Breast CancerUPLIFT-BCNCT05371847
Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity
A study testing assessment for upper limb dysfunction and retest assessment in people with Breast Cancer, run by KU Leuven at 1 site in Belgium.
Trial summary
Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- assessment for upper limb dysfunction and retest assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Apr 2022to Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer.
- Patients who receive adjuvant radiotherapy .
- Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant
- Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent
- Healthy women and men(quickDASH<15) age- and gender-matched with a breast cancer patient from the main study
- Volunteers who can comply with the protocol at baseline assessment and willing to provide written informed consent
Who cannot join
- BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery
- And/or with a diagnosis of a neurological or rheumatological condition, diabetes,
- And/or BCS who are not available the entire duration of the study
- History of breast cancer
- Patients with a diagnosis of neurological or rheumatological condition, diabetes
Trial locations and contacts
1 site in 1 country.
Nieke Vets contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
An De Groef, Prof, +3216376668, an.degroef@kuleuven.be
Nieke Vets, PhD, nieke.vets@kuleuven.be
About this study
Official title: Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment.
The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment.
This study aims to find reliable and valid assessment methods for the prognostic factors and upper limb function itself in a small group of BCS and healthy volunteers.
- Conditions
- Breast Cancer
- Being tested
- assessment for upper limb dysfunction, retest assessment
- Keywords
- upper limb dysfunction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment for upper limb dysfunctionOther
clinical assessments and questionnaires
retest assessmentOther
For the test-retest reliability testing, participants will be invited to have an additional appointment approximately 1 week after the main assessment.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer patients | Active comparator | Women and men in the prospective cohort study will be invited to participate in this additional validity and/or reliability testing Receives: Other: assessment for upper limb dysfunction; Other: retest assessment |
| healthy volunteers | Active comparator | age- and gender-matched Receives: Other: assessment for upper limb dysfunction; Other: retest assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of measurements with MyotonPro
Inter- and intra-rater reliability will be tested. The MyotonPRO assessment for soft-tissue stiffness and elasticity will take place at the pectoralis major, upper trapezius, infraspinatus and teres major region, from which a mean stiffness index (N/m) will be calculated.
approximately 1 week between test \& retest
Measured: 1 week
Validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer
The validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer (MAP-BC evaluation tool), developed during PhD project of Prof. An De Groef will be investigated. This clinical assessment tool consists of the assessment of soft-tissue adhesion at 7 locations at the upper limb region: axillary and breast region scars, pectoral region, axilla, frontal chest wall, lateral chest wall and the inframammary fold. At each location, the degree of the adhesions will be scored at three levels (skin, superficial and deep) on a 4-point scale (between no adhesions and very stiff adhesions).
results will be compared with the results of the Myoton pro. approximately 1 week between test \& retest
Measured: 1 week
Validity of palpation for general stiffness
Palpation for general tissue stiffness scored on a Linkert Scale (0-5) at the different locations will be explored and the sum of total score of all locations will be calculated (0-35).
results will be compared with the results of the Myoton pro. approximately 1 week between test \& retest
Measured: 1 week
Reliability for the assessment of movement functions
The reliability of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer.
The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer.
approximately 1 week between test \& retest
Measured: 1 week
Construct validity for the assessment of movement functions
The validity of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer.
The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer.
approximately 1 week between test \& retest
Measured: 1 week
Validity of machine learning model for Upper limb functioning from ActiGraph sensors for breast cancer survivors
The accelerometer to evaluate upper limb functioning will be validated against video annotated data as proposed by Lum and colleagues. Established methods use a machine learning pipeline to accurately and automatically recognize functional upper limb activities from accelerometer data in healthy subjects. These models will be evaluated against video annotated data to assess accuracy and correlation for our subsample of breast cancer survivors.
approximately 1 week between test \& retest
Measured: 1 week
Validity of the use of hot/cold tubes for temperature sensations
Hot/cold tubes will be used for the cold and heat detection, but to validate this assessment method is will be compared with thermorollers.
approximately 1 week between test \& retest
Measured: 1 week
Validity of the assessment of upper limb activities through accelerometry
The accelerometer will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model.
approximately 1 week between test \& retest
Measured: 1 week
Validity of the assessment of upper limb activities: quickDASH
The quickDASH will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model.
