Head and Neck CancerPhase 2NCT03101514
Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study
A Phase 2 study testing Kanglaite and chemotherapy in people with Head and Neck Cancer and Radiotherapy, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
About 89%-100% patients with head and neck malignant tumors have radiation mucositis during their radiotherapy. Until now, there is no effective method to prevent mucositis. Steroid hormone, pain-relief, anti-inflammatory and other symptom-relief treatments usually are used after the emergence of mucositis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy
- What is being tested?
- Kanglaite and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old, expected survival period ≥ 12 months
- Karnofsky score ≥80 points
- Pathological confirmed head and neck malignant tumors (oral, oropharynx, hypopharynx, throat, nasopharynx, nasal paranasal sinus or other), radical radiotherapy (± chemotherapy) or postoperative radiotherapy (± chemotherapy), radiotherapy dose 60 -70Gy
- with or without induction chemotherapy (induced chemotherapy ≤ 3 cycles);
- Meet the following laboratory diagnostic indicators:
- Hemoglobin ≥120g / L, white blood cells 4.0-10.0 × 109 / L, neutrophils 2.0-7.5 × 109 / L, platelets 100-300 × 109 / L; creatinine ≤ normal upper limit (UNL); ALT and AST ≤ 2.5 × UNL, alkaline phosphatase (ALP) ≤ 5 × UNL, total bilirubin (Tbil) ≤ UNL
- Sign informed consent.
Who cannot join
- Distant metastases
- Allergy to Kanglaite
- Head and neck had previously received radiation therapy
- Pregnancy or lactation patients
- Targeted drug therapy during radiotherapy
- Radio-chemotherapy uses cytotoxic drugs other than platinum
Show all 9Show fewer
- Currently active infections, or combined with rheumatic immune diseases, long-term chronic infection, acute infection, inflammatory state; hematopoietic dysfunction of the blood system diseases; severe cardiopulmonary disease
- Mental history, can not cooperate with the treatment
- Researchers believe unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
About this study
About 89%-100% patients with head and neck malignant tumors have radiation mucositis during their radiotherapy. Until now, there is no effective method to prevent mucositis. Steroid hormone, pain-relief, anti-inflammatory and other symptom-relief treatments usually are used after the emergence of mucositis. Coixenol triglyceride is an ester extract of Coix Seed. Its trade name is Kanglaite Injection, which has been approved in China and Russia. Kanglaite has anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite could also improve the quality of life of patients and mitigate the condition of the cachexia. In china, two studies evaluating treatment of Kanglaite to nasopharyngeal cancer, found that Kanglaite can reduce radiotherapy mucositis. So far, Kanglaite on the prevention and treatment of radiation mucositis of the head and neck malignant tumor is still lack of strong clinical trial evidence. This is a phase II, single center, one arm study with subject to evaluate the acute radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of head and neck cancer.
Read the detailed description
3-4 grade radiation mucositis account for 34%-56% in all head and neck patients treated by radiotherapy and >50% in patients treated by radiotherapy concurrent with chemotherapy. 3-4 grade radiation mucositis have obvious symptoms, presenting with fusion ulcers, ulcers bleeding or obvious pain need analgesic drugs. At this time, the patients can not eat or can only intake fluid diet, which led to weight loss, malnutrition, quality of life declined and a series of problems.
Kanglaite has anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite can reduce radiotherapy mucositis of nasopharyngeal cancer had been found initially in Chinese. Kanglaite on the prevention and treatment of radiation mucositis of the head and neck malignant tumor is still lack of strong clinical trial evidence. This is a phase II, single center, one arm study with subject to evaluation the acute radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of head and neck malignant tumors.
Kanglaite 200ml is injected intravenous from the first day to the last day of radiotherapy. Chemotherapy with cisplatin or nedaplatin (both 80-100mg/m2, 21 day per cycle, 1-3 cycles) is used or not concurrent with radiotherapy. There is no order of Kanglaite injection and radiotherapy. Granulocyte colony stimulating factor and antibiotics have no prophylactic use, but can be used after the decline of white blood cells. Mucositis, nutritional status, and quality of life are evaluated before radiotherapy, every week of radiotherapy, 4 weeks after radiotherapy. Mucositis is verified by physical examination. Nutritional status is evaluated by patient-generated subjective global assessment (PG-SGA) scale. Quality of life is evaluated by EORTC QLQ-C30 and QLQ-H\&N35 questionnaire.
