Metastatic Breast CancerNCT04129346
Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
A study testing Fit2ThriveMB App, Fitbit and Physical Activity Coaching Calls in people with Metastatic Breast Cancer and Obesity, run by Northwestern University at 1 site in United States.
Trial summary
This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, Obesity
- What is being tested?
- Fit2ThriveMB App, Fitbit and Physical Activity Coaching Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female; ≥18 years of age
- Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify).
- Fluent in spoken and written English
- Own a smartphone
- Have access to the internet to complete assessments
- Self-report engaging in <150 minutes of moderate to vigorous PA per week.
Who cannot join
- Untreated brain metastases
- Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
- Current enrollment in another dietary or PA trial
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.
Read the detailed description
The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mHealth intervention to increase PA in metastatic breast cancer (MBC) patients using a two-arm randomized control trial (RCT). We will also examine the effects of the intervention on symptom burden, quality of life, and functional performance. Inactive MBC patients will be assigned to Fit2ThriveMB or education control. Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. Participants in the education control will be asked to download the app cancer.net from the American Society of Clinical Oncology, will receive educational materials and calls during the intervention period and the Fitbit following completion of 12 week assessments.
- Conditions
- Metastatic Breast Cancer, Obesity
- Being tested
- Fit2ThriveMB App, Fitbit, Physical Activity Coaching Calls, Healthy Living Coaching Calls, Cancer.net app
- Keywords
- Inactivity, Breast Cancer, Metastatic Breast Cancer, Quality of life, Sedentary
- Medical subject headings
- Breast Neoplasms, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit2ThriveMB AppBehavioural
The Fit2thriveMB app will encourage participants to increase their physical activity. Participants will be provided with educational information on physical activity and effective behavior change strategies for incorporating more physical activity into their daily lives to increase their step count. Participants will be prompted each morning to report the intensity of their symptom burden (0 to 10). Based on their symptom rating and their previous day's step counts, participants will be provided with three different options or levels of goals for that day to either increase or decrease 10-20% or remain constant.
FitbitBehavioural
The Fitbit measures PA intensity, steps, and heart rate and syncs directly with the smartphone and will automatically sync with the Fit2ThriveMB app and provide Fitbit data to the study team in real-time.
Physical Activity Coaching CallsBehavioural
Participants will receive weekly coaching calls which will: a) provide feedback on the previous week's symptom burden and progress on PA goals; b) review personalized goals and strategies for increasing PA for the next week; c) provide instruction on effective behavioral change techniques
Healthy Living Coaching CallsBehavioural
Participants will receive weekly calls that will cover health and well-being topics for instance: symptom and stress management, healthy diet, hydration, sun safety, sleep hygiene, and meditation.
Cancer.net appBehavioural
Cancer.net app content includes information about health and well-being, treatment guidelines specific to cancer type, symptom tracking and medication tracking
| Study group | Role | What they receive |
|---|---|---|
| Fit2ThriveMB | Experimental | Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. Receives: Behavioral: Fit2ThriveMB App; Behavioral: Fitbit; Behavioral: Physical Activity Coaching Calls |
| Healthy Living Control | Active comparator | Participants in the healthy living group will receive the American Society of Cancer Oncologists smartphone app, cancer.net. They will also receive calls during the intervention period and the Fitbit following completion of 12 week assessments Receives: Behavioral: Healthy Living Coaching Calls; Behavioral: Cancer.net app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period
Feasibility will be assessed via participant retention during the intervention period [(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized].
Measured: 12 weeks
Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients
Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app. This measure the average percentage of days each participant in the Fit2ThriveMB intervention group wore the Fitbit.
Measured: 12 weeks
Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients
Acceptability will be measured via a process evaluation of perceptions of MBC patients' experiences with Fit2ThriveMB. Acceptability will be measured as the number of intervention participants who are satisfied/very satisfied with their overall study experience.
Measured: 12 weeks
Secondary outcomes (12)
Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients
Physical activity will be measured at baseline and at 12 weeks. The change between physical activity at baseline and 12-weeks will be assessed. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Measured: Baseline and 12 weeks
Change in Quality of Life From From Baseline to 12-weeks
Quality of life will be measured at baseline and 12 weeks using the Functional Assessment of Cancer Therapy-Breast (FACT-B). Totals scores range from 0 to 148. Higher scores indicate better quality of life.
Measured: Baseline and 12 weeks
Change in Anxiety From Baseline to 12-weeks
Anxiety will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a health measure. T-scores range from 37.1 to 83.1. Higher scores indicate more anxiety. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Baseline and 12 weeks
Change in Depression From Baseline to 12-weeks
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Baseline and 12 weeks
Change in Fatigue From Baseline to 12-weeks
Fatigue will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Baseline and 12 weeks
Change in Pain Interference From Baseline to 12-weeks
Pain Interference will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Interference 8a health measure. T-scores range from 40.7 to 77.0 Higher scores indicate more pain interference.
