Breast CancerNCT07693374
Chinese Medicinal Component Relieves CIPN and Mitochondria Function
A study testing Moutan cortex in people with Breast Cancer and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Taiwan Municipal An-Nan Hospital-China Medical University at 1 site in Taiwan.
Trial summary
A randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Moutan cortex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 30 Aug 2025
- Phase
- Interventional
- 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
- adult women above 20 years, diagnosed with stage I-III breast cancer by a histological analysis, and who had completed adjuvant or neoadjuvant neurotoxic chemotherapy (including taxane-based or platinum-based), with the severity of CIPN matching the definition of the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 version more than grade 1. In addition, the patients' daily physical status will match the definition of the Eastern Cooperative Oncology Group (ECOG) performance status less than grade 3
Who cannot join
- metastatic breast cancer, a history of diabetic neurological disease before chemotherapy, other pre-existing peripheral neurological disorders, a history of inflammatory or metabolic arthritis, severe coagulopathy or potential bleeding tendency, dermatological disease within acupuncture needling area. Concomitant use of selected analgesics was allowed23 (e.g.,opioids, acetaminophen, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs]), but only patients receiving stable doses in the two weeks prior to randomization could participate: 1) no new analgesics were added; 2) no analgesics were discontinued; and 3) the weekly 24-hour total analgesic dose did not fluctuate up or down by > 10% in the two weeks prior to study registration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Chinese Medicinal Component Relieves the Chemotherapy-induced Peripheral Neuropathy and the Relating Changes of Mitochondria Function in Dorsal Root Ganglion: Basic and Clinical Research
A randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. This research project will validate our new preliminary findings demonstrating the neuroprotective effects after paclitaxel treatment. Importantly, our data are expected to elucidate the way Moutan Cortex induces neuroprotection in the clinical setting and provide a scientific basis for the development of new approaches to treat CIPN.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling pain condition that involves structural and functional impairment of peripheral motor, sensory, and autonomic neurons. CIPN symptoms may involve a combination of motor, sensory, and autonomic deficits. Sensory symptoms are the most common and are usually the first to appear, affecting the hands and feet the most. Sensory symptoms usually manifest as spontaneous or induced abnormal sensations, such as abnormal sensation, sensory dullness, numbness, burning, shooting or electric shock sensations, and unusual pain or pain hypersensitivity induced by mechanical or thermal stimuli. Paclitaxel drugs are among the most commonly used neurotoxic chemotherapeutic agents. In the absence of effective conventional treatments, there are limited effective ways to prevent or treat CIPN. The traditional Chinese medicine, Moutan Cortex, has long been used for its anticoagulant, anti-inflammatory, analgesic, and sedative activities, as well as for the treatment of cardiovascular, hemorrhagic, stagnated blood, and female genital disorders. Studies have shown that paeonol, a major component of Moutan Cortex, has analgesic, antipyretic and antibacterial properties, as well as anti-inflammatory, antioxidant and anti-platelet aggregation effects. It has a wide range of properties, such as inhibiting collagen-induced platelet aggregation and attenuating inflammatory responses in airways, coronary arteries, macrophages and microglia. Preliminary results in a baseline study showed that intraperitoneal administration of paclitaxel reduced the mechanical nociceptive threshold in the hind palm, indicating increased sensitivity to painful stimuli (mechanical allodynia pain). In contrast, the reduction in mechanical nociceptive threshold in the hind palm induced by paclitaxel was significantly reversed after oral administration of different doses of dandruff and approached that of the control group without paclitaxel, showing a significant improvement in mechanical anomalous pain. Therefore, a randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. This research project will validate our new preliminary findings demonstrating the neuroprotective effects after paclitaxel treatment. Importantly, our data are expected to elucidate the way Moutan Cortex induces neuroprotection in the clinical setting and provide a scientific basis for the development of new approaches to treat CIPN.
- Being tested
- Moutan cortex, sham moutan cortex
- Keywords
- chemotherapy-induced peripheral neuropathy, paclitaxel, Moutan Cortex, neuropathic pain
- Medical subject headings
- Breast Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moutan cortexDrug
Moutan Cortex, the certified pharmaceutical name is "Moutan radices extract power". The purchased powder is manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan (No. 0714A) and standardized with a standard product of Moutan Cortex certified by Taiwan Food and Drug Administration (certified no. 003053).
sham moutan cortexDrug
The sham Moutan cortex powder will also be manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan. Each participant will intake sham moutan cortex 2g/day daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Moutan cortex group | Experimental | Moutan Cortex, the certified pharmaceutical name is "Moutan radices extract power". The purchased powder is manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan (No. 0714A) and standardized with a standard product of Moutan Cortex certified by Taiwan Food and Drug Administration (certified no. 003053). Each participant will intake moutan cortex 2g/day daily for 4 weeks. Receives: Drug: Moutan cortex |
| Sham Moutan cortex group | Sham comparator | The sham Moutan cortex powder will also be manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan. Each participant will intake sham moutan cortex 2g/day daily for 4 weeks. Receives: Drug: sham moutan cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPI-SF;the Brief Pain Inventory-Short Form
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form24 (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.
