Chemotherapy-Induced Peripheral Neuropathy (CIPN)NCT06889129
Heat and Cold Therapy for Chemotherapy-Induced Neuropathy
A study testing Experimental- Heat application and Experimental-Cold application in people with Chemotherapy-Induced Peripheral Neuropathy (CIPN), run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Experimental- Heat application and Experimental-Cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 16 Jul 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with stage III-IV breast cancer receiving 4-7 cycles of taxane-based chemotherapy,
- Patients with chemotherapy-induced neuropathy symptoms,
- Residents of Ankara,
- Over 18 years older,
- No history of nerve damage or psychiatric illness,
- No central nervous system metastasis or disease,
Show all 11Show fewer
- No irritation or ulceration in the skin area where the application will be made,
- No history of deep vein thrombosis,
- Not using anticoagulant medication,
- Able to speak, understand, and read/write in Turkish,
- Patients who consent to participate in the study will be included.
Who cannot join
- Patients with a history of nerve damage or psychiatric illness,
- Ulcers or irritation in the area where the application will be made,
- Patients with peripheral neuropathy developed due to reasons other than chemotherapy,
- Patients who do not consent to participate in the study will be excluded.
- Patients whose taxane treatment protocol is changed,
- Patients who have less than four applications per week will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Education and Research Hospital
Ankara, 06010
About this study
Official title: Effect of Local Heat and Cold Application in the Management of Peripheral Neuropathy in Breast Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
Cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. The development of neuropathy not only restricts patients' physical functions but may also lead to dose reduction or even the discontinuation of chemotherapy.
Among chemotherapeutic agents, taxanes are among the most common causes of neuropathy. Docetaxel and paclitaxel, which belong to the taxane group, are widely used chemotherapeutics in the treatment of breast cancer. The degeneration, which manifests as numbness, tingling, and burning sensations in the fingers and toes, progresses from the distal to the proximal end of peripheral nerve axons.
Read more
Although several potential agents have been clinically tested to prevent CIPN, no pharmacological agent other than duloxetine, which has limited efficacy, has been proven effective. A review of the literature reveals that non-pharmacological methods used in the management of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS), massage, exercise, heat and cold application, relaxation techniques, acupuncture, and reflexology. Studies investigating the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is effective in managing neuropathic symptoms.
This randomized controlled trial aims to evaluate the effects of local heat and cold application on neuropathic symptoms in breast cancer patients undergoing chemotherapy. Data will be collected using the Patient Information Form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and the Heat and Cold Application Patient Follow-up Form. Assessments will be conducted in both the intervention and control groups before the intervention and at the end of a 4-week period.
This study is designed as a randomized controlled trial to determine the effects of local heat and cold application on neuropathy in patients with chemotherapy-induced peripheral neuropathy.
Read the detailed description
Breast cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. The most common side effects include neutropenia, anemia, peripheral neuropathy, nausea, vomiting, diarrhea, constipation, and fatigue. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. CIPN can develop either during or after chemotherapy and not only restricts patients' physical functions but may also lead to dose reduction or even treatment discontinuation.
Among chemotherapeutic agents, taxanes are among the most common causes of neuropathy. Docetaxel and paclitaxel, which belong to the taxane group, are widely used chemotherapeutics in the treatment of breast cancer. The incidence of taxane-induced peripheral neuropathy varies between 61% and 92%. Although taxane-induced neuropathy primarily presents with sensory symptoms, it is a toxicity that can also affect motor and autonomic functions. The degeneration, which manifests as numbness, tingling, and burning sensations in the fingers and toes, progresses from the distal to the proximal end of peripheral nerve axons. Neuropathy in the upper extremities typically appears later.
The neurotoxicity of taxane-induced neuropathy is dose-dependent, and progression ceases once the drug treatment is completed. Emerging symptoms can be prevented by reducing the drug dose or increasing the interval between doses. However, these adjustments may significantly compromise cancer treatment outcomes. Although numerous potential agents have been clinically tested to prevent chemotherapy-induced peripheral neuropathy, no pharmacological agent other than duloxetine, which has limited efficacy, has been proven effective.
A review of the literature reveals that non-pharmacological methods used in the management of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS), massage, exercise, heat and cold application, relaxation techniques, acupuncture, and reflexology. Medical baths have been used in the treatment of inflammatory and non-inflammatory rheumatic diseases, fibromyalgia, and chronic back pain, as well as for reducing fatigue and improving sleep regulation. In particular, foot bath studies have reported that foot baths increase blood circulation through vasodilation in peripheral blood vessels, improve sensory symptoms, stimulate the sense of touch, reduce sympathetic nerve activity, enhance skin permeability, promote microcirculation in cells, and support drug therapy.