Measured: Baseline and 12 weeks
Change in Physical Function From Baseline to 12-weeks
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Baseline and 12 weeks
Change in Sleep Disturbance From Baseline to 12-weeks
Sleep disturbance will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-sleep disturbance 8a health measure. T-scores range from 30.5 to 77.5. Higher scores more sleep disturbance. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Measured: Baseline and 12 weeks
Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks
Participants will complete the Short Physical Performance Battery which includes assessments of gait speed, chair stands and standing balance that are combined to obtain a SPPB score. This test will be conducted at baseline and 12 weeks. SPPB scores range from 0 to 12. Higher scores mean better physical functioning.
Measured: Baseline and 12 weeks
Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks
The Senior Fitness Test measures physical function. The arm curl test assesses the number of times (repetitions) a 5lb hand-weight is curled in 30 seconds. The 2-minute step test evaluates the number of times (repetitions) the right knee reaches a distance half way between the iliac crest and patella during 2-minutes. Increased number of repetitions on both tests represents better physical function.
Measured: Baseline and 12 weeks
Change in 6-minute Walk Test Distance Between Baseline and 12-weeks.
Participants will complete a 6 minute walk test at baseline and 12 weeks. Distance is measured in meters. Increases in distance represent better performance.
Measured: Baseline and 12 weeks
Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks
The Senior Fitness Test measures physical function. The one leg stand test assesses how long an individual can stand on each of their feet (right and left) in seconds up to 30-seconds. Increases in time on the one leg stand tests indicate better functioning. The 8-foot up and go test assesses how long it takes in seconds to stand from a chair, walk 8 feet around an object and return to sitting. Decreases in time indicate better functioning.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start26 Nov 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Siobhan M Phillips, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129346
- Sponsor's protocol ID
- SP00049673
- Other IDs
- R21CA239130
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2019
- Last updated
- 10 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy. We welcome inquiries by investigators who are not associated with the study to review or analyze data that we have collected. All requests for data sharing will be handled by the PI, Dr. Phillips, in conjunction with co-investigators, on a case by case basis to ensure that the proposed work does not conflict with planned analyses; we will also establish that the proposed project has sufficient scientific merit before proceeding.
Publications
Phillips SM, Starikovsky J, Solk P, Desai R, Reading JM, Hasanaj K, Wang SD, Cullather E, Lee J, Song J, Spring B, Gradishar W. Feasibility and preliminary effects of the Fit2ThriveMB pilot physical activity promotion intervention on physical activity and patient reported outcomes in individuals with metastatic breast cancer. Breast Cancer Res Treat. 2024 Nov;208(2):391-403. doi: 10.1007/s10549-024-07432-5. Epub 2024 Jul 16.
PubMed 39014267Phillips S, Solk P, Welch W, Auster-Gussman L, Lu M, Cullather E, Torre E, Whitaker M, Izenman E, La J, Lee J, Spring B, Gradishar W. A Technology-Based Physical Activity Intervention for Patients With Metastatic Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 23;10(4):e24254. doi: 10.2196/24254.
PubMed 33890857
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
- ClinicalTrials.gov ID
- NCT04129346
- Acronym / sponsor ID
- SP00049673
- Conditions
- Metastatic Breast Cancer, Obesity
- Keywords
- Inactivity, Breast Cancer, Metastatic Breast Cancer, Quality of life, Sedentary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 10 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.
Detailed description
The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mHealth intervention to increase PA in metastatic breast cancer (MBC) patients using a two-arm randomized control trial (RCT). We will also examine the effects of the intervention on symptom burden, quality of life, and functional performance. Inactive MBC patients will be assigned to Fit2ThriveMB or education control. Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. Participants in the education control will be asked to download the app cancer.net from the American Society of Clinical Oncology, will receive educational materials and calls during the intervention period and the Fitbit following completion of 12 week assessments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fit2ThriveMB | Experimental | Behavioral: Fit2ThriveMB App, Behavioral: Fitbit, Behavioral: Physical Activity Coaching CallsParticipants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. |
| Healthy Living Control | Active comparator | Behavioral: Healthy Living Coaching Calls, Behavioral: Cancer.net appParticipants in the healthy living group will receive the American Society of Cancer Oncologists smartphone app, cancer.net. They will also receive calls during the intervention period and the Fitbit following completion of 12 week assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female; ≥18 years of age
- Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify).
