Doxorubicin Induced CardiotoxicityPhase 2NICBREASTRCTNCT07897409
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
A Phase 2 study testing Nicorandil Oral Tablet and Adriamycin (Doxorubicin) in people with Doxorubicin Induced Cardiotoxicity and Doxorubicin Induced Cardiomyopathy, run by Universiti Sains Malaysia at 1 site in Egypt.
Trial summary
Breast cancer is one of the world's most common cancers in females. Most of the chemotherapy protocols used to treat breast cancer involve doxorubicin. Doxorubicin has a very significant antitumor effect on breast tumors. One of the obstacles that hinders the use of doxorubicin is cardiotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy, Doxorubicin
- What is being tested?
- Nicorandil Oral Tablet and Adriamycin (Doxorubicin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2026to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years - 65 years
- Female patients with stage (I, II, III) breast cancer.
- Left ventricular ejection fraction (LVEF) ≥ 55% upon breast cancer diagnosis.
- Systolic blood pressure ≥ 90 mmHg
- Estimated glomerular filtration rate (eGFR ≥ 60 mL/min per 1.73 m²). Exclusion criteria
- Pregnant and lactating mothers.
Show all 13Show fewer
- Metastatic breast cancer. (stage IV).
- Patients are currently using beta-blockers and phosphodiesterase 5 inhibitors.
- Patients who require chronic use of aspirin or chronic use of corticosteroids (≥3 months).
- Patients who are diagnosed with heart failure, myocardial infarction, stable angina, cardiogenic shock, hypovolemia, or previous coronary revascularization.
- Previously treated with anthracyclines.
- Previous gastrointestinal bleeding, ulcer, or perforation.
- Severe hepatic impairment (ALT, AST ≥ 5 upper limit normal), or diagnosed with clinical evidence of hepatic ascites, encephalopathy, variceal bleeding, decompensated cirrhosis, and acute hepatitis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
National Cancer Institute
Cairo, Cairo Governorate
Noha S Abdelaziz, Phd, 00201012305323, nohasalahphr.ct@gmail.com
About this study
Official title: The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity, Including Quality of Life and Cost Analysis Among Breast Cancer Patients at Breast Cancer Hospital: A Randomized Controlled Trial in Egypt
Breast cancer is one of the world's most common cancers in females. Most of the chemotherapy protocols used to treat breast cancer involve doxorubicin. Doxorubicin has a very significant antitumor effect on breast tumors. One of the obstacles that hinders the use of doxorubicin is cardiotoxicity. Although many agents are used to address this issue, only dexrazoxane is FDA-approved. One suggested pathway for doxorubicin-induced cardiotoxicity is due to calcium imbalance. Calcium ions are very important in controlling the heart's function. Nicorandil is an anti-anginal agent that shows cardioprotective effects against doxorubicin-induced cardiotoxicity in preclinical trials. Not only that, but preclinical studies on rats and mice have also shown that it has antitumor and augmenting effects on doxorubicin's anticancer properties. Here in our trial, the impact of the nicorandil will be assessed on breast cancer patients. The chosen method will be a parallel, open-label, randomized clinical trial. The selected sampling method will be stratified blocks based on radiotherapy and HFA-ICOS baseline scores. The sample size will be 146 patients, who will be randomized using a premuted block. The primary parameter will be the ejection fraction. The secondary parameters will include cardiac troponins, creatine kinase myocardial band, safety assessment of nicorandil use on the gastrointestinal and cardiovascular systems, quality of life after nicorandil use, cost-effectiveness and cost-utility of nicorandil, and the quality of life and baseline cardiac scoring system.
Read the detailed description
There are different modalities for the treatment of breast cancer, including surgery, chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy. Chemotherapy is important to decrease the tumor size of the breast, making breast conservation possible.
Doxorubicin (DOX) is an anticancer agent used in chemotherapy to treat hematological and solid cancers. In breast cancer, DOX is used in many protocols. One of the well-known chemotherapeutic protocols is AC-T (adriamycin, cyclophosphamide, and paclitaxel). The mechanism of DOX cytotoxicity is due to free radical formation, which is associated with DOX cardiotoxic adverse events. DOX-induced cardiomyopathy leads to fibrosis of myocardial cells that causes cardiovascular disorders. DOX-cardiotoxicity is considered irreversible (type I) cardiotoxicity. Echocardiography remains the gold standard for assessing cardiac function primarily by evaluating the left ventricular ejection fraction (LVEF). Besides, echocardiography could assess the global longitudinal strain (GLS), a measure of the left ventricle's longitudinal shortening, which is more sensitive for detecting early myocardial dysfunction that cannot be assessed by LVEF alone. Changes in GLS can indicate subclinical cardiac impairment, which is considered an early warning sign of doxorubicin-induced cardiotoxicity.
