Breast CancerNCT04843865
TCM as an Adjuvant Treatment in Breast Cancer Patients
A study testing Chinese Herbs in people with Breast Cancer and Musculoskeletal Pain, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial summary
Chinese herbs can alleviates the side effects caused by conventional treatment in breast cancer patients and affects the syndrome element differentiation by altering the specific set of proteomes at specific time point of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Musculoskeletal Pain
- What is being tested?
- Chinese Herbs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 22 Apr 2022to Dec 2024
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women as determined by cessation of menses for at least 1 year or FSH>20 mIU/mL
- Histology confirmed stage 2 to 3 hormone-receptor positive breast cancer patient
- Currently taking letrozole for at least 1 month
- Reported ongoing musculoskeletal pain or stiffness, which started or worsened after initiation of letrozole
- Had a baseline average pain score over the past week on the Brief Pain Inventory Short Form (BPI-SF) of ≥4 points on a scale of 0 to 10.
- Completed all indicated surgery, chemotherapy and radiation therapy
Show all 12Show fewer
- Agreed to take prescribed Chinese herbs
- No evidence of distant metastasis
- Follow-up for the duration of the study
- No acute disease in the past month
- Able to communicate to practitioner and interviewer
- Willing to give informed consent
Who cannot join
- Pregnant or nursing woman or woman of childbearing potential without effective method of birth control.
- Patients who default subsequent follow-up/ has irregular follow-up.
- Patients who directly involved in other study at the same time.
- History of non-compliance to medical regime and patients who are unwilling or unable to comply with the protocol.
- Bedridden and/ or cancer metastasis to bone/ lung.
- Concurrent infection requiring intravenous antibiotics
Show all 12Show fewer
- History of allergy to Chinese herbs
- Had previously received Chinese herbs for their AI-induced musculoskeletal symptoms
- Had received Chinese herbs within one month prior to study entry
- Current use of steroids or narcotics for pain relief within the past 2 weeks
- Subjects with acute onset of a chronic illness or with acute disease in the past month or had pre-existing chronic diseases
- Patients with concomitant severe illness or metastatic disease (poorly controlled hypertension, hypothyroidism, diabetes mellitus, liver diseases, osteoarthritis, rheumatoid arthritis, gout or neuropathic arthropathy, autoimmune or inflammatory joint disease, bone fracture, stroke)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Tung Shin Hospital
Bukit Bintang, Kuala Lumpur, 55100
King Keong Chung, 0122027322, chungkk@tungshin.com.my
Yang Mooi Lim
About this study
Official title: A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients
Chinese herbs can alleviates the side effects caused by conventional treatment in breast cancer patients and affects the syndrome element differentiation by altering the specific set of proteomes at specific time point of treatment.
Read the detailed description
The previous studies have reported that adjuvant Chinese herbs therapy can improve the survival of breast cancer patients by alleviating the side effects of conventional treatments. Protein expression determines the phenotype of a patient that contributes to the onset of side effects in breast cancer patients caused by conventional treatment. Chinese herbs treatment will alleviate the treatment-related side effects by altering the protein expression in the patients. Associating changes in protein levels with the onset of side effects caused by conventional treatments could be used to identify clinically relevant diagnostic biomarkers. In addition, a set of proteome that is being expressed at diseased state will exhibit the phenotype that is also correlated to the TCM syndrome differentiation. Hence, this study aims to determine the proteome profile for the syndrome differentiation of breast cancer patients treated with adjuvant Chinese herbs for musculoskeletal pain. A quasi-experimental study with purposive sampling will be conducted on 30 breast cancer patients recruited from Tung Shin hospital. All participants will be invited to complete a structured questionnaire to collect their demographic information, pain score, syndrome element differentiation, quality of life, stress, body constitution and other relevant information, including cancer type, cancer stage, and cancer treatment. The questionnaires will be self-administered either at the outpatient waiting room or in the ward of the study hospital. Blood of the patients will be collected for determination of protein expression, biochemical markers and cytokines. The study is an in-point analysis where 2 time-points of data collection and analysis will be carried out at baseline, and immediate post Chinese herbs treatment. Informed consent will be obtained before participant enrolment according to a clinical trial protocol. Statistical differences for protein expression, biochemical markers, cytokines and mean pain score before and after Chinese herbs treatment will be compared using the paired-sample t test.
