Breast CancerHealthyMENCT06133959
Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer
A study testing The-Optimal-Lymph-Flow (TOLF) Program in people with Breast Cancer, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
The goal of this two-phase project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- The-Optimal-Lymph-Flow (TOLF) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants are Black and Hispanic women (over age 18) with lymphatic pain following breast cancer treatment. These women will be recruited for the Phase I focus groups (N=24), and the Phase II RCT (N=60). Participants will include women who 1) have received surgical treatment for breast cancer at least 3 months prior to the study enrollment, 2) report persistent or intermittent pain/aching/soreness in the ipsilateral body or upper limb; 3) self-identify as either Black or Hispanic; and 4) are able to understand the study protocols presented in English.
Who cannot join
- Exclusion criteria include: 1) presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating oncologist or other staff, or study staff interactions that would contraindicate safe study participation; 2) known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions; 3) were diagnosed or treated for lymphedema.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Kansas City
Kansas City, Missouri, 64108
Mei R Fu, PhD, 973-986-1758, mei.fu@umkc.edu
Cynthia Russel Lippincott, PhD, 816-235-2661, russellc@umkc.edu
About this study
The goal of this two-phase project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients. The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. Specific aims are to:
Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. The investigators will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of Black and Hispanic women.
Aim 2: Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain management) of the culturally appropriate behavioral interventions.
Read the detailed description
PURPOSE/SPECIFIC AIMS The purpose of this project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients. The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. Specific aims are to:
Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. The investigators will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of Black and Hispanic women.
Aim 2: Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain management) of the culturally appropriate behavioral interventions.
RATIONALE/SIGNIFICANCE OF THE STUDY. Lymphatic pain refers to pain, aching or soreness in the ipsilateral body or upper limb following breast cancer treatment. More than half of the 3.8 million women with breast cancer suffer lymphatic pain which leads to impaired daily living function, psychological distress, and compromised QOL. Most importantly, lymphatic pain is significantly associated with lymphedema, a chronic and incurable condition caused by an abnormal accumulation of lymph fluid. Black and Hispanic women are three times as likely to suffer from lymphedema compared to White women. Timely intervention for lymphatic pain can decrease the risk and severity of lymphedema. However, there are persistent barriers to timely interventions faced by Black and Hispanic women with breast cancer - a group at high risk for developing lymphedema, pain, and other negative breast cancer related outcomes.
THEORETICAL FRAMEWORK. Self-efficacy theory guides the project. Behavioral pain interventions focus on training patients on self-management skills to be implemented in their daily lives.
MAIN RESEARCH VARIABLES. Behavioral pain intervention (IV), Outcomes (DVs): lymphatic pain, pain severity and interference, lymph fluid level, daily living function, psychological distress, QOL, self-efficacy for pain management.
DESIGN. Qualitative and randomized clinical trial (RCT)
SETTING. All participants will be recruited from UMKC University Health and surrounding communities.
SAMPLES. Black and Hispanic women with lymphatic pain
METHODS. Focus groups will be conducted with Black and Hispanic women to gather data that will lead to culturally appropriate adaptation of TOLF. Then, a pilot RCT will be used to examine feasibility, acceptability, and evidence of future efficacy of this culturally adapted intervention.
IMPLICATIONS FOR PRACTICE. The successful completion of the project will advance health equity in pain and lymphedema by making this culturally appropriate, highly accessible, and effective behavioral intervention available to Black and Hispanic women.
- Conditions
- Breast Cancer
- Being tested
- The-Optimal-Lymph-Flow (TOLF) Program
- Keywords
- pain, lymphedema, breast cancer, behavior, intervention
- Medical subject headings
- Breast Neoplasms, Pain, Lymphedema, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The-Optimal-Lymph-Flow (TOLF) ProgramBehavioural
TOLF includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema, healthy diet, sleep hygiene, and daily lymphatic exercises. It has 8 avatar videos with step-by-step instructions for TOLF lymphatic exercises to promote lymph flow. It is expected that participants will complete initial in-person or telehealth virtual 40-minute session, and 3 virtual telehealth sessions with each session for 20-minute over the course of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| e-Lymph Control | Active comparator | e-Lymph (Control). e-Lymph includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema. Receives: Behavioral: The-Optimal-Lymph-Flow (TOLF) Program |
| The-Optimal-Lymph Flow (TOLF) Program | Experimental | TOLF includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema, healthy diet, sleep hygiene, and daily lymphatic exercises. It has 8 avatar videos with step-by-step instructions for TOLF lymphatic exercises to promote lymph flow. Receives: Behavioral: The-Optimal-Lymph-Flow (TOLF) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic Pain
The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part I, a reliable and valid self-report instrument, is used to assess self-reported lymphatic pain, i.e., aching or soreness or tenderness.