This is a one arm study, sample size calculation based on the incidence of 3-4 degree mucositis. The incidence of 3-4 degree mucositis is about >50% according to literatures of head and neck squamous cell carcinoma intensity modulated radiation therapy concurrent with chemotherapy. So we assume that Kanglaite can reduce 3-4 degree mucositis from 50% to 30%. The sample size required 44 cases according to the superiority test, bilateral Class I error α = 0.05, class II error β = 0.2. Total 49 cases are need, assuming the off rate of 10%.
- Conditions
- Head and Neck Cancer, Radiotherapy
- Being tested
- Kanglaite, chemotherapy
- Keywords
- head and neck, tumor, radiotherapy, mucositis, toxicity, Kanglaite injection
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KanglaiteDrug
Also called Kanglaite injection
Kanglaite injection 200ml is injected intravenous from the first day to the last day of radiotherapy.
chemotherapyDrug
Also called Concurrent chemotherapy
Cisplatin 80-100mg/m2 was used every 3 weeks during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Kanglaite group | Experimental | Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy. Receives: Drug: Kanglaite; Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Incidence Rate of Severe Radiation Mucositis
The grade of radiation mucositis was assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
Measured: From date of randomization until the end radiotherapy, up to 3 months.
Secondary outcomes (5)
the Incidence Rate of Non-Hematologic Toxicity Side Events
The non-hematologic toxicity side events were assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
Measured: From date of randomization until the end radiotherapy, up to 3 months.
the Incidence Rate of Hematologic Toxicity Side Events
The grade of hematologic toxicity side events were assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
Measured: From date of randomization until the end radiotherapy, up to 3 months.
the Nutritional Status
The nutritional status was assessed by PG-SGA questionnaire.PG-SGA scores were recorded weekly during radiotherapy. A score of 0-1 indicated good nourishment, 2-8 suspected or moderate malnutrition, ≥ 9 risk of severe malnutrition.
Measured: From date of randomization until the end radiotherapy, up to 3 months.
the Overall Quality of Life (QOL)
The overall quality of life was assessed by EORTC QLQ-C30 questionnaire. QLQ-C30 scores were valued weekly during radiotherapy and post radiotherapy.The worst score of patients was recorded. The QLQ-C30 was scored from 0 to 100. Higher scores for function indicated a better QOL whereas the symptoms indicated a worsening QOL.
Measured: From date of randomization until the end radiotherapy, up to 3 months.
Quality of Life Specific to Head and Neck Cancers
Quality of life specific to head and neck cancers was assessed by EORTC QLQ-H\&N35 questionnaire. QLQ-H\&N35 scores were valued weekly during radiotherapy and post radiotherapy. The highest score of patients was recorded. The QLQ-H\&N35 was scored from 0 to 100. Higher scores indicated a worsening QOL.
Measured: From date of randomization until the end radiotherapy, up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Jan 2017
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Kanglaite injection + Radiotherapy ± Chemotherapy
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi-Ping Liu, MD, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101514
- Sponsor's protocol ID
- 201708
- Status last verified
- Feb 2021
- First submitted
- 20 Mar 2017
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have no other clinical trial about cancer of head and neck
Publications
Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.
PubMed 12742264Redding SW. Cancer therapy-related oral mucositis. J Dent Educ. 2005 Aug;69(8):919-29.
PubMed 16081575Silverman S Jr. Diagnosis and management of oral mucositis. J Support Oncol. 2007 Feb;5(2 Suppl 1):13-21.
PubMed 17366929Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.
PubMed 18360600Rodriguez-Caballero A, Torres-Lagares D, Robles-Garcia M, Pachon-Ibanez J, Gonzalez-Padilla D, Gutierrez-Perez JL. Cancer treatment-induced oral mucositis: a critical review. Int J Oral Maxillofac Surg. 2012 Feb;41(2):225-38. doi: 10.1016/j.ijom.2011.10.011. Epub 2011 Nov 8.
