Breast CancerPhase 2DHA-WINNCT03831178
Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting
A Phase 2 study testing Docosahexaenoic acid (DHA) in people with Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Docosahexaenoic acid (DHA) is an omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA). N-3 LCPUFA are essential fatty acids in the diet. The majority of n-3 LCPUFA in the diet is alpha-linolenic acid (ALA). While DHA can be synthesized from ALA and other n-3 LCPUFA in the body, endogenous synthesis is low. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docosahexaenoic acid (DHA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2019to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with invasive (clinical stage I, II and III) breast cancer, for whom neoadjuvant systemic therapy with chemotherapy is recommended prior to surgery.
- ECOG Performance status of 0 or 1.
- Hematology and Biochemistry assessments (CBC and differential, PTT, PT/INR, AST, Alk Phos, Bilirubin, and Creatinine) within normal range unless determined not clinically significant by the qualified investigator.
- Ability to take oral medications.
- Adequate tissue specimen for diagnosis, biomarkers, and endpoint Ki67 assays.
Who cannot join
- Patients undergoing surgery prior to chemotherapy.
- Current or previous (within 2 months) daily use (>1 day/week) use of omega-3, fish oil, or other supplements or functional foods containing docosahexaenoic acid (at daily doses > 200 mg).
- Known allergy to soy or corn.
- Continued intake of supplements containing Vitamin C, Vitamin E or β-carotene exceeding the DRI, or other anti-oxidant supplements.
- Symptomatic but untreated cholelithiasis.
- History of deep venous thrombosis, active thrombophlebitis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension, known inherited hypercoagulable disorder.
Show all 10Show fewer
- Diagnosis of any other malignancy within the previous year except for adequately treated basal cell or squamous cell skin cancer.
- Medically documented history of a psychiatric disorder that would preclude consent
- Partial or complete loss of vision or diplopia, from ophthalmic vascular disease.
- Hypersensitivity to DHA or to any ingredient in the formulation or component of the container.
Trial locations and contacts
1 site in 1 country.
About this study
Docosahexaenoic acid (DHA) is an omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA). N-3 LCPUFA are essential fatty acids in the diet. The majority of n-3 LCPUFA in the diet is alpha-linolenic acid (ALA). While DHA can be synthesized from ALA and other n-3 LCPUFA in the body, endogenous synthesis is low. Consequently, the only way to significantly increase levels of DHA in tissues is by directly consuming this fatty acid. Common sources of DHA are fatty fish, fish oil and omega-3 supplements and fortified foods.
DHA is readily incorporated into membrane phospholipids and induces changes in the properties of the cell membrane including altered fluidity; permeability and membrane transport as well as activity of membrane bound receptors and enzymes.
Read more
It is well established that changes in membrane DHA has multiple effects in the body, including modulation of neurological, immune, and cardiovascular functions. In breast cancer, DHA increases sensitivity of breast cancer cells to different chemotherapeutic agents, and in animal models of breast cancer, dietary DHA decreases tumour growth. The investigator's preclinical studies demonstrate that DHA increases efficacy of both doxorubicin and docetaxel, two agents commonly used in the adjuvant setting for breast cancer treatment. Furthermore, DHA mitigates chemotherapy induced weight loss in mice, and reduces paclitaxel toxicities in breast cancer patients, strongly indicating that DHA protects against toxicity in normal tissues. Directly relevant to this study, increased DHA in breast adipose tissue correlates with improved response to chemotherapy, and increased dietary intake of n-3 LCPUFA, including DHA, results in increased DHA incorporation in breast adipose tissue. Lastly, in advanced metastatic breast cancer, DHA supplementation correlated with improved outcomes in a subset of patients. Consequently, the Investigators hypothesize that the therapeutic index (efficacy: toxicity ratio) will be improved with the addition of DHA. In this clinical trial, the Investigators will explore the benefit of DHA supplementation in combination with neoadjuvant chemotherapy in patients with early breast cancer.
RESEARCH QUESTION \& OBJECTIVES: The Investigators propose to evaluate incorporation of DHA in women with breast cancer in treatment naïve patients in combination with chemotherapy, and assess potential benefit of DHA supplementation in breast cancer patients, using change in Ki67 labeling index (marker of proliferation) as a marker of efficacy. This study will further investigate the relationship between DHA in plasma phospholipids (as a potential biomarker of tumour incorporation) and effect on systemic immune function.