- Conditions
- Breast Cancer, Musculoskeletal Pain
- Being tested
- Chinese Herbs
- Keywords
- Chinese herbs, Breast cancer, Aromatase inhibitor-associated musculoskeletal symptoms, Protein profiling, System biology, Syndrome element differentiation
- Medical subject headings
- Breast Neoplasms, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese HerbsDietary supplement
Chinese Herbs
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbs | Experimental | Participants received standardized Chinese Herbs treatment orally twice daily for 1 week. Receives: Dietary Supplement: Chinese Herbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the study (Adherence)
The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.
Measured: Immediate post 1 week of Chinese Herbs intervention
Secondary outcomes (13)
Feasibility of the study (Dropout rate)
The feasibility will be assessed by dropout rate of the patients.
Measured: Immediate post 1 week of Chinese Herbs intervention
Change in the pain score
The pain score of breast cancer patients will be assessed by Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a validated and reliable tool used to assess the severity or intensity of pain on scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores mean a worse outcome.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Syndrome element differentiation
Syndrome Element Differentiation rating scale will be used to determine the syndrome element differentiation of the patients. Syndrome Element Differentiation rating scale can quantify the syndrome elements of this patient based on the clinical manifestations. The quantitative output weight values of syndrome elements are acquired from clinical input data based on the severity and frequency of each sign and symptom. Based on the quantitative output value, the syndrome elements can then be categorized into four levels of health state or severity: normal (<70), mild (≥ 70 to <100), moderate (≥100 to <150), and severe (≥ 150).
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life)
The quality of life will be assessed by the WHO-BREF questionnaire in this study. The WHOQOL-BREF instrument comprises 26 items, measuring the following broad domains: physical health, psychological health, social relationships, and environment, with scores ranging from 0 to 100. The four domain scores denote an individual's perception of the quality of life in each domain. Domain scores are scaled in a positive direction in which higher scores denote a higher quality of life.
- the minimum and maximum values: 0, 100
- higher scores mean a better outcome.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in stress
The Depression Anxiety Stress Scales (DASS) is a self-report instrument designed to measure the negative emotional states of depression, anxiety and stress. A short version, the DASS 21 scale consists of a list of 21 symptoms with 7 item per scale, each of which is to be rated on a four-point scale of how much you had that symptom in the last week from 'never' to 'most of the time'. In this study, stress will be determined by stress domain of DASS-21 which consists of 7 items.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in body constitution assessed by Constitution in Chinese Medicine Questionnaire (CCMQ)
The body constitution will be determined by Constitution in Chinese Medicine Questionnaire (CCMQ). It has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness-heat, blood-stasis, Qi-depression, and special diathesis.
- the minimum and maximum values: 0, 100
- higher scores mean a worse outcome.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in protein expression
The serum proteome will be analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Liver Function Test
The liver function of the patients will be determined by measuring the alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in CEA (Carcino-Embryonic Antigen)
Change in CEA (Carcino-Embryonic Antigen) will be determined by laboratory examination.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in CRP (C-Reactive Protein)
Change in CRP (C-Reactive Protein) will be determined by laboratory examination.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Progesterone
Change in Progesterone will be determined by laboratory examination.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Estradiol
Change in Estradiol will be determined by laboratory examination.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Cytokine levels of serum
The cytokines in serum samples of breast cancer patients will be detected by the Quantibody array, multiplexed sandwich enzyme-linked immunosorbent assay (ELISA) based quantitative array platform (Genomax technology) for quantitative measurement of cytokines in human serum. The unit of measurement for the cytokines is the same.