PubMed 22071451Walsh L, Gillham C, Dunne M, Fraser I, Hollywood D, Armstrong J, Thirion P. Toxicity of cetuximab versus cisplatin concurrent with radiotherapy in locally advanced head and neck squamous cell cancer (LAHNSCC). Radiother Oncol. 2011 Jan;98(1):38-41. doi: 10.1016/j.radonc.2010.11.009. Epub 2010 Dec 13.
PubMed 21159400Chen Y, Liu MZ, Liang SB, Zong JF, Mao YP, Tang LL, Guo Y, Lin AH, Zeng XF, Ma J. Preliminary results of a prospective randomized trial comparing concurrent chemoradiotherapy plus adjuvant chemotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma in endemic regions of china. Int J Radiat Oncol Biol Phys. 2008 Aug 1;71(5):1356-64. doi: 10.1016/j.ijrobp.2007.12.028. Epub 2008 May 9.
PubMed 18472356
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study
- ClinicalTrials.gov ID
- NCT03101514
- Acronym / sponsor ID
- 201708
- Conditions
- Head and Neck Cancer, Radiotherapy
- Keywords
- head and neck, tumor, radiotherapy, mucositis, toxicity, Kanglaite injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 89%-100% patients with head and neck malignant tumors have radiation mucositis during their radiotherapy. Until now, there is no effective method to prevent mucositis. Steroid hormone, pain-relief, anti-inflammatory and other symptom-relief treatments usually are used after the emergence of mucositis. Coixenol triglyceride is an ester extract of Coix Seed. Its trade name is Kanglaite Injection, which has been approved in China and Russia. Kanglaite has anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite could also improve the quality of life of patients and mitigate the condition of the cachexia. In china, two studies evaluating treatment of Kanglaite to nasopharyngeal cancer, found that Kanglaite can reduce radiotherapy mucositis. So far, Kanglaite on the prevention and treatment of radiation mucositis of the head and neck malignant tumor is still lack of strong clinical trial evidence. This is a phase II, single center, one arm study with subject to evaluate the acute radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of head and neck cancer.
Detailed description
3-4 grade radiation mucositis account for 34%-56% in all head and neck patients treated by radiotherapy and >50% in patients treated by radiotherapy concurrent with chemotherapy. 3-4 grade radiation mucositis have obvious symptoms, presenting with fusion ulcers, ulcers bleeding or obvious pain need analgesic drugs. At this time, the patients can not eat or can only intake fluid diet, which led to weight loss, malnutrition, quality of life declined and a series of problems.
Kanglaite has anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite can reduce radiotherapy mucositis of nasopharyngeal cancer had been found initially in Chinese. Kanglaite on the prevention and treatment of radiation mucositis of the head and neck malignant tumor is still lack of strong clinical trial evidence. This is a phase II, single center, one arm study with subject to evaluation the acute radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of head and neck malignant tumors.
Kanglaite 200ml is injected intravenous from the first day to the last day of radiotherapy. Chemotherapy with cisplatin or nedaplatin (both 80-100mg/m2, 21 day per cycle, 1-3 cycles) is used or not concurrent with radiotherapy. There is no order of Kanglaite injection and radiotherapy. Granulocyte colony stimulating factor and antibiotics have no prophylactic use, but can be used after the decline of white blood cells. Mucositis, nutritional status, and quality of life are evaluated before radiotherapy, every week of radiotherapy, 4 weeks after radiotherapy. Mucositis is verified by physical examination. Nutritional status is evaluated by patient-generated subjective global assessment (PG-SGA) scale. Quality of life is evaluated by EORTC QLQ-C30 and QLQ-H\&N35 questionnaire.