Biomarkers of cardiotoxicity are a non-invasive method for early detection in patients undergoing doxorubicin therapy. These biomarkers enable clinicians to initiate preventive treatment regimens earlier, as they indicate long-term LVEF deterioration. Studies have shown that the risk of DOX cardiotoxicity increases at a cumulative dose of 400 mg/m² without other risk factors. DOX-induced cardiotoxicity may lead to increased morbidity and mortality.
As a consequence, for most of the patients with DOX-induced cardiotoxicity, their quality of life will be affected. One of the methods used for quality of life assessment is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) Core 30 (QLQ-C30), and another one for breast cancer patients (BR-42). A study has shown the deterioration in the psychological and physical state of breast cancer patients on chemotherapy treatment.
Many antioxidant supplements are used to treat DOX-induced cardiotoxicity. Dexrazoxane is the only FDA-approved cardioprotective agent for DOX cardiotoxicity. Although other supplements like omega-3, vitamin E, and levocarnitine have shown significant effects in preclinical studies, only a few have been investigated in clinical practice. Yet, few studies have targeted the Ca²⁺ imbalance caused by DOX administration.
Nicorandil (NIC), a nicotinamide ester with a nitrate group, is used in several medical conditions in Japan and Europe. Nicorandil's (NIC) cardioprotective effect was caused by selective activation of the mitochondrial ATP-sensitive K+ channel (mitoKATP) and nitric oxide (NO) donor activity. These will lead to cardiac muscle relaxation and decrease reactive oxygen species and cell death. They also maintain calcium homeostasis and prevent high intracellular calcium levels, which can cause cellular malfunction and apoptosis.
Available studies show promising results for NIC in patients with heart failure. Preclinical studies suggested that NIC may also have a protective effect against DOX-induced cardiotoxicity by avoiding mitochondrial dysfunction without affecting the antitumor activity of DOX. Further clinical studies are needed to confirm the protective effect of NIC against DOX-induced cardiotoxicity.
- Conditions
- Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy, Doxorubicin, Doxorubicin Adverse Reaction
- Being tested
- Nicorandil Oral Tablet, Adriamycin (Doxorubicin)
- Keywords
- doxorubicin, cardiomyopathy, cardiotoxicity, nicorandil
- Medical subject headings
- Cardiomyopathies, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil Oral TabletDrug
Also called NIC
drug
Adriamycin (Doxorubicin)Drug
Also called DOX, AC-T PROTCOL
AC regimen (doxorubicin 60 mg/m2 intravenous every 21 days, cyclophosphamide 600 mg/m2 intravenous every 21 days for 4 cycles).
| Study group | Role | What they receive |
|---|---|---|
| STANDARD CARE | Active comparator | DOX protocol AC regimen (doxorubicin 60 mg/m2 intravenous every 21 days, cyclophosphamide 600 mg/m2 intravenous every 21 days for 4 cycles). Receives: Drug: Adriamycin (Doxorubicin) |
| Treatment | Experimental | NIC ( 5-10 mg per day ) + DOX protcol Receives: Drug: Nicorandil Oral Tablet; Drug: Adriamycin (Doxorubicin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of nicorandil on left ventricular ejection fraction in breast cancer patients receiving doxorubicin.
Elevation or maintenance of Ejection fraction percentage (EF %) using echocardiogram
Measured: before the treatment initiation, at the 3rd and the 6th months of the treatment initiation
To evaluate the safety of nicorandil
possible hypotension (mmhg)
Measured: before the treatment initiation, at the 3rd and the 6th months of the treatment initiation
Secondary outcomes (4)
To assess patients' quality of life
using the modified EORTC QLQ-BR42, where 100 is the best quality and 0 is the worst.
Measured: From enrollment, at the 3rd and the 6th months of the treatment
To determine the effect of nicorandil on global longitudinal strain in breast cancer patients receiving doxorubicin.
by using echogradiogram in %
Measured: From enrollment and at the 3rd and the 6th months of treatment
To evaluate the cost-utility of nicorandil as a cardioprotective agent against doxorubicin-induced cardiotoxicity.
using the QALY unit
Measured: at the treatment initiation, the 3rd and the 6th months of the treament
To assess the effect of nicorandil on cardiac biomarkers
by assessing, including cardiac troponin ng/ml
Measured: at the treatment initiation, at the 3rd and 6th months of the treament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
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 Doxorubicin Induced CardiotoxicityStudies 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
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Salah Ahmed Abdelaziz, Universiti Sains Malaysia
- Investigators
- Noha S Abdelaziz, PhD, Principal investigator, Universiti Sains MalaysiaSabariah N H, Ass.Prof, Principal investigator, Universiti Sains MalaysiaAyman A G, Prof, Principal investigator, National Cancer Institute (NCI)Nur H Md, lecturer, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897409
- Sponsor's protocol ID
- NIC in DOX Cardiotoxicity
- Acronym
- NICBREASTRCT
- Status last verified
- Nov 2026
- First submitted
- 3 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
PubMed 25328522References: 2. Cuthrell KM, Tzenios N. Breast Cancer: Updated and Deep Insights. International Research Journal of Oncology. 2023;6(1):104-18.