A review of the literature indicates that very few studies have investigated the effects of foot baths on the management of peripheral neuropathy in cancer patients. Studies examining the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is an effective strategy for managing neuropathic symptoms
- Being tested
- Experimental- Heat application, Experimental-Cold application
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy (CIPN), breast cancer, Heat-cold application, Non-pharmacological methods
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental- Heat applicationOther
Also called Heat application
Heat application + standard protocol=Hot Application Protocol
Hot application will start daily and continue until the completion of 4 weeks. The area will be checked for infection, scar tissue, inflammation, and incision before the application, and the procedure will be explained to the patient and their family.
The first application will be performed on the day the patient comes for chemotherapy, ensuring privacy by exposing only the application area and positioning the patient appropriately.
Patients will be asked to sit on a chair or couch with both feet immersed in a foot bath containing 5 liters of water, approximately 5 cm above their ankles, every night before bed for one month. The water temperature will be 40°C. The application will last for 30 minutes.
Patients will be advised to avoid contact with cold water, as well as the consumption of cold food and beverages.
Experimental-Cold applicationOther
Also called Cold application
Cold application + standard protocol=Cold application will start daily and continue until the completion of 4 weeks.
The area will be checked for infection, scar tissue, inflammation, and incision before the application, and the procedure will be explained to the patient and their family.
The first application will be performed on the day the patient comes for chemotherapy, ensuring privacy by exposing only the application area and positioning the patient appropriately.
Patients will be asked to sit on a chair or couch with both feet immersed in a foot bath containing 5 liters of water, approximately 5 cm above their ankles, every night before bed for one month. The water temperature will be between 23-26°C. The application will be performed by the researcher on the day the patient comes for weekly chemotherapy treatment.
Patients will be advised to avoid contact with hot water, as well as the consumption of hot food and beverages.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | standard protocol=Patients in this arm will receive standard care without any additional interventions related to heat or cold application. |
| Intervention group | Experimental | Cold-Heat application + standard protocol Receives: Other: Experimental- Heat application; Other: Experimental-Cold application |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
The Turkish validity and reliability of the scale were tested in breast cancer patients receiving taxane chemotherapy (n=430). The first section assesses sensory and motor symptoms (numbness, itching, burning, discomfort, cold sensitivity, pain, weakness, balance problems), with responses scored from 0 to 10. Higher scores indicate greater discomfort. In the second section, difficulties in daily activities (e.g., dressing, walking, working, exercising) are also rated from 0 to 10. The scale's overall Cronbach alpha is 0.87, with test-retest reliability ranging from 0.90 to 0.96. These results confirm that the scale is valid and reliable for the Turkish population.
Measured: At baseline (first visit) and at 4 weeks
Local Heat and Cold Application Patient Follow-up Form
This form is designed to assess patients' adherence to local heat or cold application. During the heat or cold application process, patients will be followed up by phone to enhance their adherence to the program and ensure compliance. In addition, when patients come to receive their weekly chemotherapy doses, the application will be performed by the researcher.
Patients will mark their heat or cold application status on the form while performing the application at home. The forms will be reviewed by the researcher when patients visit the hospital for chemotherapy treatment. Patients who perform the application less than four times per week will not be included in the evaluation.
Measured: At baseline (first visit) and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start3 Mar 2025
- Primary completion10 May 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral Neuropathy (CIPN)Studies 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
- Model description
- The study population will consist of breast cancer patients receiving taxane-based chemotherapy at the Daytime Chemotherapy Unit of a training and research hospital who meet the inclusion criteria. The sample size calculation was performed for the study. Before conducting the power analysis, the effect size needed to be determined. In this study, the effect size was derived from a similar previous study. Considering a Type I error (α) = 0.05 and Power (1-β) = 0.90, the effect size (d) was selected as 0.35 based on a one-way analysis of variance (ANOVA). Using G\*Power 3.1.9.7, the minimum required sample size was calculated as 108 participants. Based on these parameters, the expected minimum sample size is 36 patients per group, with a total of 108 participants. However, considering potential dropouts during the study, a total of 114 patients are planned to be included.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahat Coşkun, Bilecik Seyh Edebali Universitesi
- Investigators
- SABAHAT COŞKUN, Doç.Dr., Study director, Bilecik Şeyh Edebali Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889129
- Sponsor's protocol ID
- Bilecik16
- Status last verified
- Jul 2025
- First submitted
- 15 Mar 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon request, in accordance with ethical guidelines and with participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Heat and Cold Application in the Management of Peripheral Neuropathy in Breast Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06889129
- Acronym / sponsor ID
- Bilecik16
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy (CIPN), breast cancer, Heat-cold application, Non-pharmacological methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 21 Mar 2025 (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.
Cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. The development of neuropathy not only restricts patients' physical functions but may also lead to dose reduction or even the discontinuation of chemotherapy.
Among chemotherapeutic agents, taxanes are among the most common causes of neuropathy. Docetaxel and paclitaxel, which belong to the taxane group, are widely used chemotherapeutics in the treatment of breast cancer. The degeneration, which manifests as numbness, tingling, and burning sensations in the fingers and toes, progresses from the distal to the proximal end of peripheral nerve axons.
Although several potential agents have been clinically tested to prevent CIPN, no pharmacological agent other than duloxetine, which has limited efficacy, has been proven effective. A review of the literature reveals that non-pharmacological methods used in the management of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS), massage, exercise, heat and cold application, relaxation techniques, acupuncture, and reflexology. Studies investigating the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is effective in managing neuropathic symptoms.
This randomized controlled trial aims to evaluate the effects of local heat and cold application on neuropathic symptoms in breast cancer patients undergoing chemotherapy. Data will be collected using the Patient Information Form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and the Heat and Cold Application Patient Follow-up Form. Assessments will be conducted in both the intervention and control groups before the intervention and at the end of a 4-week period.
This study is designed as a randomized controlled trial to determine the effects of local heat and cold application on neuropathy in patients with chemotherapy-induced peripheral neuropathy.
Detailed description
Breast cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. The most common side effects include neutropenia, anemia, peripheral neuropathy, nausea, vomiting, diarrhea, constipation, and fatigue. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. CIPN can develop either during or after chemotherapy and not only restricts patients' physical functions but may also lead to dose reduction or even treatment discontinuation.
Among chemotherapeutic agents, taxanes are among the most common causes of neuropathy. Docetaxel and paclitaxel, which belong to the taxane group, are widely used chemotherapeutics in the treatment of breast cancer. The incidence of taxane-induced peripheral neuropathy varies between 61% and 92%. Although taxane-induced neuropathy primarily presents with sensory symptoms, it is a toxicity that can also affect motor and autonomic functions. The degeneration, which manifests as numbness, tingling, and burning sensations in the fingers and toes, progresses from the distal to the proximal end of peripheral nerve axons. Neuropathy in the upper extremities typically appears later.
The neurotoxicity of taxane-induced neuropathy is dose-dependent, and progression ceases once the drug treatment is completed. Emerging symptoms can be prevented by reducing the drug dose or increasing the interval between doses. However, these adjustments may significantly compromise cancer treatment outcomes. Although numerous potential agents have been clinically tested to prevent chemotherapy-induced peripheral neuropathy, no pharmacological agent other than duloxetine, which has limited efficacy, has been proven effective.
A review of the literature reveals that non-pharmacological methods used in the management of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS), massage, exercise, heat and cold application, relaxation techniques, acupuncture, and reflexology. Medical baths have been used in the treatment of inflammatory and non-inflammatory rheumatic diseases, fibromyalgia, and chronic back pain, as well as for reducing fatigue and improving sleep regulation. In particular, foot bath studies have reported that foot baths increase blood circulation through vasodilation in peripheral blood vessels, improve sensory symptoms, stimulate the sense of touch, reduce sympathetic nerve activity, enhance skin permeability, promote microcirculation in cells, and support drug therapy.