Measured: Baseline and immediate post 1 week of Chinese Herbs intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start22 Apr 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi-experimental design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Mooi Lim, Universiti Tunku Abdul Rahman
- Investigators
- Yang Mooi Lim, Principal investigator, Universiti Tunku Abdul Rahman (UTAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843865
- Sponsor's protocol ID
- UTAR- 8068/000
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2021
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nie J, Zhao C, Deng LI, Chen J, Yu B, Wu X, Pang P, Chen X. Efficacy of traditional Chinese medicine in treating cancer. Biomed Rep. 2016 Jan;4(1):3-14. doi: 10.3892/br.2015.537. Epub 2015 Nov 5.
PubMed 26870326Sanchez-Vidana DI, Rajwani R, Wong MS. The Use of Omic Technologies Applied to Traditional Chinese Medicine Research. Evid Based Complement Alternat Med. 2017;2017:6359730. doi: 10.1155/2017/6359730. Epub 2017 Jan 31.
PubMed 28250795Wang XS, Mendoza TR, Gao SZ, Cleeland CS. The Chinese version of the Brief Pain Inventory (BPI-C): its development and use in a study of cancer pain. Pain. 1996 Oct;67(2-3):407-16. doi: 10.1016/0304-3959(96)03147-8.
PubMed 8951936Yan E, Song J, Liu C, Hong W. A research on syndrome element differentiation based on phenomenology and mathematical method. Chin Med. 2017 Jul 10;12:19. doi: 10.1186/s13020-017-0141-1. eCollection 2017.
PubMed 28702077Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53.
PubMed 22952508Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Wong W, Lam CL, Wong VT, Yang ZM, Ziea ET, Kwan AK. Validation of the constitution in chinese medicine questionnaire: does the traditional chinese medicine concept of body constitution exist? Evid Based Complement Alternat Med. 2013;2013:481491. doi: 10.1155/2013/481491. Epub 2013 Apr 24.
PubMed 23710222Karpievitch YV, Polpitiya AD, Anderson GA, Smith RD, Dabney AR. Liquid Chromatography Mass Spectrometry-Based Proteomics: Biological and Technological Aspects. Ann Appl Stat. 2010;4(4):1797-1823. doi: 10.1214/10-AOAS341.
PubMed 21593992
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04843865
- Acronym / sponsor ID
- UTAR- 8068/000
- Conditions
- Breast Cancer, Musculoskeletal Pain
- Keywords
- Chinese herbs, Breast cancer, Aromatase inhibitor-associated musculoskeletal symptoms, Protein profiling, System biology, Syndrome element differentiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chinese herbs can alleviates the side effects caused by conventional treatment in breast cancer patients and affects the syndrome element differentiation by altering the specific set of proteomes at specific time point of treatment.
Detailed description
The previous studies have reported that adjuvant Chinese herbs therapy can improve the survival of breast cancer patients by alleviating the side effects of conventional treatments. Protein expression determines the phenotype of a patient that contributes to the onset of side effects in breast cancer patients caused by conventional treatment. Chinese herbs treatment will alleviate the treatment-related side effects by altering the protein expression in the patients. Associating changes in protein levels with the onset of side effects caused by conventional treatments could be used to identify clinically relevant diagnostic biomarkers. In addition, a set of proteome that is being expressed at diseased state will exhibit the phenotype that is also correlated to the TCM syndrome differentiation. Hence, this study aims to determine the proteome profile for the syndrome differentiation of breast cancer patients treated with adjuvant Chinese herbs for musculoskeletal pain. A quasi-experimental study with purposive sampling will be conducted on 30 breast cancer patients recruited from Tung Shin hospital. All participants will be invited to complete a structured questionnaire to collect their demographic information, pain score, syndrome element differentiation, quality of life, stress, body constitution and other relevant information, including cancer type, cancer stage, and cancer treatment. The questionnaires will be self-administered either at the outpatient waiting room or in the ward of the study hospital. Blood of the patients will be collected for determination of protein expression, biochemical markers and cytokines. The study is an in-point analysis where 2 time-points of data collection and analysis will be carried out at baseline, and immediate post Chinese herbs treatment. Informed consent will be obtained before participant enrolment according to a clinical trial protocol. Statistical differences for protein expression, biochemical markers, cytokines and mean pain score before and after Chinese herbs treatment will be compared using the paired-sample t test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| Chinese Herbs | Experimental | Dietary Supplement: Chinese HerbsParticipants received standardized Chinese Herbs treatment orally twice daily for 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Postmenopausal women as determined by cessation of menses for at least 1 year or FSH>20 mIU/mL
- Histology confirmed stage 2 to 3 hormone-receptor positive breast cancer patient
- Currently taking letrozole for at least 1 month
- Reported ongoing musculoskeletal pain or stiffness, which started or worsened after initiation of letrozole
- Had a baseline average pain score over the past week on the Brief Pain Inventory Short Form (BPI-SF) of ≥4 points on a scale of 0 to 10.
