Breast CancerNCT00910884
Plant Extracted Natural Compounds Impact on Stage IV Breast Cancer Survival Time and Remission.
An observational study of Breast Cancer, run by Brabant Research at 1 site in United States.
Trial summary
RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- laboratory biomarker analysis and therapeutic dietary intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2020to Sep 2021
- Phase
- Observational
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer not limited to "in-remission only." Any Stage of cancer; preference in population to Stage IV. Inclusions: Breast Cancer, any stage. In remission or not. Uterine Cancer, any stage. In remission or not. Ovarian Cancer, any stage. In remission or not. Hormonal Cancers, cell division driven by hormones. In remission or not. Skin Cancers, any stage. In remission or not. Exclusions: None noted at this time. Exclusions may be modified upon presentation. Look for updates.
DISEASE CHARACTERISTICS:
- Diagnosis of prostate, breast, or uterine cancer
- Early or late stage disease
- Currently waiting to initiate conventional therapy or radiotherapy OR receiving concurrent conventional chemotherapy or radiation therapy
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior or concurrent chemotherapy or hormonal therapy for cancer allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Brabant Research, Incorporated
Spokane Valley, Washington, 99216
Richard E. Lasker, PhD, 509-340-9902, rel@brabantresearch.com
About this study
Official title: Stage IV Breast Cancer Gene Expression Control Using Micro-Trace and Plant Extracted Natural G.R.A.S. (Generally Accepted As Safe), Compounds in Adjunct Therapy Alongside Conventional Cancer Protocols
RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers.
PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using natural plant extracted compounds, G.R.A.S. (Generally Accepted As Safe), compounds, the reproduction, growth progress and metastasis of Stage IV Breast Cancer cells. The therapy position is adjunct to conventional therapies and in "one-off" trials have been excitingly effective for long-term survival. Novel use of bioactive GRAS compounds to augment and enhance conventional cancer therapies and as stand-alone parallel therapies.
Read the detailed description
OBJECTIVES:
To utilize multiple naturally-occurring bioalkaloids, bioactive "compounds of interest" from multiple sources, to influence prostate, breast, and uterine cancer pathways in cancer patients and cancer patients in remission. Other cancer types may be applicable.
To utilize specific naturally-occurring bioalkaloids and bioactive "compounds of interest" to suppress cancer proliferation-stimulation/growth activities induced by normal cancer metabolism including environmental estrogen impact, estrogen-mimicking compounds, estrogen-influencing and testosterone-type compounds.
To utilize DNA interaction with proliferating cancer cells via intercalation, which has a binding impact activity that then impairs DNA polymerase furthering DNA strand breakage and complete apoptosis. In addition, these bioactive compounds through intercalation, prevent cancer-cell DNA strand breakage from re-connection and repair, (limitlessness) while depleting nuclear topoisomerase, the enzyme also targeted by a number of conventional chemotherapy routes. Finally; a number of the bioalkaloids binds to cancer telomeres capping them at specific number or reducing them to "one and done."
Natural GRAS compounds, in previous studies that background this research, reduced secondary bonding of TMPRSS2-ERG fusing affecting testosterone \& estrogen hormone influence in cell proliferation. Variant mRNAs of, for example, the TMPRSS2-ERG fusing pathway were affected whereas normalized mRNAs in all other cells were not, a mechanism and chemistry not readily understood.
To utilize natural extracted plant compounds as a means to influence DIABLO (direct inhibitor of apoptosis binding protein with low isoelectric point) by downregulating over 350 genes which influence extracellular matrix (ECM) receptor interaction, and complement coagulation cascades were upregulated.
To utilize applications of, or ingestion of, specifically grown plant species/subspecies, extract the "compounds of action" or "compounds of activity" but maintaining an "entourage-affect by protecting "multi-compound complex arrangement chemistry" to maintain normal metabolic functionality of the compounds of interest..
