SarcopeniaNCT05241886
Evaluation of Sarcopenia With SARC-F and Anthropometric Measurement
An observational study of Sarcopenia and Older People, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the performance of determining the sarcopenia by anthropometric measurements (mid-upper arm circumference and calf circumference) added to the SARC-F questionnaire developed as a screening tool for the risk of sarcopenia in the community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Older People
- What is being tested?
- anthoropometric measurement, SARC- F questionnare
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling participants aged 65 and over who applied to the geriatrics outpatient clinic for any reason.
Who may be able to join
- participants who applied to the geriatrics outpatient clinic for any reason
Who cannot join
- Participants with an implanted pacemaker, severe mental illness, unable to walk, severe heart failure, severe renal failure, clinically visible edema, and unable to communicate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of Sarcopenia By Adding Anthropometric Measurements To The SARC-F Questionnaire
The aim of this study is to examine the performance of determining the sarcopenia by anthropometric measurements (mid-upper arm circumference and calf circumference) added to the SARC-F questionnaire developed as a screening tool for the risk of sarcopenia in the community-dwelling older adults. The risk of sarcopenia of the individuals over 65 years of age who applied to the Geriatrics Department of Ege University Medical Faculty Hospital Internal Diseases Department. was determined by the SARC-F questionnaire, muscle mass was established by bioelectrical impedance analysis, muscle strength was assessed by handgrip strength, physical performance was assessed by a 4-meter walking test and presence of malnutrition was assessed with an MNA-long form. For the diagnosis of sarcopenia; old (EWGSOP 1) and revised (EWGSOP 2) diagnostic criteria of Sarcopenia Study Group in Elderly Individuals of the European Union Geriatric Medicine Association were used. New parameters were obtained by adding calf circumference (SARC-CC) and mid-upper arm circumference (SARC-MUAC) measurements were added separately and together (SARC-CC-MUAC) to the SARC-F. For the calf circumference cut-off points of <31 cm and <33 cm and for the mid-upper arm circumference cut-off points of <25 cm and <31 cm were used for the sensitivity and specificity analyses.
Read the detailed description
The population of the research is individuals aged 65 and over who applied to Ege University Medical Faculty Hospital Internal Diseases Department, Geriatrics BD Outpatient Clinic. For statistical power analysis; When α=0.05 and the power of the study are 0.80, the minimum number of samples required for the study was determined as 190. The relevant sample size was calculated with the G-Power 3.0.8 package program.
Data collection tools:
- General information collection form: Investigator collect data about age, gender, chronic diseases, economic status, etc of participants
- Measurement of Muscle Mass, Muscle Strength, and Gait Speed Body composition analysis was determined by electrical bioimpedance using the Tanita MC-780 multi-frequency segmental Body Composition Analyzer (Tanita Corporation, Tokyo). The appendicular skeletal muscle mass (ASM) was calculated with the Janssen equation for EWGSOP criteria and Sergi equation for EWGSOP 2 criteria. The appendicular muscle mass index (ASMI) was calculated based on the equation: ASM(kg) /height (m2). Muscle strength (kg) was assessed with the Takei Grip Strength Dynamometer®. Handgrip strength (HS) measurements were made with the subjects in a sitting position, with the elbow and wrist in full extension, three times with an interval of five seconds on both hands, and the highest value among the measurement results was used for analysis. Gender-specific cut-offs were used to define low muscle strength (30 and 20 kg in males and females) for EWGSOP criteria, and (27 and 16 kg in males and females) for EWGSOP 2 criteria. Usual gait speed (m/s) was performed by the subjects walking 4 m with usual speed and ≤0.8 m/s was defined as low walking speed.
- Anthropometric measurement: In all participants, height was measured using a stadiometer to the nearest 0.1 cm, weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body mass index (BMI) was calculated by the weight (kg)/height (m2) equation. The calf circumference (CC) of participants was measured with an inflexible tape measure, in the sitting position, with the knee flexed to 90º, and the circumference of the widest part of the calf. Both the standard CC cut-off (<31 cm) and population-specific cut-off (<33 cm) were used and compared in SARC-CalF analysis. Mid upper arm circumference (MUAC) was measured in a stand position, the mid-point of the participant's left upper arm- located between the acromion and olecranon- was marked when the elbow bent to a 90o angle and measured with the inflexible tape around the marked midpoint with the participant's arm hung down naturally.