Measured: Pre-intervention (0 week) and Post-intervention (13 week)
Pain Severity and Interference
Brief Pain Inventory-Short Form (BPI-SF) will be used to measure pain severity and interference. The measure demonstrated reliability and validity.65 The BPI-SF consists of four items assessing pain severity (worst, least, average, and current pain) and seven items assessing pain interference in the past week.
Measured: Pre-intervention (0 week) and Post-intervention (13 week)
Secondary outcomes (5)
Lymph Fluid Level
A bioelectrical impedance analysis (BIA) device is used to assess lymph fluid level. The device measures the resistance of the extracellular fluid (i.e. the impedance) in terms of the fluid ratio, taking into consideration the ratio between the dominant and non-dominant arms.
Measured: Pre-intervention (0 week) and Post-intervention (13 week)
Daily Living Function:
The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part II is used to measure activity of daily living (ADLs). The 13-item subscale of ADLs in BCLE-SEI Part II is used to assess self-reported difficulty in performing thirteen ADLs.
Measured: Pre-intervention (0 week) and Post-intervention (13 week)
Psychological Distress
The 12-item subscale of psychological/emotional distress subscale from the BCLE-SEI Part II is used to assess the distress of being frustrated, sad, guilt/self-blame, worried, irritable, fearful, angry, lonely, helpless, hopeless, anxious, and depressed. Cronbach's alpha for the psychological/emotional distress subscale was 0.91.
Measured: Pre-intervention (0 week) and Post-intervention (13 week)
Patients' Quality of life
Global Health Scale (PROMIS GHS) is used to measure quality of life (QOL) captures self-perception of QOL on a scale from 1 (poor), 2 (fair), 3 (good), 4 (very good) to 5 (excellent). This tool has good reliability (a= 0.80-0.86).
Measured: Pre-intervention (0 week) and Post-intervention (13 week)
Self-efficacy for Pain Management
The 5-item Chronic Pain Self-Efficacy Scale81 with good reliability69-70 is used to assess patients' certainty about their degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication.
Measured: Pre-intervention (0 week) and Post-intervention (13 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei R Fu, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133959
- Sponsor's protocol ID
- 2098673
- Other IDs
- RE33
- Acronym
- HealthyME
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share any individual participant data during and after study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT06133959
- Acronym / sponsor ID
- HealthyME / 2098673
- Conditions
- Breast Cancer
- Keywords
- pain, lymphedema, breast cancer, behavior, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
The goal of this two-phase project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients. The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. Specific aims are to:
Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. The investigators will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of Black and Hispanic women.
Aim 2: Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain management) of the culturally appropriate behavioral interventions.
Detailed description
PURPOSE/SPECIFIC AIMS The purpose of this project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients. The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. Specific aims are to:
Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. The investigators will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of Black and Hispanic women.
Aim 2: Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain management) of the culturally appropriate behavioral interventions.
RATIONALE/SIGNIFICANCE OF THE STUDY. Lymphatic pain refers to pain, aching or soreness in the ipsilateral body or upper limb following breast cancer treatment. More than half of the 3.8 million women with breast cancer suffer lymphatic pain which leads to impaired daily living function, psychological distress, and compromised QOL. Most importantly, lymphatic pain is significantly associated with lymphedema, a chronic and incurable condition caused by an abnormal accumulation of lymph fluid. Black and Hispanic women are three times as likely to suffer from lymphedema compared to White women. Timely intervention for lymphatic pain can decrease the risk and severity of lymphedema. However, there are persistent barriers to timely interventions faced by Black and Hispanic women with breast cancer - a group at high risk for developing lymphedema, pain, and other negative breast cancer related outcomes.