Obeagu EI, Obeagu GU. Breast cancer: A review of risk factors and diagnosis. Medicine (Baltimore). 2024 Jan 19;103(3):e36905. doi: 10.1097/MD.0000000000036905.
PubMed 38241592
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity, Including Quality of Life and Cost Analysis Among Breast Cancer Patients at Breast Cancer Hospital: A Randomized Controlled Trial in Egypt
- ClinicalTrials.gov ID
- NCT07897409
- Acronym / sponsor ID
- NICBREASTRCT / NIC in DOX Cardiotoxicity
- Conditions
- Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy, Doxorubicin, Doxorubicin Adverse Reaction
- Keywords
- doxorubicin, cardiomyopathy, cardiotoxicity, nicorandil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Oct 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.
Breast cancer is one of the world's most common cancers in females. Most of the chemotherapy protocols used to treat breast cancer involve doxorubicin. Doxorubicin has a very significant antitumor effect on breast tumors. One of the obstacles that hinders the use of doxorubicin is cardiotoxicity. Although many agents are used to address this issue, only dexrazoxane is FDA-approved. One suggested pathway for doxorubicin-induced cardiotoxicity is due to calcium imbalance. Calcium ions are very important in controlling the heart's function. Nicorandil is an anti-anginal agent that shows cardioprotective effects against doxorubicin-induced cardiotoxicity in preclinical trials. Not only that, but preclinical studies on rats and mice have also shown that it has antitumor and augmenting effects on doxorubicin's anticancer properties. Here in our trial, the impact of the nicorandil will be assessed on breast cancer patients. The chosen method will be a parallel, open-label, randomized clinical trial. The selected sampling method will be stratified blocks based on radiotherapy and HFA-ICOS baseline scores. The sample size will be 146 patients, who will be randomized using a premuted block. The primary parameter will be the ejection fraction. The secondary parameters will include cardiac troponins, creatine kinase myocardial band, safety assessment of nicorandil use on the gastrointestinal and cardiovascular systems, quality of life after nicorandil use, cost-effectiveness and cost-utility of nicorandil, and the quality of life and baseline cardiac scoring system.
Detailed description
There are different modalities for the treatment of breast cancer, including surgery, chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy. Chemotherapy is important to decrease the tumor size of the breast, making breast conservation possible.
Doxorubicin (DOX) is an anticancer agent used in chemotherapy to treat hematological and solid cancers. In breast cancer, DOX is used in many protocols. One of the well-known chemotherapeutic protocols is AC-T (adriamycin, cyclophosphamide, and paclitaxel). The mechanism of DOX cytotoxicity is due to free radical formation, which is associated with DOX cardiotoxic adverse events. DOX-induced cardiomyopathy leads to fibrosis of myocardial cells that causes cardiovascular disorders. DOX-cardiotoxicity is considered irreversible (type I) cardiotoxicity. Echocardiography remains the gold standard for assessing cardiac function primarily by evaluating the left ventricular ejection fraction (LVEF). Besides, echocardiography could assess the global longitudinal strain (GLS), a measure of the left ventricle's longitudinal shortening, which is more sensitive for detecting early myocardial dysfunction that cannot be assessed by LVEF alone. Changes in GLS can indicate subclinical cardiac impairment, which is considered an early warning sign of doxorubicin-induced cardiotoxicity.
Biomarkers of cardiotoxicity are a non-invasive method for early detection in patients undergoing doxorubicin therapy. These biomarkers enable clinicians to initiate preventive treatment regimens earlier, as they indicate long-term LVEF deterioration. Studies have shown that the risk of DOX cardiotoxicity increases at a cumulative dose of 400 mg/m² without other risk factors. DOX-induced cardiotoxicity may lead to increased morbidity and mortality.
As a consequence, for most of the patients with DOX-induced cardiotoxicity, their quality of life will be affected. One of the methods used for quality of life assessment is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) Core 30 (QLQ-C30), and another one for breast cancer patients (BR-42). A study has shown the deterioration in the psychological and physical state of breast cancer patients on chemotherapy treatment.