- Screening of sarcopenia risk and assessment of sarcopenia SARC-F, SARC-CalF, and SARC-MUAC were used for screening sarcopenia risk. For the SARC-F total score of ≥4, SARC-CalF ≥11, and SARC-MUAC≥11 were defined as positive sarcopenia risk. Investigator used EWGSOP and EWGSOP 2 criteria for sarcopenia diagnosis.
- Statistic analysis: SPSS 25.0 (SPSS Statistics; IBM, Armonk, NY) and MedCalc Statistical Software 19.1.6-free trial (MedCalc Software, Ostend, Belgium) statistical package programs were used for statistical analysis. The level of significance was defined as p<0.05.
For categorical variables, the data were presented as numbers (percentage). Continuous variables with normal or skewed distribution were presented as mean (standard deviation) or median (interquartile range), respectively. Group differences were investigated using the t-test for normally distributed data and the Mann-Whitney test for skewed data and the X2 or Fisher's exact test for categorical data was used. Using EWGSOP and EWGSOP 2 criteria as the reference standard, the investigator calculated the diagnostic value of the SARC-F, SARC-CalF- 31, and SARC-CalF-33 [sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy] for identifying sarcopenia. A receiver operating characteristics (ROC) curve was used to compare the overall accuracy of SARC-F, SARC-CalF-31, and SARC-CalF-33. The area under the ROC curve (AUC) and 95% confidence interval (CI) were calculated.
The exclusion criteria are as follows: an implanted pacemaker, severe mental illness, unable to walk, severe heart failure, severe renal failure, clinically visible edema, and unable to communicate.
Participants in which all the evaluations in the research protocol were carried out and answered all the questions.
- Conditions
- Sarcopenia, Older People
- Being tested
- anthoropometric measurement, SARC- F questionnare
- Keywords
- Sarcopenia, SARC-F, Calf circumference, Mid upper arm circumference, EWGSOP, EWGSOP 2
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthoropometric measurement, SARC- F questionnareOther
SARC-F, CC, MUAC
What is being measured
The primary outcome is the main question the study is designed to answer.
sarcopenia prevalance
number
Measured: Day 1
SARC-F score
number
Measured: Day 1
mid-upper arm circumference
cm
Measured: Day 1
calf circumference
cm
Measured: Day 1
Appendicular skeletal muscle mass index
kg/m2
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Jul 2018
- Primary completion2 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Ege 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Atik Altinok, Ege University
- Investigators
- yasemin A Atik-Altinok, PhD, Principal investigator, Ege UniversityDevrim Bozkurt, Assoc Prof, Study director, Ege UniversitySumru Savaş, Assoc Prof, Principal investigator, Ege UniversityReci Meseri, Assoc Prof, Principal investigator, Ege UniversityFulden Saraç, Prof Dr, Principal investigator, Ege UniversityFehmi Akçiçek, Prof Dr, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241886
- Sponsor's protocol ID
- Sarcopenia001
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abd-El-Gawad WM, Abou-Hashem RM, El Maraghy MO, Amin GE. The validity of Geriatric Nutrition Risk Index: simple tool for prediction of nutritional-related complication of hospitalized elderly patients. Comparison with Mini Nutritional Assessment. Clin Nutr. 2014 Dec;33(6):1108-16. doi: 10.1016/j.clnu.2013.12.005. Epub 2013 Dec 28.
PubMed 24418116Ates Bulut E, Soysal P, Dokuzlar O, Kocyigit SE, Aydin AE, Yavuz I, Isik AT. Validation of population-based cutoffs for low muscle mass and strength in a population of Turkish elderly adults. Aging Clin Exp Res. 2020 Sep;32(9):1749-1755. doi: 10.1007/s40520-019-01448-4. Epub 2020 Jan 2.