METHODS: Patients directed to receive chemotherapy will receive capsules, each containing a minimum of 400 mg of DHA in the form of DHA enriched triglyceride oil or placebo (corn/soy oil blend) to be taken orally (11 capsules/day, throughout day as preferred by participant) for a total of 5 g DHA or placebo, for 12-18 weeks (84-126 days) beginning at the start of the first cycle of chemotherapy, and continued throughout 4-6 cycles of chemotherapy (3 weeks/ cycle). DHA will be discontinued 21 days after the last administration of cytotoxic chemotherapy. Tumour biopsies at baseline and post surgical removal will be assessed for Ki67 status as well as for markers of apoptosis and stem cell presence (by immunohistochemistry). Blood samples taken at baseline prior to each round of chemotherapy will be assessed for immune markers and plasma phospholipid content.
- Conditions
- Breast Cancer
- Being tested
- Docosahexaenoic acid (DHA), Placebo oral capsule
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid (DHA)Dietary supplement
Participants will take 11 capsules of DHA oil for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.
Placebo oral capsuleDrug
Participants will take 11 capsules of placebo (corn/soy oil blend) for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.
| Study group | Role | What they receive |
|---|---|---|
| DHA | Experimental | Participants will take 11 capsules per day containing DHA-enriched triglyceride oil (1 g capsules containing at least 400 mg DHA) for a total of 5 g DHA/day divided into three times daily with meals or as tolerated. Receives: Dietary Supplement: Docosahexaenoic acid (DHA) |
| Placebo | Placebo comparator | Participants will take 11 capsules per day containing corn/soy oil blend capsules divided into three times daily with meals or as tolerated. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Ki67 index from baseline to surgical excision.
Ki67 will be measured by image analysis at baseline biopsy and at experimental end (surgical excision).
Measured: Pre-intervention (on the baseline biopsy) and post- intervention (at the time of surgical excision).
Secondary outcomes (6)
Percent of DHA in plasma phospholipids between DHA and placebo arms.
Changes in level of DHA incorporation in plasma phospholipids will be assessed to identify the range of DHA incorporation in this patient population. Fatty acid composition of plasma phospholipids will be measured after lipid extraction, phospholipid separation on thin layer chromatography followed by methylation and separation identification by gas-liquid chromatography.
Measured: At day 0 and day 20 of cycles 1 to 6 of chemotherapy (each cycle is 20 days).
Change in immune function (e.g. ability to produce IL-2 after stimulation) following DHA supplementation in combination with chemotherapy.
Systemic immune function will be assessed on stored plasma by U-PLEX Biomarker Group 1 electrochemiluminescent multiplex assays (MesoScale Discovery).
Measured: Baseline (within 21 days before cycle 1 of chemotherapy) and at the end of chemotherapy cycle 3 (each cyle is 20 days)
Age of participants and other factors affecting DHA incorporation
If incorporation of DHA in plasma phospholipids is variable within the DHA treatment arm, possible factors that may influence incorporation (e.g. age of participants) will be explored between high and low incorporators.
Measured: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
Percent change on markers of apoptosis (e.g. caspase-3) following DHA or placebo supplementation.
Breast tissue from participants receiving DHA or placebo will be assessed for markers of apoptosis (e.g. caspase-3) by immunohistochemistry and calculated by image analysis.
Measured: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
Pathological complete response rate
Pathological complete response in resected breast tissue and all sampled axillary nodes will be assessed as absence of invasive cancer on haematoxylin and eosin evaluation as per standard of care.
Measured: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
Comparison of rate of chemotherapy associated grade 3 and 4 toxicities between treatment arms.
Rate of chemotherapy associated grade 3 and 4 toxicities, and chemotherapy- associated hospitalizations will be compared between DHA and placebo arms.
Measured: At day 20 of chemotherapy cycles 1 to 6 (each cycle is 20 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start28 Aug 2019
- Primary completion1 Dec 2024
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Responsible party
- Sponsor
- Investigators
- John Mackey, MD, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831178
- Sponsor's protocol ID
- IIT-0005
- Acronym
- DHA-WIN
- Status last verified
- Nov 2026
- First submitted
- 14 Jan 2019
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Cross Cancer Institute and the University of Alberta encourages and supports the responsible and ethical sharing of data from clinical trials. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov.