Many antioxidant supplements are used to treat DOX-induced cardiotoxicity. Dexrazoxane is the only FDA-approved cardioprotective agent for DOX cardiotoxicity. Although other supplements like omega-3, vitamin E, and levocarnitine have shown significant effects in preclinical studies, only a few have been investigated in clinical practice. Yet, few studies have targeted the Ca²⁺ imbalance caused by DOX administration.
Nicorandil (NIC), a nicotinamide ester with a nitrate group, is used in several medical conditions in Japan and Europe. Nicorandil's (NIC) cardioprotective effect was caused by selective activation of the mitochondrial ATP-sensitive K+ channel (mitoKATP) and nitric oxide (NO) donor activity. These will lead to cardiac muscle relaxation and decrease reactive oxygen species and cell death. They also maintain calcium homeostasis and prevent high intracellular calcium levels, which can cause cellular malfunction and apoptosis.
Available studies show promising results for NIC in patients with heart failure. Preclinical studies suggested that NIC may also have a protective effect against DOX-induced cardiotoxicity by avoiding mitochondrial dysfunction without affecting the antitumor activity of DOX. Further clinical studies are needed to confirm the protective effect of NIC against DOX-induced cardiotoxicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD CARE | Active comparator | Drug: Adriamycin (Doxorubicin)DOX protocol AC regimen (doxorubicin 60 mg/m2 intravenous every 21 days, cyclophosphamide 600 mg/m2 intravenous every 21 days for 4 cycles). |
| Treatment | Experimental | Drug: Nicorandil Oral Tablet, Drug: Adriamycin (Doxorubicin)NIC ( 5-10 mg per day ) + DOX protcol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years - 65 years
- Female patients with stage (I, II, III) breast cancer.
- Left ventricular ejection fraction (LVEF) ≥ 55% upon breast cancer diagnosis.
- Systolic blood pressure ≥ 90 mmHg
- Estimated glomerular filtration rate (eGFR ≥ 60 mL/min per 1.73 m²). Exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nicorandil Oral TabletAlso: NICdrug | Drug | Treatment |
| Adriamycin (Doxorubicin)Also: DOX, AC-T PROTCOLAC regimen (doxorubicin 60 mg/m2 intravenous every 21 days, cyclophosphamide 600 mg/m2 intravenous every 21 days for 4 cycles). | Drug | STANDARD CARE, Treatment |
Primary outcome
To evaluate the effect of nicorandil on left ventricular ejection fraction in breast cancer patients receiving doxorubicin.
Time frame: before the treatment initiation, at the 3rd and the 6th months of the treatment initiation
Elevation or maintenance of Ejection fraction percentage (EF %) using echocardiogram
To evaluate the safety of nicorandil
Time frame: before the treatment initiation, at the 3rd and the 6th months of the treatment initiation
possible hypotension (mmhg)
4 secondary outcomes
To assess patients' quality of life
Time frame: From enrollment, at the 3rd and the 6th months of the treatment
To determine the effect of nicorandil on global longitudinal strain in breast cancer patients receiving doxorubicin.
Time frame: From enrollment and at the 3rd and the 6th months of treatment
To evaluate the cost-utility of nicorandil as a cardioprotective agent against doxorubicin-induced cardiotoxicity.
Time frame: at the treatment initiation, the 3rd and the 6th months of the treament
To assess the effect of nicorandil on cardiac biomarkers
Time frame: at the treatment initiation, at the 3rd and 6th months of the treament
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 25328522Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
- BackgroundReferences: 2. Cuthrell KM, Tzenios N. Breast Cancer: Updated and Deep Insights. International Research Journal of Oncology. 2023;6(1):104-18.
- Background: PubMed 38241592Obeagu EI, Obeagu GU. Breast cancer: A review of risk factors and diagnosis. Medicine (Baltimore). 2024 Jan 19;103(3):e36905. doi: 10.1097/MD.0000000000036905.
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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.
Noha S Abdelaziz, PhD principal investigator
Universiti Sains Malaysia
Sabariah N H, Ass.Prof principal investigator
Universiti Sains Malaysia
Ayman A G, Prof principal investigator
National Cancer Institute (NCI)
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 Nicorandil Oral Tablet and Adriamycin (Doxorubicin) in people with Doxorubicin Induced Cardiotoxicity and Doxorubicin Induced Cardiomyopathy, run by Universiti Sains Malaysia 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 13 inclusion and 0 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: opening soon, as of the sponsor's last update on 3 Nov 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha S A, Phd (00201012305323, nohasalahphr.ct@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of nicorandil on left ventricular ejection fraction in breast cancer patients receiving doxorubicin. (time frame: before the treatment initiation, at the 3rd and the 6th months of the treatment initiation). 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 NCT07897409, 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 3 Nov 2026.