PubMed 31898170Bahat G, Yilmaz O, Kilic C, Oren MM, Karan MA. Performance of SARC-F in Regard to Sarcopenia Definitions, Muscle Mass and Functional Measures. J Nutr Health Aging. 2018;22(8):898-903. doi: 10.1007/s12603-018-1067-8.
PubMed 30272090Fu X, Tian Z, Thapa S, Sun H, Wen S, Xiong H, Yu S. Comparing SARC-F with SARC-CalF for screening sarcopenia in advanced cancer patients. Clin Nutr. 2020 Nov;39(11):3337-3345. doi: 10.1016/j.clnu.2020.02.020. Epub 2020 Feb 22.
PubMed 32143888Sergi G, De Rui M, Veronese N, Bolzetta F, Berton L, Carraro S, Bano G, Coin A, Manzato E, Perissinotto E. Assessing appendicular skeletal muscle mass with bioelectrical impedance analysis in free-living Caucasian older adults. Clin Nutr. 2015 Aug;34(4):667-73. doi: 10.1016/j.clnu.2014.07.010. Epub 2014 Jul 24.
PubMed 25103151da Luz MCL, Pinho CPS, Bezerra GKA, da Conceicao Chaves de Lemos M, da Silva Diniz A, Cabral PC. SARC-F and SARC-CalF in screening for sarcopenia in older adults with Parkinson's disease. Exp Gerontol. 2021 Feb;144:111183. doi: 10.1016/j.exger.2020.111183. Epub 2020 Dec 3.
PubMed 33279661Hajaoui M, Locquet M, Beaudart C, Reginster JY, Petermans J, Bruyere O. Sarcopenia: Performance of the SARC-F Questionnaire According to the European Consensus Criteria, EWGSOP1 and EWGSOP2. J Am Med Dir Assoc. 2019 Sep;20(9):1182-1183. doi: 10.1016/j.jamda.2019.05.021. No abstract available.
PubMed 31455509Drey M, Ferrari U, Schraml M, Kemmler W, Schoene D, Franke A, Freiberger E, Kob R, Sieber C. German Version of SARC-F: Translation, Adaption, and Validation. J Am Med Dir Assoc. 2020 Jun;21(6):747-751.e1. doi: 10.1016/j.jamda.2019.12.011. Epub 2020 Jan 21.
PubMed 31980396
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Sarcopenia By Adding Anthropometric Measurements To The SARC-F Questionnaire
- ClinicalTrials.gov ID
- NCT05241886
- Acronym / sponsor ID
- Sarcopenia001
- Conditions
- Sarcopenia, Older People
- Keywords
- Sarcopenia, SARC-F, Calf circumference, Mid upper arm circumference, EWGSOP, EWGSOP 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 16 Feb 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.
The aim of this study is to examine the performance of determining the sarcopenia by anthropometric measurements (mid-upper arm circumference and calf circumference) added to the SARC-F questionnaire developed as a screening tool for the risk of sarcopenia in the community-dwelling older adults. The risk of sarcopenia of the individuals over 65 years of age who applied to the Geriatrics Department of Ege University Medical Faculty Hospital Internal Diseases Department. was determined by the SARC-F questionnaire, muscle mass was established by bioelectrical impedance analysis, muscle strength was assessed by handgrip strength, physical performance was assessed by a 4-meter walking test and presence of malnutrition was assessed with an MNA-long form. For the diagnosis of sarcopenia; old (EWGSOP 1) and revised (EWGSOP 2) diagnostic criteria of Sarcopenia Study Group in Elderly Individuals of the European Union Geriatric Medicine Association were used. New parameters were obtained by adding calf circumference (SARC-CC) and mid-upper arm circumference (SARC-MUAC) measurements were added separately and together (SARC-CC-MUAC) to the SARC-F. For the calf circumference cut-off points of <31 cm and <33 cm and for the mid-upper arm circumference cut-off points of <25 cm and <31 cm were used for the sensitivity and specificity analyses.
Detailed description
The population of the research is individuals aged 65 and over who applied to Ege University Medical Faculty Hospital Internal Diseases Department, Geriatrics BD Outpatient Clinic. For statistical power analysis; When α=0.05 and the power of the study are 0.80, the minimum number of samples required for the study was determined as 190. The relevant sample size was calculated with the G-Power 3.0.8 package program.