Publications
Newell M, Mackey JR, Bigras G, Alvarez-Camacho M, Goruk S, Ghosh S, Schmidt A, Miede D, Chisotti A, Postovit L, Baker K, Mazurak V, Courneya K, Berendt R, Dong WF, Wood G, Basi SK, Joy AA, King K, Meza-Junco J, Zhu X, Field C. Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial. BMJ Open. 2019 Sep 17;9(9):e030502. doi: 10.1136/bmjopen-2019-030502.
PubMed 31530611Douglas CM, Newell M, Goruk S, Courneya KS, Ghosh S, Joy AA, Munhoz J, Field CJ. Exploratory outcomes of the DHA WIN randomized controlled trial: Supplementing women with docosahexaenoic acid did not reduce the impact of neoadjuvant breast cancer chemotherapy on quality of life or exercise behaviour. PLoS One. 2025 May 2;20(5):e0322178. doi: 10.1371/journal.pone.0322178. eCollection 2025.
PubMed 40315249
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting
- ClinicalTrials.gov ID
- NCT03831178
- Acronym / sponsor ID
- DHA-WIN / IIT-0005
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Feb 2019 (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.
Docosahexaenoic acid (DHA) is an omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA). N-3 LCPUFA are essential fatty acids in the diet. The majority of n-3 LCPUFA in the diet is alpha-linolenic acid (ALA). While DHA can be synthesized from ALA and other n-3 LCPUFA in the body, endogenous synthesis is low. Consequently, the only way to significantly increase levels of DHA in tissues is by directly consuming this fatty acid. Common sources of DHA are fatty fish, fish oil and omega-3 supplements and fortified foods.
DHA is readily incorporated into membrane phospholipids and induces changes in the properties of the cell membrane including altered fluidity; permeability and membrane transport as well as activity of membrane bound receptors and enzymes.
It is well established that changes in membrane DHA has multiple effects in the body, including modulation of neurological, immune, and cardiovascular functions. In breast cancer, DHA increases sensitivity of breast cancer cells to different chemotherapeutic agents, and in animal models of breast cancer, dietary DHA decreases tumour growth. The investigator's preclinical studies demonstrate that DHA increases efficacy of both doxorubicin and docetaxel, two agents commonly used in the adjuvant setting for breast cancer treatment. Furthermore, DHA mitigates chemotherapy induced weight loss in mice, and reduces paclitaxel toxicities in breast cancer patients, strongly indicating that DHA protects against toxicity in normal tissues. Directly relevant to this study, increased DHA in breast adipose tissue correlates with improved response to chemotherapy, and increased dietary intake of n-3 LCPUFA, including DHA, results in increased DHA incorporation in breast adipose tissue. Lastly, in advanced metastatic breast cancer, DHA supplementation correlated with improved outcomes in a subset of patients. Consequently, the Investigators hypothesize that the therapeutic index (efficacy: toxicity ratio) will be improved with the addition of DHA. In this clinical trial, the Investigators will explore the benefit of DHA supplementation in combination with neoadjuvant chemotherapy in patients with early breast cancer.
RESEARCH QUESTION \& OBJECTIVES: The Investigators propose to evaluate incorporation of DHA in women with breast cancer in treatment naïve patients in combination with chemotherapy, and assess potential benefit of DHA supplementation in breast cancer patients, using change in Ki67 labeling index (marker of proliferation) as a marker of efficacy. This study will further investigate the relationship between DHA in plasma phospholipids (as a potential biomarker of tumour incorporation) and effect on systemic immune function.
METHODS: Patients directed to receive chemotherapy will receive capsules, each containing a minimum of 400 mg of DHA in the form of DHA enriched triglyceride oil or placebo (corn/soy oil blend) to be taken orally (11 capsules/day, throughout day as preferred by participant) for a total of 5 g DHA or placebo, for 12-18 weeks (84-126 days) beginning at the start of the first cycle of chemotherapy, and continued throughout 4-6 cycles of chemotherapy (3 weeks/ cycle). DHA will be discontinued 21 days after the last administration of cytotoxic chemotherapy. Tumour biopsies at baseline and post surgical removal will be assessed for Ki67 status as well as for markers of apoptosis and stem cell presence (by immunohistochemistry). Blood samples taken at baseline prior to each round of chemotherapy will be assessed for immune markers and plasma phospholipid content.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA | Experimental | Dietary Supplement: Docosahexaenoic acid (DHA)Participants will take 11 capsules per day containing DHA-enriched triglyceride oil (1 g capsules containing at least 400 mg DHA) for a total of 5 g DHA/day divided into three times daily with meals or as tolerated. |
| Placebo | Placebo comparator | Drug: Placebo oral capsuleParticipants will take 11 capsules per day containing corn/soy oil blend capsules divided into three times daily with meals or as tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with invasive (clinical stage I, II and III) breast cancer, for whom neoadjuvant systemic therapy with chemotherapy is recommended prior to surgery.