BACKGROUND DATA:
Pharmaceutica has, since the turn of the 1800s to the 1900s, tried to find, extract and/or synthesize plant \& biological compounds that have the highest activity in a given medical treatment regime. In many cases the object was to get to the heart of the active compound, discarding non-active compounds,and, in other cases for various reasons including stockholder satisfaction, to be able to patent the synthesis chemistry and prevent duplication by competitors.
The one point of this important to this work is that the natural multi-compounds were the "compounds of action" for centuries and in most cases, in the natural form they were utilized in pre-20th century medicine, while the action of control was usually much slower, the side affects were non-existent.
Recent research (sic) now places a more important role of the "multi-compound" and the "entourage-effect' they have as cancer cells are quick to evolve, like viruses, and where the pharmaceutica "single compound of action" approach works well when ALL the cancer cells are eliminated, does not work well when surviving cells evolve to create resistance...a common outcome to most advanced stage cancers.
The "entourage-effect" using the "multi-compound" natural extracted compounds appears to negate the evolution/resistance response of cancerous cells by having multiple "chemistries of action" involved the cancer-control process which then hides/disguises the metabolic pathway of control from the surviving cancer cells.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive oral natural supplements comprising indole-3-carbinol, perillyl alcohol, glucuronic acid, and flavonoids daily for 12 months. Patients also consume whole foods comprising indole-3-carbinol and a diet that eliminates exogenous growth hormones.
Arm II: Patients do not receive natural supplements or consume whole foods or a special diet.
Levels of compounds of interest are measured by inductively-coupled plasma mass spectrometry, high performance liquid chromatography, gas chromatography, and matrix-assisted laser desorption/ionization time of flight mass spectrometry.
After completion of study therapy, patients are followed periodically for 6 months and monitored for a second 6 months period.
- Krimsky S (December 2001). "An epistemological inquiry into the endocrine disruptor thesis". Ann. N. Y. Acad. Sci. 948 (1): 130-42. doi:10.1111/j.1749-6632.2001.tb03994.x. PMID 11795392.
- Marinucci L, Bodo M, Balloni S, Locci P, Baroni T. "Sub-Toxic Nicotine Concentrations Affect Extracellular Matrix and Growth Factor Signaling Gene Expressions in Human Osteoblasts." J Cell Physiol. 2014 Apr 29. doi: 10.1002/jcp.24661. PMID: 24777817
- Camargo IC, Leite GA, Pinto T, Ribeiro-Paes JT. "Histopathologycal findings in the ovaries and uterus of albino female rats promoted by co-administration of synthetic steroids and nicotine." Exp Toxicol Pathol. 2014 Jul;66(4):195-202. doi: 10.1016/j.etp.2014.01.005. Epub 2014 Feb 18. PMID: 24556002
- Raval AP. "Nicotine addiction causes unique detrimental effects on women's brains." J Addict Dis. 2011 Apr;30(2):149-58. doi: 10.1080/10550887.2011.554782. Review. PMID: 21491296
- Holloway AC, Salomon A, Soares MJ, Garnier V, Raha S, Sergent F, Nicholson CJ, Feige JJ, Benharouga M, Alfaidy N. "Characterization of the adverse effects of nicotine on placental development: in vivo and in vitro studies." Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E443-56. doi: 10.1152/ajpendo.00478.2013. Epub 2013 Dec 24. PMID: 24368670
- Bavarva JH, Tae H, Settlage RE, Garner HR. "Characterizing the Genetic Basis for Nicotine Induced Cancer Development: A Transcriptome Sequencing Study." PLoS One. 2013 Jun 18;8(6):e67252. Print 2013. PMID: 23825647
- Hayes, Tyrone B.; Anderson, Lloyd L.; Beasley, Val R.; de Solla, Shane R.; Iguchi, Taisen; et al. (2011). "Demasculinization and feminization of male gonads by atrazine: Consistent effects across vertebrate classes". The Journal of Steroid Biochemistry and Molecular Biology 127 (1-2): 64-73. doi:10.1016/j.jsbmb.2011.03.015. PMID 21419222
- Atrazine: Chemical Summary. Toxicity and Exposure Assessment for Children's Health (Report). U.S. Environmental Protection Agency. 4/24/2007