Key exclusion criteria (12 listed)
- Pregnant or nursing woman or woman of childbearing potential without effective method of birth control.
- Patients who default subsequent follow-up/ has irregular follow-up.
- Patients who directly involved in other study at the same time.
- History of non-compliance to medical regime and patients who are unwilling or unable to comply with the protocol.
- Bedridden and/ or cancer metastasis to bone/ lung.
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 |
|---|---|---|
| Chinese HerbsChinese Herbs | Dietary supplement | Chinese Herbs |
Primary outcome
Feasibility of the study (Adherence)
Time frame: Immediate post 1 week of Chinese Herbs intervention
The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.
13 secondary outcomes
Feasibility of the study (Dropout rate)
Time frame: Immediate post 1 week of Chinese Herbs intervention
Change in the pain score
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Syndrome element differentiation
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life)
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in stress
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in body constitution assessed by Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in protein expression
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Liver Function Test
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in CEA (Carcino-Embryonic Antigen)
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in CRP (C-Reactive Protein)
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Progesterone
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Estradiol
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Cytokine levels of serum
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
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 31 Dec 2024.
- Background: PubMed 26870326Nie J, Zhao C, Deng LI, Chen J, Yu B, Wu X, Pang P, Chen X. Efficacy of traditional Chinese medicine in treating cancer. Biomed Rep. 2016 Jan;4(1):3-14. doi: 10.3892/br.2015.537. Epub 2015 Nov 5.
- Background: PubMed 28250795Sanchez-Vidana DI, Rajwani R, Wong MS. The Use of Omic Technologies Applied to Traditional Chinese Medicine Research. Evid Based Complement Alternat Med. 2017;2017:6359730. doi: 10.1155/2017/6359730. Epub 2017 Jan 31.
- Background: PubMed 8951936Wang XS, Mendoza TR, Gao SZ, Cleeland CS. The Chinese version of the Brief Pain Inventory (BPI-C): its development and use in a study of cancer pain. Pain. 1996 Oct;67(2-3):407-16. doi: 10.1016/0304-3959(96)03147-8.
- Background: PubMed 28702077Yan E, Song J, Liu C, Hong W. A research on syndrome element differentiation based on phenomenology and mathematical method. Chin Med. 2017 Jul 10;12:19. doi: 10.1186/s13020-017-0141-1. eCollection 2017.
- Background: PubMed 22952508Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 23710222Wong W, Lam CL, Wong VT, Yang ZM, Ziea ET, Kwan AK. Validation of the constitution in chinese medicine questionnaire: does the traditional chinese medicine concept of body constitution exist? Evid Based Complement Alternat Med. 2013;2013:481491. doi: 10.1155/2013/481491. Epub 2013 Apr 24.
- Background: PubMed 21593992Karpievitch YV, Polpitiya AD, Anderson GA, Smith RD, Dabney AR. Liquid Chromatography Mass Spectrometry-Based Proteomics: Biological and Technological Aspects. Ann Appl Stat. 2010;4(4):1797-1823. doi: 10.1214/10-AOAS341.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Mooi Lim principal investigator
Universiti Tunku Abdul Rahman (UTAR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Herbs in people with Breast Cancer and Musculoskeletal Pain, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 31 Dec 2024. 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 Malaysia. 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?
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 Chin Long Poo (0178853596, athrunjoe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study (Adherence) (time frame: Immediate post 1 week of Chinese Herbs intervention). 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 NCT04843865, which also lists 8 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 31 Dec 2024.