- Fluent in spoken and written English
- Own a smartphone
- Have access to the internet to complete assessments
Key exclusion criteria (3 listed)
- Untreated brain metastases
- Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
- Current enrollment in another dietary or PA trial
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 |
|---|---|---|
| Fit2ThriveMB AppThe Fit2thriveMB app will encourage participants to increase their physical activity. Participants will be provided with educational information on physical activity and effective behavior change strategies for incorporating more physical activity into their daily lives to increase their step count. Participants will be prompted each morning to report the intensity of their symptom burden (0 to 10). Based on their symptom rating and their previous day's step counts, participants will be provided with three different options or levels of goals for that day to either increase or decrease 10-20% or remain constant. | Behavioural | Fit2ThriveMB |
| FitbitThe Fitbit measures PA intensity, steps, and heart rate and syncs directly with the smartphone and will automatically sync with the Fit2ThriveMB app and provide Fitbit data to the study team in real-time. | Behavioural | Fit2ThriveMB |
| Physical Activity Coaching CallsParticipants will receive weekly coaching calls which will: a) provide feedback on the previous week's symptom burden and progress on PA goals; b) review personalized goals and strategies for increasing PA for the next week; c) provide instruction on effective behavioral change techniques | Behavioural | Fit2ThriveMB |
| Healthy Living Coaching CallsParticipants will receive weekly calls that will cover health and well-being topics for instance: symptom and stress management, healthy diet, hydration, sun safety, sleep hygiene, and meditation. | Behavioural | Healthy Living Control |
| Cancer.net appCancer.net app content includes information about health and well-being, treatment guidelines specific to cancer type, symptom tracking and medication tracking | Behavioural | Healthy Living Control |
Primary outcome
Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period
Time frame: 12 weeks
Feasibility will be assessed via participant retention during the intervention period [(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized].
Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients
Time frame: 12 weeks
Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app. This measure the average percentage of days each participant in the Fit2ThriveMB intervention group wore the Fitbit.
Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients
Time frame: 12 weeks
Acceptability will be measured via a process evaluation of perceptions of MBC patients' experiences with Fit2ThriveMB. Acceptability will be measured as the number of intervention participants who are satisfied/very satisfied with their overall study experience.
12 secondary outcomes
Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients
Time frame: Baseline and 12 weeks
Change in Quality of Life From From Baseline to 12-weeks
Time frame: Baseline and 12 weeks
Change in Anxiety From Baseline to 12-weeks
Time frame: Baseline and 12 weeks
Change in Depression From Baseline to 12-weeks
Time frame: Baseline and 12 weeks
Change in Fatigue From Baseline to 12-weeks
Time frame: Baseline and 12 weeks
Change in Pain Interference From Baseline to 12-weeks
Time frame: Baseline and 12 weeks
Change in Physical Function From Baseline to 12-weeks
Time frame: Baseline and 12 weeks
Change in Sleep Disturbance From Baseline to 12-weeks
Time frame: Baseline and 12 weeks
Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks
Time frame: Baseline and 12 weeks
Change in 6-minute Walk Test Distance Between Baseline and 12-weeks.
Time frame: Baseline and 12 weeks
Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39014267Phillips SM, Starikovsky J, Solk P, Desai R, Reading JM, Hasanaj K, Wang SD, Cullather E, Lee J, Song J, Spring B, Gradishar W. Feasibility and preliminary effects of the Fit2ThriveMB pilot physical activity promotion intervention on physical activity and patient reported outcomes in individuals with metastatic breast cancer. Breast Cancer Res Treat. 2024 Nov;208(2):391-403. doi: 10.1007/s10549-024-07432-5. Epub 2024 Jul 16.
- Derived from this study: PubMed 33890857Phillips S, Solk P, Welch W, Auster-Gussman L, Lu M, Cullather E, Torre E, Whitaker M, Izenman E, La J, Lee J, Spring B, Gradishar W. A Technology-Based Physical Activity Intervention for Patients With Metastatic Breast Cancer (Fit2ThriveMB): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 23;10(4):e24254. doi: 10.2196/24254.
- Individual participant dataSharing planned: Yes. Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy. We welcome inquiries by investigators who are not associated with the study to review or analyze data that we have collected. All requests for data sharing will be handled by the PI, Dr. Phillips, in conjunction with co-investigators, on a case by case basis to ensure that the proposed work does not conflict with planned analyses; we will also establish that the proposed project has sufficient scientific merit before proceeding.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit2ThriveMB App, Fitbit and Physical Activity Coaching Calls in people with Metastatic Breast Cancer and Obesity, run by Northwestern University 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 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT04129346, 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 10 Nov 2022.