- Mizota, K.; Ueda, H. (2006). "Endocrine Disrupting Chemical Atrazine Causes Degranulation through Gq/11 Protein-Coupled Neurosteroid Receptor in Mast Cells". Toxicological Sciences 90 (2): 362-8. doi:10.1093/toxsci/kfj087. PMID 16381660
- Thomas, Christoforos; Strom A.; Lindberg K.; Gustafsson J. (22 June 2010). "Estrogen receptor beta decreases survival of p53-defective cancer cells after DNA damage by impairing G2/M checkpoint signaling". Breast Cancer Research and Treatment 127 (2): 417-427. doi:10.1007/s10549-010-1011-z. PMID 20623183
- Conditions
- Breast Cancer
- Being tested
- laboratory biomarker analysis, therapeutic dietary intervention
- Keywords
- stage I breast cancer, stage II breast cancer, stage III breast cancer, stage IV breast cancer, hormonal cancers, skin cancers
- Medical subject headings
- Breast Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
No supplements are given
therapeutic dietary interventionProcedure or surgery
Given orally daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Patients receive oral GRAS supplements daily for 12 months or as possible within the patient's parameters. Receives: Other: laboratory biomarker analysis; Procedure: therapeutic dietary intervention | |
| Arm II | Patients do not receive supplements. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilize GRAS plant extracted compounds for suppression of cancer-cell replication.
Using adjunct therapy to augment and increase efficacy of conventional cancer treatments
Measured: 12 months
Suppression of cancer genetic pathways to reproduction.
suppress cancer cell proliferation
Measured: 6 months
Reduction of secondary bonding of TMPRSS2-ERG fusing using, among other modes of action, DPPH radical-scavenging activity
Monitor levels
Measured: 6 months
Monitor normal metabolic function while measuring cancer-marker levels.
metabolic function testing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startSep 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brabant Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Richard Lasker, Brabant Research
- Investigators
- Richard E. Lasker, PhD, Principal investigator, Brabant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910884
- Sponsor's protocol ID
- CDR0000643461
- Other IDs
- BRABANT-00005271
- Status last verified
- Jan 2020
- First submitted
- 29 May 2009
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage IV Breast Cancer Gene Expression Control Using Micro-Trace and Plant Extracted Natural G.R.A.S. (Generally Accepted As Safe), Compounds in Adjunct Therapy Alongside Conventional Cancer Protocols
- ClinicalTrials.gov ID
- NCT00910884
- Acronym / sponsor ID
- CDR0000643461
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage III breast cancer, stage IV breast cancer, hormonal cancers, skin cancers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brabant ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 1 Jun 2009 (estimated)
- 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.
RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers.
PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using natural plant extracted compounds, G.R.A.S. (Generally Accepted As Safe), compounds, the reproduction, growth progress and metastasis of Stage IV Breast Cancer cells. The therapy position is adjunct to conventional therapies and in "one-off" trials have been excitingly effective for long-term survival. Novel use of bioactive GRAS compounds to augment and enhance conventional cancer therapies and as stand-alone parallel therapies.
Detailed description
OBJECTIVES:
To utilize multiple naturally-occurring bioalkaloids, bioactive "compounds of interest" from multiple sources, to influence prostate, breast, and uterine cancer pathways in cancer patients and cancer patients in remission. Other cancer types may be applicable.
To utilize specific naturally-occurring bioalkaloids and bioactive "compounds of interest" to suppress cancer proliferation-stimulation/growth activities induced by normal cancer metabolism including environmental estrogen impact, estrogen-mimicking compounds, estrogen-influencing and testosterone-type compounds.