The QuickDASH is a shortened version of the DASH Outcome Measure. The QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability
approximately 1 week between test \& retest
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start26 Apr 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Vrije Universiteit Brussel
- Responsible party
- Principal investigator, An De Groef, KU Leuven
- Investigators
- An De Groef, Prof. Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371847
- Sponsor's protocol ID
- s66248-aim2
- Acronym
- UPLIFT-BC
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Groef A, Van der Gucht E, Dams L, Evenepoel M, Teppers L, Toppet-Hoegars J, De Baets L. The association between upper limb function and variables at the different domains of the international classification of functioning, disability and health in women after breast cancer surgery: a systematic review. Disabil Rehabil. 2022 Apr;44(8):1176-1189. doi: 10.1080/09638288.2020.1800835. Epub 2020 Aug 8.
PubMed 32772650De Groef A, Van Kampen M, Vervloesem N, De Geyter S, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. An evaluation tool for myofascial adhesions in patients after breast cancer (MAP-BC evaluation tool): Development and interrater reliability. PLoS One. 2017 Jun 9;12(6):e0179116. doi: 10.1371/journal.pone.0179116. eCollection 2017.
PubMed 28598978Yang EJ, Park WB, Seo KS, Kim SW, Heo CY, Lim JY. Longitudinal change of treatment-related upper limb dysfunction and its impact on late dysfunction in breast cancer survivors: a prospective cohort study. J Surg Oncol. 2010 Jan 1;101(1):84-91. doi: 10.1002/jso.21435.
PubMed 19924721Kilbreath SL, Refshauge KM, Beith JM, Ward LC, Lee M, Simpson JM, Hansen R. Upper limb progressive resistance training and stretching exercises following surgery for early breast cancer: a randomized controlled trial. Breast Cancer Res Treat. 2012 Jun;133(2):667-76. doi: 10.1007/s10549-012-1964-1.
PubMed 22286332Lum PS, Shu L, Bochniewicz EM, Tran T, Chang LC, Barth J, Dromerick AW. Improving Accelerometry-Based Measurement of Functional Use of the Upper Extremity After Stroke: Machine Learning Versus Counts Threshold Method. Neurorehabil Neural Repair. 2020 Dec;34(12):1078-1087. doi: 10.1177/1545968320962483. Epub 2020 Nov 5.
PubMed 33150830
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05371847
- Acronym / sponsor ID
- UPLIFT-BC / s66248-aim2
- Conditions
- Breast Cancer
- Keywords
- upper limb dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Vrije Universiteit Brussel
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 12 May 2022 (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.
Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment.
The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment.
This study aims to find reliable and valid assessment methods for the prognostic factors and upper limb function itself in a small group of BCS and healthy volunteers.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast cancer patients | Active comparator | Other: assessment for upper limb dysfunction, Other: retest assessmentWomen and men in the prospective cohort study will be invited to participate in this additional validity and/or reliability testing |
| healthy volunteers | Active comparator | Other: assessment for upper limb dysfunction, Other: retest assessmentage- and gender-matched |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer.
- Patients who receive adjuvant radiotherapy .
- Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant
- Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent
- Healthy women and men(quickDASH<15) age- and gender-matched with a breast cancer patient from the main study
Key exclusion criteria (5 listed)
- BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery
- And/or with a diagnosis of a neurological or rheumatological condition, diabetes,
- And/or BCS who are not available the entire duration of the study
- History of breast cancer
- Patients with a diagnosis of neurological or rheumatological condition, diabetes
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 |
|---|---|---|
| assessment for upper limb dysfunctionclinical assessments and questionnaires | Other | breast cancer patients, healthy volunteers |
| retest assessmentFor the test-retest reliability testing, participants will be invited to have an additional appointment approximately 1 week after the main assessment. | Other | breast cancer patients, healthy volunteers |
Primary outcome
Reliability of measurements with MyotonPro
Time frame: 1 week
Inter- and intra-rater reliability will be tested. The MyotonPRO assessment for soft-tissue stiffness and elasticity will take place at the pectoralis major, upper trapezius, infraspinatus and teres major region, from which a mean stiffness index (N/m) will be calculated. approximately 1 week between test \& retest
Validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer
Time frame: 1 week
The validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer (MAP-BC evaluation tool), developed during PhD project of Prof. An De Groef will be investigated. This clinical assessment tool consists of the assessment of soft-tissue adhesion at 7 locations at the upper limb region: axillary and breast region scars, pectoral region, axilla, frontal chest wall, lateral chest wall and the inframammary fold. At each location, the degree of the adhesions will be scored at three levels (skin, superficial and deep) on a 4-point scale (between no adhesions and very stiff adhesions). results will be compared with the results of the Myoton pro. approximately 1 week between test \& retest
Validity of palpation for general stiffness
Time frame: 1 week
Palpation for general tissue stiffness scored on a Linkert Scale (0-5) at the different locations will be explored and the sum of total score of all locations will be calculated (0-35). results will be compared with the results of the Myoton pro. approximately 1 week between test \& retest
Reliability for the assessment of movement functions
Time frame: 1 week
The reliability of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer. The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer. approximately 1 week between test \& retest
Construct validity for the assessment of movement functions
Time frame: 1 week
The validity of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer. The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer. approximately 1 week between test \& retest
Validity of machine learning model for Upper limb functioning from ActiGraph sensors for breast cancer survivors
Time frame: 1 week
The accelerometer to evaluate upper limb functioning will be validated against video annotated data as proposed by Lum and colleagues. Established methods use a machine learning pipeline to accurately and automatically recognize functional upper limb activities from accelerometer data in healthy subjects. These models will be evaluated against video annotated data to assess accuracy and correlation for our subsample of breast cancer survivors. approximately 1 week between test \& retest
Validity of the use of hot/cold tubes for temperature sensations
Time frame: 1 week
Hot/cold tubes will be used for the cold and heat detection, but to validate this assessment method is will be compared with thermorollers. approximately 1 week between test \& retest
Validity of the assessment of upper limb activities through accelerometry
Time frame: 1 week
The accelerometer will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model. approximately 1 week between test \& retest
Validity of the assessment of upper limb activities: quickDASH
Time frame: 1 week
The quickDASH will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model. The QuickDASH is a shortened version of the DASH Outcome Measure. The QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability approximately 1 week between test \& retest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 32772650De Groef A, Van der Gucht E, Dams L, Evenepoel M, Teppers L, Toppet-Hoegars J, De Baets L. The association between upper limb function and variables at the different domains of the international classification of functioning, disability and health in women after breast cancer surgery: a systematic review. Disabil Rehabil. 2022 Apr;44(8):1176-1189. doi: 10.1080/09638288.2020.1800835. Epub 2020 Aug 8.
- Background: PubMed 28598978De Groef A, Van Kampen M, Vervloesem N, De Geyter S, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. An evaluation tool for myofascial adhesions in patients after breast cancer (MAP-BC evaluation tool): Development and interrater reliability. PLoS One. 2017 Jun 9;12(6):e0179116. doi: 10.1371/journal.pone.0179116. eCollection 2017.
- Background: PubMed 19924721Yang EJ, Park WB, Seo KS, Kim SW, Heo CY, Lim JY. Longitudinal change of treatment-related upper limb dysfunction and its impact on late dysfunction in breast cancer survivors: a prospective cohort study. J Surg Oncol. 2010 Jan 1;101(1):84-91. doi: 10.1002/jso.21435.
- Background: PubMed 22286332Kilbreath SL, Refshauge KM, Beith JM, Ward LC, Lee M, Simpson JM, Hansen R. Upper limb progressive resistance training and stretching exercises following surgery for early breast cancer: a randomized controlled trial. Breast Cancer Res Treat. 2012 Jun;133(2):667-76. doi: 10.1007/s10549-012-1964-1.
- Background: PubMed 33150830Lum PS, Shu L, Bochniewicz EM, Tran T, Chang LC, Barth J, Dromerick AW. Improving Accelerometry-Based Measurement of Functional Use of the Upper Extremity After Stroke: Machine Learning Versus Counts Threshold Method. Neurorehabil Neural Repair. 2020 Dec;34(12):1078-1087. doi: 10.1177/1545968320962483. Epub 2020 Nov 5.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Nieke Vets contact
An De Groef, Prof. Dr. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment for upper limb dysfunction and retest assessment in people with Breast Cancer, run by KU Leuven at 1 site in Belgium.
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 5 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 An De Groef, Prof. Dr. (003216376668, an.degroef@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of measurements with MyotonPro (time frame: 1 week). The study lists 9 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 NCT05371847, which also lists 5 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 1 May 2024.