A review of the literature indicates that very few studies have investigated the effects of foot baths on the management of peripheral neuropathy in cancer patients. Studies examining the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is an effective strategy for managing neuropathic symptoms
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population will consist of breast cancer patients receiving taxane-based chemotherapy at the Daytime Chemotherapy Unit of a training and research hospital who meet the inclusion criteria. The sample size calculation was performed for the study. Before conducting the power analysis, the effect size needed to be determined. In this study, the effect size was derived from a similar previous study. Considering a Type I error (α) = 0.05 and Power (1-β) = 0.90, the effect size (d) was selected as 0.35 based on a one-way analysis of variance (ANOVA). Using G*Power 3.1.9.7, the minimum required sample size was calculated as 108 participants. Based on these parameters, the expected minimum sample size is 36 patients per group, with a total of 108 participants. However, considering potential dropouts during the study, a total of 114 patients are planned to be included.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –standard protocol=Patients in this arm will receive standard care without any additional interventions related to heat or cold application. |
| Intervention group | Experimental | Other: Experimental- Heat application, Other: Experimental-Cold applicationCold-Heat application + standard protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women with stage III-IV breast cancer receiving 4-7 cycles of taxane-based chemotherapy,
- Patients with chemotherapy-induced neuropathy symptoms,
- Residents of Ankara,
- Over 18 years older,
- No history of nerve damage or psychiatric illness,
Key exclusion criteria (6 listed)
- Patients with a history of nerve damage or psychiatric illness,
- Ulcers or irritation in the area where the application will be made,
- Patients with peripheral neuropathy developed due to reasons other than chemotherapy,
- Patients who do not consent to participate in the study will be excluded.
- Patients whose taxane treatment protocol is changed,
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 |
|---|---|---|
| Experimental- Heat applicationAlso: Heat applicationHeat application + standard protocol=Hot Application Protocol Hot application will start daily and continue until the completion of 4 weeks. The area will be checked for infection, scar tissue, inflammation, and incision before the application, and the procedure will be explained to the patient and their family. The first application will be performed on the day the patient comes for chemotherapy, ensuring privacy by exposing only the application area and positioning the patient appropriately. Patients will be asked to sit on a chair or couch with both feet immersed in a foot bath containing 5 liters of water, approximately 5 cm above their ankles, every night before bed for one month. The water temperature will be 40°C. The application will last for 30 minutes. Patients will be advised to avoid contact with cold water, as well as the consumption of cold food and beverages. | Other | Intervention group |
| Experimental-Cold applicationAlso: Cold applicationCold application + standard protocol=Cold application will start daily and continue until the completion of 4 weeks. The area will be checked for infection, scar tissue, inflammation, and incision before the application, and the procedure will be explained to the patient and their family. The first application will be performed on the day the patient comes for chemotherapy, ensuring privacy by exposing only the application area and positioning the patient appropriately. Patients will be asked to sit on a chair or couch with both feet immersed in a foot bath containing 5 liters of water, approximately 5 cm above their ankles, every night before bed for one month. The water temperature will be between 23-26°C. The application will be performed by the researcher on the day the patient comes for weekly chemotherapy treatment. Patients will be advised to avoid contact with hot water, as well as the consumption of hot food and beverages. | Other | Intervention group |
Primary outcome
1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
Time frame: At baseline (first visit) and at 4 weeks
The Turkish validity and reliability of the scale were tested in breast cancer patients receiving taxane chemotherapy (n=430). The first section assesses sensory and motor symptoms (numbness, itching, burning, discomfort, cold sensitivity, pain, weakness, balance problems), with responses scored from 0 to 10. Higher scores indicate greater discomfort. In the second section, difficulties in daily activities (e.g., dressing, walking, working, exercising) are also rated from 0 to 10. The scale's overall Cronbach alpha is 0.87, with test-retest reliability ranging from 0.90 to 0.96. These results confirm that the scale is valid and reliable for the Turkish population.
Local Heat and Cold Application Patient Follow-up Form
Time frame: At baseline (first visit) and at 4 weeks
This form is designed to assess patients' adherence to local heat or cold application. During the heat or cold application process, patients will be followed up by phone to enhance their adherence to the program and ensure compliance. In addition, when patients come to receive their weekly chemotherapy doses, the application will be performed by the researcher. Patients will mark their heat or cold application status on the form while performing the application at home. The forms will be reviewed by the researcher when patients visit the hospital for chemotherapy treatment. Patients who perform the application less than four times per week will not be included in the evaluation.
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 18 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon request, in accordance with ethical guidelines and with participant consent.
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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.
SABAHAT COŞKUN, Doç.Dr. study director
Bilecik Şeyh Edebali Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental- Heat application and Experimental-Cold application in people with Chemotherapy-Induced Peripheral Neuropathy (CIPN), run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
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 11 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 18 Jul 2025. 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 Turkey (Türkiye). 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.
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?
1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) (time frame: At baseline (first visit) and at 4 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?
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 18 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.