- ECOG Performance status of 0 or 1.
- Hematology and Biochemistry assessments (CBC and differential, PTT, PT/INR, AST, Alk Phos, Bilirubin, and Creatinine) within normal range unless determined not clinically significant by the qualified investigator.
- Ability to take oral medications.
- Adequate tissue specimen for diagnosis, biomarkers, and endpoint Ki67 assays.
Key exclusion criteria (10 listed)
- Patients undergoing surgery prior to chemotherapy.
- Current or previous (within 2 months) daily use (>1 day/week) use of omega-3, fish oil, or other supplements or functional foods containing docosahexaenoic acid (at daily doses > 200 mg).
- Known allergy to soy or corn.
- Continued intake of supplements containing Vitamin C, Vitamin E or β-carotene exceeding the DRI, or other anti-oxidant supplements.
- Symptomatic but untreated cholelithiasis.
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 |
|---|---|---|
| Docosahexaenoic acid (DHA)Participants will take 11 capsules of DHA oil for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery. | Dietary supplement | DHA |
| Placebo oral capsuleParticipants will take 11 capsules of placebo (corn/soy oil blend) for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery. | Drug | Placebo |
Primary outcome
Percent change in Ki67 index from baseline to surgical excision.
Time frame: Pre-intervention (on the baseline biopsy) and post- intervention (at the time of surgical excision).
Ki67 will be measured by image analysis at baseline biopsy and at experimental end (surgical excision).
6 secondary outcomes
Percent of DHA in plasma phospholipids between DHA and placebo arms.
Time frame: At day 0 and day 20 of cycles 1 to 6 of chemotherapy (each cycle is 20 days).
Change in immune function (e.g. ability to produce IL-2 after stimulation) following DHA supplementation in combination with chemotherapy.
Time frame: Baseline (within 21 days before cycle 1 of chemotherapy) and at the end of chemotherapy cycle 3 (each cyle is 20 days)
Age of participants and other factors affecting DHA incorporation
Time frame: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
Percent change on markers of apoptosis (e.g. caspase-3) following DHA or placebo supplementation.
Time frame: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
Pathological complete response rate
Time frame: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
Comparison of rate of chemotherapy associated grade 3 and 4 toxicities between treatment arms.
Time frame: At day 20 of chemotherapy cycles 1 to 6 (each cycle is 20 days).
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 4 Nov 2026.
- Background: PubMed 31530611Newell M, Mackey JR, Bigras G, Alvarez-Camacho M, Goruk S, Ghosh S, Schmidt A, Miede D, Chisotti A, Postovit L, Baker K, Mazurak V, Courneya K, Berendt R, Dong WF, Wood G, Basi SK, Joy AA, King K, Meza-Junco J, Zhu X, Field C. Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial. BMJ Open. 2019 Sep 17;9(9):e030502. doi: 10.1136/bmjopen-2019-030502.
- Derived from this study: PubMed 40315249Douglas CM, Newell M, Goruk S, Courneya KS, Ghosh S, Joy AA, Munhoz J, Field CJ. Exploratory outcomes of the DHA WIN randomized controlled trial: Supplementing women with docosahexaenoic acid did not reduce the impact of neoadjuvant breast cancer chemotherapy on quality of life or exercise behaviour. PLoS One. 2025 May 2;20(5):e0322178. doi: 10.1371/journal.pone.0322178. eCollection 2025.
- Individual participant dataSharing planned: Yes. The Cross Cancer Institute and the University of Alberta encourages and supports the responsible and ethical sharing of data from clinical trials. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov.
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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.
John Mackey, MD principal investigator
Cross Cancer Institute
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 Docosahexaenoic acid (DHA) in people with Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Percent change in Ki67 index from baseline to surgical excision. (time frame: Pre-intervention (on the baseline biopsy) and post- intervention (at the time of surgical excision).). 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 NCT03831178, which also lists 2 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 4 Nov 2026.