL
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Feng-Ming Hsu, MD, +886-2-23123456 ext. 67061, hsufengming@ntuh.gov.tw
About this study
Official title: Neurocognitive Outcome of Conformal Whole Brain Radiotherapy With Bilateral or Unilateral Hippocampal Avoidance Plus Memantine for Brain Metastases: A Phase II Single Blind Randomized Trial
Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness.
Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function decline caused by intracranial lesions. By using conventional fractionation, more than one- third of patients developed late neurocognitive toxicity while memory impairment was the most common symptom. The incidence is even higher when a formal and sensitive neurocognitive assessment was prospectively evaluated. With more long-term survivors nowadays, it has become increasingly important to minimize neurocognitive function decline and maintain quality of life in patients with brain metastasis.
Read more
The function of hippocampus is cooperation in learning, consolidation and retrieval of information and essential for formation of new memories. Bilateral and unilateral radiation injury of the hippocampus is known to alter learning and memory formation. Several preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is associated with subsequent neurocognitive function impairment in adult and pediatric patients. Furthermore, the result of phase III randomized trials suggested hippocampal avoidance plus Memantine significantly reduce the risk of neurocognitive impairment at 6 months from 68.2% in control arm with standard WBRT to 59.5% in experimental arm. In the investigator's prior investigation, patients received conformal WBRT with bilateral hippocampal avoidance also had significant less declines in verbal memory at 6 months.
Previous studies showed the right and left hippocampus exert different neurocognitive functions. Several retrospective studies also demonstrated that the radiation dose to the left hippocampus is more related to neurocognitive impairment. Planning study and investigation showed that by avoiding the left hippocampus alone, the radiation dose to the spared unilateral hippocampus is further decreased. In present study, a single blind randomized phase II trial is designed to investigate the effectiveness of neurocognitive function preservation using conformal WBRT with bilateral or unilateral hippocampal avoidance and memantine.
- Conditions
- Metastatic Malignant Neoplasm to Brain
- Being tested
- Conformal Whole Brain Radiotherapy with Unilateral Hippocampal Avoidance, Conformal Whole Brain Radiotherapy with Bilateral Hippocampal Avoidance, Memantine Hydrochloride
- Keywords
- Brain Metastases, Hippocampal Avoidance Whole Brain Radiotherapy, Neurocognitive function
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conformal Whole Brain Radiotherapy with Unilateral Hippocampal AvoidanceRadiation
Also called Unilateral HA-WBRT
Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Unilateral Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
Conformal Whole Brain Radiotherapy with Bilateral Hippocampal AvoidanceRadiation
Also called Bilateral HA-WBRT
Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Bilateral Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
Memantine HydrochlorideDrug
Also called Memantine
Start from day 1 of WBRT orally for 24 weeks and escalating doses over the first 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Hippocampal Avoidance WBRT with Memantine | Experimental | Conformal whole brain radiotherapy with unilateral hippocampal avoidance and Concurrent use of Memantine HCL Receives: Radiation: Conformal Whole Brain Radiotherapy with Unilateral Hippocampal Avoidance; Drug: Memantine Hydrochloride |
| Bilateral Hippocampal Avoidance WBRT with Memantine | Active comparator | Conformal whole brain radiotherapy with bilateral hippocampal avoidance and Concurrent use of Memantine HCL Receives: Radiation: Conformal Whole Brain Radiotherapy with Bilateral Hippocampal Avoidance; Drug: Memantine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Verbal Learning Test-Revised (HVLT-R) memory score
Decline in Hopkins Verbal Learning Test-Revised (HVLT-R) memory score (sum of total recall and recognition index) from baseline to 6 months after the start of conformal whole brain radiotherapy (WBRT) with bilateral or unilateral hippocampal avoidance for multiple brain metastases. HVLT-R Total recall raw scores ranged from 0 to 36, recognition index ranged from 0 to 12. The higher the score indicated better short term memory preservation
Measured: At 6 months after WBRT
Secondary outcomes (9)
Neurocognitive function by a standardized neurocognitive battery Hopkins Verbal Learning Test-Revised (HVLT-R)
Evaluate neurocognitive function by a standardized neurocognitive battery Hopkins Verbal Learning Test-Revised (HVLT-R) with Total recall score (range from 0 to 36), delayed recall score (range from 0 to 12) and recognition index (range from 0 to 12). The higher the score indicated better short term memory preservation.