THEORETICAL FRAMEWORK. Self-efficacy theory guides the project. Behavioral pain interventions focus on training patients on self-management skills to be implemented in their daily lives.
MAIN RESEARCH VARIABLES. Behavioral pain intervention (IV), Outcomes (DVs): lymphatic pain, pain severity and interference, lymph fluid level, daily living function, psychological distress, QOL, self-efficacy for pain management.
DESIGN. Qualitative and randomized clinical trial (RCT)
SETTING. All participants will be recruited from UMKC University Health and surrounding communities.
SAMPLES. Black and Hispanic women with lymphatic pain
METHODS. Focus groups will be conducted with Black and Hispanic women to gather data that will lead to culturally appropriate adaptation of TOLF. Then, a pilot RCT will be used to examine feasibility, acceptability, and evidence of future efficacy of this culturally adapted intervention.
IMPLICATIONS FOR PRACTICE. The successful completion of the project will advance health equity in pain and lymphedema by making this culturally appropriate, highly accessible, and effective behavioral intervention available to Black and Hispanic women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention and control arms
| Arm | Type | Receives |
|---|---|---|
| e-Lymph Control | Active comparator | Behavioral: The-Optimal-Lymph-Flow (TOLF) Programe-Lymph (Control). e-Lymph includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema. |
| The-Optimal-Lymph Flow (TOLF) Program | Experimental | Behavioral: The-Optimal-Lymph-Flow (TOLF) ProgramTOLF includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema, healthy diet, sleep hygiene, and daily lymphatic exercises. It has 8 avatar videos with step-by-step instructions for TOLF lymphatic exercises to promote lymph flow. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants are Black and Hispanic women (over age 18) with lymphatic pain following breast cancer treatment. These women will be recruited for the Phase I focus groups (N=24), and the Phase II RCT (N=60). Participants will include women who 1) have received surgical treatment for breast cancer at least 3 months prior to the study enrollment, 2) report persistent or intermittent pain/aching/soreness in the ipsilateral body or upper limb; 3) self-identify as either Black or Hispanic; and 4) are able to understand the study protocols presented in English.
Key exclusion criteria (1 listed)
- Exclusion criteria include: 1) presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating oncologist or other staff, or study staff interactions that would contraindicate safe study participation; 2) known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions; 3) were diagnosed or treated for lymphedema.
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 |
|---|---|---|
| The-Optimal-Lymph-Flow (TOLF) ProgramTOLF includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema, healthy diet, sleep hygiene, and daily lymphatic exercises. It has 8 avatar videos with step-by-step instructions for TOLF lymphatic exercises to promote lymph flow. It is expected that participants will complete initial in-person or telehealth virtual 40-minute session, and 3 virtual telehealth sessions with each session for 20-minute over the course of 8 weeks. | Behavioural | The-Optimal-Lymph Flow (TOLF) Program, e-Lymph Control |
Primary outcome
Lymphatic Pain
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part I, a reliable and valid self-report instrument, is used to assess self-reported lymphatic pain, i.e., aching or soreness or tenderness.
Pain Severity and Interference
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Brief Pain Inventory-Short Form (BPI-SF) will be used to measure pain severity and interference. The measure demonstrated reliability and validity.65 The BPI-SF consists of four items assessing pain severity (worst, least, average, and current pain) and seven items assessing pain interference in the past week.
5 secondary outcomes
Lymph Fluid Level
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Daily Living Function:
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Psychological Distress
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Patients' Quality of life
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Self-efficacy for Pain Management
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. We will not share any individual participant data during and after study.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Mei R Fu principal investigator
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The-Optimal-Lymph-Flow (TOLF) Program in people with Breast Cancer, run by University of Missouri, Kansas City 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?
The sponsor lists 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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?
Contact Mei R Fu, PhD (9739861758, mei.fu@umkc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphatic Pain (time frame: Pre-intervention (0 week) and Post-intervention (13 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.