This is a one arm study, sample size calculation based on the incidence of 3-4 degree mucositis. The incidence of 3-4 degree mucositis is about >50% according to literatures of head and neck squamous cell carcinoma intensity modulated radiation therapy concurrent with chemotherapy. So we assume that Kanglaite can reduce 3-4 degree mucositis from 50% to 30%. The sample size required 44 cases according to the superiority test, bilateral Class I error α = 0.05, class II error β = 0.2. Total 49 cases are need, assuming the off rate of 10%.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Kanglaite injection + Radiotherapy ± Chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Kanglaite group | Experimental | Drug: Kanglaite, Drug: chemotherapyKanglaite 200ml is injected once a day from Monday to Friday during radiotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-80 years old, expected survival period ≥ 12 months
- Karnofsky score ≥80 points
- Pathological confirmed head and neck malignant tumors (oral, oropharynx, hypopharynx, throat, nasopharynx, nasal paranasal sinus or other), radical radiotherapy (± chemotherapy) or postoperative radiotherapy (± chemotherapy), radiotherapy dose 60 -70Gy
- with or without induction chemotherapy (induced chemotherapy ≤ 3 cycles);
- Meet the following laboratory diagnostic indicators:
Key exclusion criteria (9 listed)
- Distant metastases
- Allergy to Kanglaite
- Head and neck had previously received radiation therapy
- Pregnancy or lactation patients
- Targeted drug therapy during radiotherapy
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 |
|---|---|---|
| KanglaiteAlso: Kanglaite injectionKanglaite injection 200ml is injected intravenous from the first day to the last day of radiotherapy. | Drug | Kanglaite group |
| chemotherapyAlso: Concurrent chemotherapyCisplatin 80-100mg/m2 was used every 3 weeks during radiotherapy. | Drug | Kanglaite group |
Primary outcome
the Incidence Rate of Severe Radiation Mucositis
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
The grade of radiation mucositis was assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
5 secondary outcomes
the Incidence Rate of Non-Hematologic Toxicity Side Events
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
the Incidence Rate of Hematologic Toxicity Side Events
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
the Nutritional Status
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
the Overall Quality of Life (QOL)
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
Quality of Life Specific to Head and Neck Cancers
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12742264Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.
- Background: PubMed 16081575Redding SW. Cancer therapy-related oral mucositis. J Dent Educ. 2005 Aug;69(8):919-29.
- Background: PubMed 17366929Silverman S Jr. Diagnosis and management of oral mucositis. J Support Oncol. 2007 Feb;5(2 Suppl 1):13-21.
- Background: PubMed 18360600Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.
- Background: PubMed 22071451Rodriguez-Caballero A, Torres-Lagares D, Robles-Garcia M, Pachon-Ibanez J, Gonzalez-Padilla D, Gutierrez-Perez JL. Cancer treatment-induced oral mucositis: a critical review. Int J Oral Maxillofac Surg. 2012 Feb;41(2):225-38. doi: 10.1016/j.ijom.2011.10.011. Epub 2011 Nov 8.
- Background: PubMed 21159400Walsh L, Gillham C, Dunne M, Fraser I, Hollywood D, Armstrong J, Thirion P. Toxicity of cetuximab versus cisplatin concurrent with radiotherapy in locally advanced head and neck squamous cell cancer (LAHNSCC). Radiother Oncol. 2011 Jan;98(1):38-41. doi: 10.1016/j.radonc.2010.11.009. Epub 2010 Dec 13.
- Background: PubMed 18472356Chen Y, Liu MZ, Liang SB, Zong JF, Mao YP, Tang LL, Guo Y, Lin AH, Zeng XF, Ma J. Preliminary results of a prospective randomized trial comparing concurrent chemoradiotherapy plus adjuvant chemotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma in endemic regions of china. Int J Radiat Oncol Biol Phys. 2008 Aug 1;71(5):1356-64. doi: 10.1016/j.ijrobp.2007.12.028. Epub 2008 May 9.
- Individual participant dataSharing planned: No. The investigators have no other clinical trial about cancer of head and neck
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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.
Zhi-Ping Liu, MD principal investigator
First Affiliated Hospital of Harbin Medical University
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 Kanglaite and chemotherapy in people with Head and Neck Cancer and Radiotherapy, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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 7 inclusion and 9 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 23 Jun 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 China. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
the Incidence Rate of Severe Radiation Mucositis (time frame: From date of randomization until the end radiotherapy, up to 3 months.). 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 NCT03101514, which also lists 7 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 23 Jun 2021.