Measured: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Neurocognitive function by a standardized neurocognitive battery Trail Making Test Part A & B
Evaluate neurocognitive function by a standardized neurocognitive battery Trail Making Test Part A \& B. TMT-A and B tested the executive function documented with time needed for complete test with no upper limit of range. The longer the time needed, the worse executive function patients preserved.
Measured: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Neurocognitive function by a standardized neurocognitive battery Controlled Oral Word Association Test
Evaluate neurocognitive function by a standardized neurocognitive battery Controlled Oral Word Association Test. Patients are given one phoneme at a time and instructed to say aloud as many words beginning with that phoneme as they could within 1 minute, for a total of three phonemes in 3 minutes. The more the words patients able to say in limit time, the better outcome presented.
Measured: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Patient reported outcome (Quality of Life questionnaire)
EORTC Quality of Life-Core 30 questionnaire module (at question 1 to 27, range from 1 to 4; at question 29 and 30, range from 1 to 7) Quality of Life questionnaire-Brain.
Measured: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Patient reported outcome (Cognitive Functioning questionnaire)
Function Assessment Cancer Therapy for patients with Cognitive function issue
Measured: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Common Toxicity Criteria for Adverse Events version 4
Measured: From date of WBRT until 90 days after radiotherapy starts
Late toxicity (Common Toxicity Criteria for Adverse Events version 4)
Common Toxicity Criteria for Adverse Events version 4
Measured: From 90 days after WBRT starts until the date of death from any cause, up to 60 months
Intracranial progression (Number of participant with intracranial progression on MRI of brain)
Number of participant with intracranial progression on MRI of brain
Measured: From date of enrolment until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Number of patients died
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm to BrainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Ming Hsu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801342
- Sponsor's protocol ID
- 201901084MINA
- Status last verified
- Jan 2021
- First submitted
- 28 Apr 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Outcome of Conformal Whole Brain Radiotherapy With Bilateral or Unilateral Hippocampal Avoidance Plus Memantine for Brain Metastases: A Phase II Single Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT04801342
- Acronym / sponsor ID
- 201901084MINA
- Conditions
- Metastatic Malignant Neoplasm to Brain
- Keywords
- Brain Metastases, Hippocampal Avoidance Whole Brain Radiotherapy, Neurocognitive function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 17 Mar 2021 (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.
Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness.
Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function decline caused by intracranial lesions. By using conventional fractionation, more than one- third of patients developed late neurocognitive toxicity while memory impairment was the most common symptom. The incidence is even higher when a formal and sensitive neurocognitive assessment was prospectively evaluated. With more long-term survivors nowadays, it has become increasingly important to minimize neurocognitive function decline and maintain quality of life in patients with brain metastasis.
The function of hippocampus is cooperation in learning, consolidation and retrieval of information and essential for formation of new memories. Bilateral and unilateral radiation injury of the hippocampus is known to alter learning and memory formation. Several preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is associated with subsequent neurocognitive function impairment in adult and pediatric patients. Furthermore, the result of phase III randomized trials suggested hippocampal avoidance plus Memantine significantly reduce the risk of neurocognitive impairment at 6 months from 68.2% in control arm with standard WBRT to 59.5% in experimental arm. In the investigator's prior investigation, patients received conformal WBRT with bilateral hippocampal avoidance also had significant less declines in verbal memory at 6 months.