To utilize DNA interaction with proliferating cancer cells via intercalation, which has a binding impact activity that then impairs DNA polymerase furthering DNA strand breakage and complete apoptosis. In addition, these bioactive compounds through intercalation, prevent cancer-cell DNA strand breakage from re-connection and repair, (limitlessness) while depleting nuclear topoisomerase, the enzyme also targeted by a number of conventional chemotherapy routes. Finally; a number of the bioalkaloids binds to cancer telomeres capping them at specific number or reducing them to "one and done."
Natural GRAS compounds, in previous studies that background this research, reduced secondary bonding of TMPRSS2-ERG fusing affecting testosterone \& estrogen hormone influence in cell proliferation. Variant mRNAs of, for example, the TMPRSS2-ERG fusing pathway were affected whereas normalized mRNAs in all other cells were not, a mechanism and chemistry not readily understood.
To utilize natural extracted plant compounds as a means to influence DIABLO (direct inhibitor of apoptosis binding protein with low isoelectric point) by downregulating over 350 genes which influence extracellular matrix (ECM) receptor interaction, and complement coagulation cascades were upregulated.
To utilize applications of, or ingestion of, specifically grown plant species/subspecies, extract the "compounds of action" or "compounds of activity" but maintaining an "entourage-affect by protecting "multi-compound complex arrangement chemistry" to maintain normal metabolic functionality of the compounds of interest..
BACKGROUND DATA:
Pharmaceutica has, since the turn of the 1800s to the 1900s, tried to find, extract and/or synthesize plant \& biological compounds that have the highest activity in a given medical treatment regime. In many cases the object was to get to the heart of the active compound, discarding non-active compounds,and, in other cases for various reasons including stockholder satisfaction, to be able to patent the synthesis chemistry and prevent duplication by competitors.
The one point of this important to this work is that the natural multi-compounds were the "compounds of action" for centuries and in most cases, in the natural form they were utilized in pre-20th century medicine, while the action of control was usually much slower, the side affects were non-existent.
Recent research (sic) now places a more important role of the "multi-compound" and the "entourage-effect' they have as cancer cells are quick to evolve, like viruses, and where the pharmaceutica "single compound of action" approach works well when ALL the cancer cells are eliminated, does not work well when surviving cells evolve to create resistance...a common outcome to most advanced stage cancers.
The "entourage-effect" using the "multi-compound" natural extracted compounds appears to negate the evolution/resistance response of cancerous cells by having multiple "chemistries of action" involved the cancer-control process which then hides/disguises the metabolic pathway of control from the surviving cancer cells.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive oral natural supplements comprising indole-3-carbinol, perillyl alcohol, glucuronic acid, and flavonoids daily for 12 months. Patients also consume whole foods comprising indole-3-carbinol and a diet that eliminates exogenous growth hormones.
Arm II: Patients do not receive natural supplements or consume whole foods or a special diet.
Levels of compounds of interest are measured by inductively-coupled plasma mass spectrometry, high performance liquid chromatography, gas chromatography, and matrix-assisted laser desorption/ionization time of flight mass spectrometry.
After completion of study therapy, patients are followed periodically for 6 months and monitored for a second 6 months period.
- Krimsky S (December 2001). "An epistemological inquiry into the endocrine disruptor thesis". Ann. N. Y. Acad. Sci. 948 (1): 130-42. doi:10.1111/j.1749-6632.2001.tb03994.x. PMID 11795392.