Measured: BPI-SF will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)
Secondary outcomes (2)
SWM
von Frey monofilaments (Semmes-Weinstein von Frey Aesthesiometer, Stoelting Co., Wood Dale, IL, USA):a set of 20 von Frey monofilaments with evaluator size/target forces ranging from 1.65/0.008 g to 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Measurement sites included the sole, tip of the big toe, palm, and tip of the middle finger. All tests were performed by an independent assessor who was blinded to the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer.
Measured: SWM will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)
The 13-item FACT/GOG-Ntx subscale
The 13-item FACT/GOG-Ntx subscale26 measures the severity and impact of neurotoxicity symptoms over the past seven days. The instrument assesses sensory symptoms, such as numbness, tingling, and discomfort in hands and feet, motor symptoms such as trouble walking, buttoning buttons, and ototoxicity, such as ringing or buzzing in the ear. Items are rated on a five-point scale, scored from 0 to 4 (0 = not at all; 4 = very much) and summed (total score range = 0-52). Higher scores on the neurotoxicity scale indicate improvements in neurotoxic symptoms.
Measured: FACT/GOG-Ntx subscale will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2022
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Why it stopped: Initial prep showed that formulation, QC, and cost for high-dose paeonol/Cortex Moutan exceeded the budget. Also, recruiting patients with chemotherapy-induced peripheral neuropathy was limited. To ensure safety, enrollment did not officially launch.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Municipal An-Nan Hospital-China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, Taiwan
- Responsible party
- Principal investigator, Chien-Chen Huang, Taiwan Municipal An-Nan Hospital-China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693374
- Sponsor's protocol ID
- TMANH111-REC005(TR)
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hirai A, Terano T, Hamazaki T, Sajiki J, Saito H, Tahara K, Tamura Y, Kumagai A. Studies on the mechanism of antiaggregatory effect of Moutan Cortex. Thromb Res. 1983 Jul 1;31(1):29-40. doi: 10.1016/0049-3848(83)90005-1.
PubMed 6412397Hu LY, Mi WL, Wu GC, Wang YQ, Mao-Ying QL. Prevention and Treatment for Chemotherapy-Induced Peripheral Neuropathy: Therapies Based on CIPN Mechanisms. Curr Neuropharmacol. 2019;17(2):184-196. doi: 10.2174/1570159X15666170915143217.
PubMed 28925884Wang Z, He C, Peng Y, Chen F, Xiao P. Origins, Phytochemistry, Pharmacology, Analytical Methods and Safety of Cortex Moutan (Paeonia suffruticosa Andrew): A Systematic Review. Molecules. 2017 Jun 7;22(6):946. doi: 10.3390/molecules22060946.
PubMed 28590441
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chinese Medicinal Component Relieves the Chemotherapy-induced Peripheral Neuropathy and the Relating Changes of Mitochondria Function in Dorsal Root Ganglion: Basic and Clinical Research
- ClinicalTrials.gov ID
- NCT07693374
- Acronym / sponsor ID
- TMANH111-REC005(TR)
- Keywords
- chemotherapy-induced peripheral neuropathy, paclitaxel, Moutan Cortex, neuropathic pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Initial prep showed that formulation, QC, and cost for high-dose paeonol/Cortex Moutan exceeded the budget. Also, recruiting patients with chemotherapy-induced peripheral neuropathy was limited. To ensure safety, enrollment did not officially launch.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taiwan Municipal An-Nan Hospital-China Medical UniversityUniversity, hospital or other
- Collaborators
- China Medical University, Taiwan
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 9 Jul 2026 (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.
A randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. This research project will validate our new preliminary findings demonstrating the neuroprotective effects after paclitaxel treatment. Importantly, our data are expected to elucidate the way Moutan Cortex induces neuroprotection in the clinical setting and provide a scientific basis for the development of new approaches to treat CIPN.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling pain condition that involves structural and functional impairment of peripheral motor, sensory, and autonomic neurons. CIPN symptoms may involve a combination of motor, sensory, and autonomic deficits. Sensory symptoms are the most common and are usually the first to appear, affecting the hands and feet the most. Sensory symptoms usually manifest as spontaneous or induced abnormal sensations, such as abnormal sensation, sensory dullness, numbness, burning, shooting or electric shock sensations, and unusual pain or pain hypersensitivity induced by mechanical or thermal stimuli. Paclitaxel drugs are among the most commonly used neurotoxic chemotherapeutic agents. In the absence of effective conventional treatments, there are limited effective ways to prevent or treat CIPN. The traditional Chinese medicine, Moutan Cortex, has long been used for its anticoagulant, anti-inflammatory, analgesic, and sedative activities, as well as for the treatment of cardiovascular, hemorrhagic, stagnated blood, and female genital disorders. Studies have shown that paeonol, a major component of Moutan Cortex, has analgesic, antipyretic and antibacterial properties, as well as anti-inflammatory, antioxidant and anti-platelet aggregation effects. It has a wide range of properties, such as inhibiting collagen-induced platelet aggregation and attenuating inflammatory responses in airways, coronary arteries, macrophages and microglia. Preliminary results in a baseline study showed that intraperitoneal administration of paclitaxel reduced the mechanical nociceptive threshold in the hind palm, indicating increased sensitivity to painful stimuli (mechanical allodynia pain). In contrast, the reduction in mechanical nociceptive threshold in the hind palm induced by paclitaxel was significantly reversed after oral administration of different doses of dandruff and approached that of the control group without paclitaxel, showing a significant improvement in mechanical anomalous pain. Therefore, a randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. This research project will validate our new preliminary findings demonstrating the neuroprotective effects after paclitaxel treatment. Importantly, our data are expected to elucidate the way Moutan Cortex induces neuroprotection in the clinical setting and provide a scientific basis for the development of new approaches to treat CIPN.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moutan cortex group | Experimental | Drug: Moutan cortexMoutan Cortex, the certified pharmaceutical name is "Moutan radices extract power". The purchased powder is manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan (No. 0714A) and standardized with a standard product of Moutan Cortex certified by Taiwan Food and Drug Administration (certified no. 003053). Each participant will intake moutan cortex 2g/day daily for 4 weeks. |
| Sham Moutan cortex group | Sham comparator | Drug: sham moutan cortexThe sham Moutan cortex powder will also be manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan. Each participant will intake sham moutan cortex 2g/day daily for 4 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult women above 20 years, diagnosed with stage I-III breast cancer by a histological analysis, and who had completed adjuvant or neoadjuvant neurotoxic chemotherapy (including taxane-based or platinum-based), with the severity of CIPN matching the definition of the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 version more than grade 1. In addition, the patients' daily physical status will match the definition of the Eastern Cooperative Oncology Group (ECOG) performance status less than grade 3
Key exclusion criteria (1 listed)
- metastatic breast cancer, a history of diabetic neurological disease before chemotherapy, other pre-existing peripheral neurological disorders, a history of inflammatory or metabolic arthritis, severe coagulopathy or potential bleeding tendency, dermatological disease within acupuncture needling area. Concomitant use of selected analgesics was allowed23 (e.g.,opioids, acetaminophen, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs]), but only patients receiving stable doses in the two weeks prior to randomization could participate: 1) no new analgesics were added; 2) no analgesics were discontinued; and 3) the weekly 24-hour total analgesic dose did not fluctuate up or down by > 10% in the two weeks prior to study registration
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 |
|---|---|---|
| Moutan cortexMoutan Cortex, the certified pharmaceutical name is "Moutan radices extract power". The purchased powder is manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan (No. 0714A) and standardized with a standard product of Moutan Cortex certified by Taiwan Food and Drug Administration (certified no. 003053). | Drug | Moutan cortex group |
| sham moutan cortexThe sham Moutan cortex powder will also be manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan. Each participant will intake sham moutan cortex 2g/day daily for 4 weeks. | Drug | Sham Moutan cortex group |
Primary outcome
BPI-SF;the Brief Pain Inventory-Short Form
Time frame: BPI-SF will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form24 (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.
2 secondary outcomes
SWM
Time frame: SWM will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)
The 13-item FACT/GOG-Ntx subscale
Time frame: FACT/GOG-Ntx subscale will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 6412397Hirai A, Terano T, Hamazaki T, Sajiki J, Saito H, Tahara K, Tamura Y, Kumagai A. Studies on the mechanism of antiaggregatory effect of Moutan Cortex. Thromb Res. 1983 Jul 1;31(1):29-40. doi: 10.1016/0049-3848(83)90005-1.
- Background: PubMed 28925884Hu LY, Mi WL, Wu GC, Wang YQ, Mao-Ying QL. Prevention and Treatment for Chemotherapy-Induced Peripheral Neuropathy: Therapies Based on CIPN Mechanisms. Curr Neuropharmacol. 2019;17(2):184-196. doi: 10.2174/1570159X15666170915143217.
- Background: PubMed 28590441Wang Z, He C, Peng Y, Chen F, Xiao P. Origins, Phytochemistry, Pharmacology, Analytical Methods and Safety of Cortex Moutan (Paeonia suffruticosa Andrew): A Systematic Review. Molecules. 2017 Jun 7;22(6):946. doi: 10.3390/molecules22060946.
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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 study testing Moutan cortex in people with Breast Cancer and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Taiwan Municipal An-Nan Hospital-China Medical University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
BPI-SF;the Brief Pain Inventory-Short Form (time frame: BPI-SF will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)). 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 NCT07693374, which also lists 3 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 9 Jul 2026.