Previous studies showed the right and left hippocampus exert different neurocognitive functions. Several retrospective studies also demonstrated that the radiation dose to the left hippocampus is more related to neurocognitive impairment. Planning study and investigation showed that by avoiding the left hippocampus alone, the radiation dose to the spared unilateral hippocampus is further decreased. In present study, a single blind randomized phase II trial is designed to investigate the effectiveness of neurocognitive function preservation using conformal WBRT with bilateral or unilateral hippocampal avoidance and memantine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral Hippocampal Avoidance WBRT with Memantine | Experimental | Radiation: Conformal Whole Brain Radiotherapy with Unilateral Hippocampal Avoidance, Drug: Memantine HydrochlorideConformal whole brain radiotherapy with unilateral hippocampal avoidance and Concurrent use of Memantine HCL |
| Bilateral Hippocampal Avoidance WBRT with Memantine | Active comparator | Radiation: Conformal Whole Brain Radiotherapy with Bilateral Hippocampal Avoidance, Drug: Memantine HydrochlorideConformal whole brain radiotherapy with bilateral hippocampal avoidance and Concurrent use of Memantine HCL |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic evidence of brain metastases
- Patients with brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI obtained within 30 days prior to registration
- Patients with brain metastasis who have not been or will not be treated with SRS, or have received SRS for ≤ 5 intracranial metastatic lesion(s)
- No evidence of diffuse leptomeningeal metastasis on gadolinium- enhanced MRI within 30 days prior registration
- Age ≥ 20 years
Key exclusion criteria (16 listed)
- Prior radiotherapy to brain or radiosurgery to > 5 intracranial metastatic lesion(s) or the biological equivalent dose in 2-Gy fractions was greater than 7.3Gy to 40% of the volume of bilateral hippocampus from prior radiosurgery
- Serum creatinine > 2.0 mg/dL within 30 days prior registration
- Serum urea nitrogen > 20 mg/dL within 30 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
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 |
|---|---|---|
| Conformal Whole Brain Radiotherapy with Unilateral Hippocampal AvoidanceAlso: Unilateral HA-WBRTConformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Unilateral Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy | Radiation | Unilateral Hippocampal Avoidance WBRT with Memantine |
| Conformal Whole Brain Radiotherapy with Bilateral Hippocampal AvoidanceAlso: Bilateral HA-WBRTConformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Bilateral Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy | Radiation | Bilateral Hippocampal Avoidance WBRT with Memantine |
| Memantine HydrochlorideAlso: MemantineStart from day 1 of WBRT orally for 24 weeks and escalating doses over the first 4 weeks | Drug | Bilateral Hippocampal Avoidance WBRT with Memantine, Unilateral Hippocampal Avoidance WBRT with Memantine |
Primary outcome
Hopkins Verbal Learning Test-Revised (HVLT-R) memory score
Time frame: At 6 months after WBRT
Decline in Hopkins Verbal Learning Test-Revised (HVLT-R) memory score (sum of total recall and recognition index) from baseline to 6 months after the start of conformal whole brain radiotherapy (WBRT) with bilateral or unilateral hippocampal avoidance for multiple brain metastases. HVLT-R Total recall raw scores ranged from 0 to 36, recognition index ranged from 0 to 12. The higher the score indicated better short term memory preservation
9 secondary outcomes
Neurocognitive function by a standardized neurocognitive battery Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Neurocognitive function by a standardized neurocognitive battery Trail Making Test Part A & B
Time frame: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Neurocognitive function by a standardized neurocognitive battery Controlled Oral Word Association Test
Time frame: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Patient reported outcome (Quality of Life questionnaire)
Time frame: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Patient reported outcome (Cognitive Functioning questionnaire)
Time frame: at 1, 2, 4, 6, 9, 12 months after WBRT, and then every 3 months until date of death from any cause, assessed up to 24 months
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Time frame: From date of WBRT until 90 days after radiotherapy starts
Late toxicity (Common Toxicity Criteria for Adverse Events version 4)
Time frame: From 90 days after WBRT starts until the date of death from any cause, up to 60 months
Intracranial progression (Number of participant with intracranial progression on MRI of brain)
Time frame: From date of enrolment until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- 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.
Feng-Ming Hsu, MD, PhD principal investigator
National Taiwan University Hospital
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 Conformal Whole Brain Radiotherapy with Unilateral Hippocampal Avoidance, Conformal Whole Brain Radiotherapy with Bilateral Hippocampal Avoidance and Memantine Hydrochloride in people with Metastatic Malignant Neoplasm to Brain, run by National Taiwan University Hospital at 1 site in Taiwan.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 17 Mar 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng-Ming Hsu, MD, PhD (+886-2-23123456 ext. 67061, hsufengming@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Verbal Learning Test-Revised (HVLT-R) memory score (time frame: At 6 months after WBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2021.