- Marinucci L, Bodo M, Balloni S, Locci P, Baroni T. "Sub-Toxic Nicotine Concentrations Affect Extracellular Matrix and Growth Factor Signaling Gene Expressions in Human Osteoblasts." J Cell Physiol. 2014 Apr 29. doi: 10.1002/jcp.24661. PMID: 24777817
- Camargo IC, Leite GA, Pinto T, Ribeiro-Paes JT. "Histopathologycal findings in the ovaries and uterus of albino female rats promoted by co-administration of synthetic steroids and nicotine." Exp Toxicol Pathol. 2014 Jul;66(4):195-202. doi: 10.1016/j.etp.2014.01.005. Epub 2014 Feb 18. PMID: 24556002
- Raval AP. "Nicotine addiction causes unique detrimental effects on women's brains." J Addict Dis. 2011 Apr;30(2):149-58. doi: 10.1080/10550887.2011.554782. Review. PMID: 21491296
- Holloway AC, Salomon A, Soares MJ, Garnier V, Raha S, Sergent F, Nicholson CJ, Feige JJ, Benharouga M, Alfaidy N. "Characterization of the adverse effects of nicotine on placental development: in vivo and in vitro studies." Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E443-56. doi: 10.1152/ajpendo.00478.2013. Epub 2013 Dec 24. PMID: 24368670
- Bavarva JH, Tae H, Settlage RE, Garner HR. "Characterizing the Genetic Basis for Nicotine Induced Cancer Development: A Transcriptome Sequencing Study." PLoS One. 2013 Jun 18;8(6):e67252. Print 2013. PMID: 23825647
- Hayes, Tyrone B.; Anderson, Lloyd L.; Beasley, Val R.; de Solla, Shane R.; Iguchi, Taisen; et al. (2011). "Demasculinization and feminization of male gonads by atrazine: Consistent effects across vertebrate classes". The Journal of Steroid Biochemistry and Molecular Biology 127 (1-2): 64-73. doi:10.1016/j.jsbmb.2011.03.015. PMID 21419222
- Atrazine: Chemical Summary. Toxicity and Exposure Assessment for Children's Health (Report). U.S. Environmental Protection Agency. 4/24/2007
- Mizota, K.; Ueda, H. (2006). "Endocrine Disrupting Chemical Atrazine Causes Degranulation through Gq/11 Protein-Coupled Neurosteroid Receptor in Mast Cells". Toxicological Sciences 90 (2): 362-8. doi:10.1093/toxsci/kfj087. PMID 16381660
- Thomas, Christoforos; Strom A.; Lindberg K.; Gustafsson J. (22 June 2010). "Estrogen receptor beta decreases survival of p53-defective cancer cells after DNA damage by impairing G2/M checkpoint signaling". Breast Cancer Research and Treatment 127 (2): 417-427. doi:10.1007/s10549-010-1011-z. PMID 20623183
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | – | Other: laboratory biomarker analysis, Procedure: therapeutic dietary interventionPatients receive oral GRAS supplements daily for 12 months or as possible within the patient's parameters. |
| Arm II | – | Other: laboratory biomarker analysisPatients do not receive supplements. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer not limited to "in-remission only." Any Stage of cancer; preference in population to Stage IV. Inclusions: Breast Cancer, any stage. In remission or not. Uterine Cancer, any stage. In remission or not. Ovarian Cancer, any stage. In remission or not. Hormonal Cancers, cell division driven by hormones. In remission or not. Skin Cancers, any stage. In remission or not. Exclusions: None noted at this time. Exclusions may be modified upon presentation. Look for updates.
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 |
|---|---|---|
| laboratory biomarker analysisNo supplements are given | Other | Arm I, Arm II |
| therapeutic dietary interventionGiven orally daily for 12 months | Procedure or surgery | Arm I |
Primary outcome
Utilize GRAS plant extracted compounds for suppression of cancer-cell replication.
Time frame: 12 months
Using adjunct therapy to augment and increase efficacy of conventional cancer treatments
Suppression of cancer genetic pathways to reproduction.
Time frame: 6 months
suppress cancer cell proliferation
Reduction of secondary bonding of TMPRSS2-ERG fusing using, among other modes of action, DPPH radical-scavenging activity
Time frame: 6 months
Monitor levels
Monitor normal metabolic function while measuring cancer-marker levels.
Time frame: 6 months
metabolic function testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Richard E. Lasker, PhD principal investigator
Brabant Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Brabant Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilize GRAS plant extracted compounds for suppression of cancer-cell replication. (time frame: 12 months). The study lists 4 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 Jan 2020.