Data collection tools:
- General information collection form: Investigator collect data about age, gender, chronic diseases, economic status, etc of participants
- Measurement of Muscle Mass, Muscle Strength, and Gait Speed Body composition analysis was determined by electrical bioimpedance using the Tanita MC-780 multi-frequency segmental Body Composition Analyzer (Tanita Corporation, Tokyo). The appendicular skeletal muscle mass (ASM) was calculated with the Janssen equation for EWGSOP criteria and Sergi equation for EWGSOP 2 criteria. The appendicular muscle mass index (ASMI) was calculated based on the equation: ASM(kg) /height (m2). Muscle strength (kg) was assessed with the Takei Grip Strength Dynamometer®. Handgrip strength (HS) measurements were made with the subjects in a sitting position, with the elbow and wrist in full extension, three times with an interval of five seconds on both hands, and the highest value among the measurement results was used for analysis. Gender-specific cut-offs were used to define low muscle strength (30 and 20 kg in males and females) for EWGSOP criteria, and (27 and 16 kg in males and females) for EWGSOP 2 criteria. Usual gait speed (m/s) was performed by the subjects walking 4 m with usual speed and ≤0.8 m/s was defined as low walking speed.
- Anthropometric measurement: In all participants, height was measured using a stadiometer to the nearest 0.1 cm, weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body mass index (BMI) was calculated by the weight (kg)/height (m2) equation. The calf circumference (CC) of participants was measured with an inflexible tape measure, in the sitting position, with the knee flexed to 90º, and the circumference of the widest part of the calf. Both the standard CC cut-off (<31 cm) and population-specific cut-off (<33 cm) were used and compared in SARC-CalF analysis. Mid upper arm circumference (MUAC) was measured in a stand position, the mid-point of the participant's left upper arm- located between the acromion and olecranon- was marked when the elbow bent to a 90o angle and measured with the inflexible tape around the marked midpoint with the participant's arm hung down naturally.
- Screening of sarcopenia risk and assessment of sarcopenia SARC-F, SARC-CalF, and SARC-MUAC were used for screening sarcopenia risk. For the SARC-F total score of ≥4, SARC-CalF ≥11, and SARC-MUAC≥11 were defined as positive sarcopenia risk. Investigator used EWGSOP and EWGSOP 2 criteria for sarcopenia diagnosis.
- Statistic analysis: SPSS 25.0 (SPSS Statistics; IBM, Armonk, NY) and MedCalc Statistical Software 19.1.6-free trial (MedCalc Software, Ostend, Belgium) statistical package programs were used for statistical analysis. The level of significance was defined as p<0.05.
For categorical variables, the data were presented as numbers (percentage). Continuous variables with normal or skewed distribution were presented as mean (standard deviation) or median (interquartile range), respectively. Group differences were investigated using the t-test for normally distributed data and the Mann-Whitney test for skewed data and the X2 or Fisher's exact test for categorical data was used. Using EWGSOP and EWGSOP 2 criteria as the reference standard, the investigator calculated the diagnostic value of the SARC-F, SARC-CalF- 31, and SARC-CalF-33 [sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy] for identifying sarcopenia. A receiver operating characteristics (ROC) curve was used to compare the overall accuracy of SARC-F, SARC-CalF-31, and SARC-CalF-33. The area under the ROC curve (AUC) and 95% confidence interval (CI) were calculated.
The exclusion criteria are as follows: an implanted pacemaker, severe mental illness, unable to walk, severe heart failure, severe renal failure, clinically visible edema, and unable to communicate.
Participants in which all the evaluations in the research protocol were carried out and answered all the questions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling participants aged 65 and over who applied to the geriatrics outpatient clinic for any reason.
Key inclusion criteria (1 listed)
- participants who applied to the geriatrics outpatient clinic for any reason
Key exclusion criteria (1 listed)
- Participants with an implanted pacemaker, severe mental illness, unable to walk, severe heart failure, severe renal failure, clinically visible edema, and unable to communicate.
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 |
|---|---|---|
| anthoropometric measurement, SARC- F questionnareSARC-F, CC, MUAC | Other | – |
Primary outcome
sarcopenia prevalance
Time frame: Day 1
number
SARC-F score
Time frame: Day 1
number
mid-upper arm circumference
Time frame: Day 1
cm
calf circumference
Time frame: Day 1
cm
Appendicular skeletal muscle mass index
Time frame: Day 1
kg/m2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 24418116Abd-El-Gawad WM, Abou-Hashem RM, El Maraghy MO, Amin GE. The validity of Geriatric Nutrition Risk Index: simple tool for prediction of nutritional-related complication of hospitalized elderly patients. Comparison with Mini Nutritional Assessment. Clin Nutr. 2014 Dec;33(6):1108-16. doi: 10.1016/j.clnu.2013.12.005. Epub 2013 Dec 28.
- Background: PubMed 31898170Ates Bulut E, Soysal P, Dokuzlar O, Kocyigit SE, Aydin AE, Yavuz I, Isik AT. Validation of population-based cutoffs for low muscle mass and strength in a population of Turkish elderly adults. Aging Clin Exp Res. 2020 Sep;32(9):1749-1755. doi: 10.1007/s40520-019-01448-4. Epub 2020 Jan 2.
- Background: PubMed 30272090Bahat G, Yilmaz O, Kilic C, Oren MM, Karan MA. Performance of SARC-F in Regard to Sarcopenia Definitions, Muscle Mass and Functional Measures. J Nutr Health Aging. 2018;22(8):898-903. doi: 10.1007/s12603-018-1067-8.
- Background: PubMed 32143888Fu X, Tian Z, Thapa S, Sun H, Wen S, Xiong H, Yu S. Comparing SARC-F with SARC-CalF for screening sarcopenia in advanced cancer patients. Clin Nutr. 2020 Nov;39(11):3337-3345. doi: 10.1016/j.clnu.2020.02.020. Epub 2020 Feb 22.
- Background: PubMed 25103151Sergi G, De Rui M, Veronese N, Bolzetta F, Berton L, Carraro S, Bano G, Coin A, Manzato E, Perissinotto E. Assessing appendicular skeletal muscle mass with bioelectrical impedance analysis in free-living Caucasian older adults. Clin Nutr. 2015 Aug;34(4):667-73. doi: 10.1016/j.clnu.2014.07.010. Epub 2014 Jul 24.
- Background: PubMed 33279661da Luz MCL, Pinho CPS, Bezerra GKA, da Conceicao Chaves de Lemos M, da Silva Diniz A, Cabral PC. SARC-F and SARC-CalF in screening for sarcopenia in older adults with Parkinson's disease. Exp Gerontol. 2021 Feb;144:111183. doi: 10.1016/j.exger.2020.111183. Epub 2020 Dec 3.
- Background: PubMed 31455509Hajaoui M, Locquet M, Beaudart C, Reginster JY, Petermans J, Bruyere O. Sarcopenia: Performance of the SARC-F Questionnaire According to the European Consensus Criteria, EWGSOP1 and EWGSOP2. J Am Med Dir Assoc. 2019 Sep;20(9):1182-1183. doi: 10.1016/j.jamda.2019.05.021. No abstract available.
- Background: PubMed 31980396Drey M, Ferrari U, Schraml M, Kemmler W, Schoene D, Franke A, Freiberger E, Kob R, Sieber C. German Version of SARC-F: Translation, Adaption, and Validation. J Am Med Dir Assoc. 2020 Jun;21(6):747-751.e1. doi: 10.1016/j.jamda.2019.12.011. Epub 2020 Jan 21.
- Individual participant dataSharing planned: Undecided
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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.
yasemin A Atik-Altinok, PhD principal investigator
Ege University
Devrim Bozkurt, Assoc Prof study director
Ege University
Sumru Savaş, Assoc Prof principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Older People, run by Ege University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 7 Mar 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sarcopenia prevalance (time frame: Day 1). The study lists 5 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 NCT05241886, which also lists 8 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 7 Mar 2022.