Doxorubicin Induced CardiomyopathyMUSCLENCT05731375
Mitochondrial dysfUnction: a Key Player in Doxorubicin-induced Skeletal and Cardiac muscLE Damage
An observational study of Doxorubicin Induced Cardiomyopathy and Chemotherapeutic Toxicity, run by UMC Utrecht at 4 sites in Netherlands.
Trial summary
The goal of this observational study is to demonstrate the ability of using non-invasive Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) to monitor changes of in-vivo markers of mitochondrial function in skeletal and cardiac muscles in muscles in patients with cancer treated with anthracyclines and/or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Doxorubicin Induced Cardiomyopathy, Chemotherapeutic Toxicity, Anthracyclines
- What is being tested?
- 31-MRS at 7 Tesla (T)
- How many people
- 12 participants
- Where
- 4 sitesNetherlands
- Study dates
- 28 Dec 2023to 20 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited at UMC Utrecht, Diakonessenhuis Utrecht and possibly other hospitals in the vincity of the UMC Utrecht. The aim is to include 12 patients with with any type of cancer scheduled to receive treatment with anthracyclines and/or platinum-based drugs at any of the recruiting hospitals.
Who may be able to join
- Age ≥ 18 years
- Patients diagnosed with any type of cancer, who are scheduled to receive chemotherapy treatment containing at least anthracyclines and/or platinum-based drugs.
- WHO-performance score 0-2.
- Patients with sufficient Dutch writing and reading skills.
- Written informed consent.
Who cannot join
- Contra-indications for 7T MR scanning, including patients with a non-MRI compatible pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; patients with a non-MR compatible aneurysm clip in their brain; patients with claustrophobia, and/or severe obesity.
- Any circumstances that would impede adherence to study requirements or ability to give informed consent.
- Medical disorders affecting mitochondrial function; e.g., spinal muscular atrophy.
- (Other) relevant medical disorders; e.g., comorbidities affecting exercise tolerance.
- Being under examination for non-diagnosed disease at the time of investigation.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Meander Medisch Centrum
Amersfoort, Utrecht, 3813 TZ
Ziekenhuis Gelderse Vallei
Ede, Gelderland, 6716 RP
Diakonessenhuis
Utrecht, Utrecht, 3582 KE
UMC Utrecht
Utrecht, Utrecht, 3584CX
About this study
The goal of this observational study is to demonstrate the ability of using non-invasive Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) to monitor changes of in-vivo markers of mitochondrial function in skeletal and cardiac muscles in muscles in patients with cancer treated with anthracyclines and/or platinum-derivates. The main question it aims to answer is:
- Can 31P-MRS be used to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles in patients with cancer undergoing treatment with anthracyclines and or platinum derivates?
To be able to answer this main question, participants will undergo 31P-MRS imaging of the calf muscles and of the heart 3 times during the study period.
Read the detailed description
Rationale: Anthracyclines and platinum-based drugs are widely used chemotherapeutic agents, offering a favorable approach to treating solid and hematological cancers. However, treatment with these drugs can lead to severe toxicities, which last for many years. These chemotherapeutic agents are known to have detrimental effects on skeletal and cardiac muscles. Loss of skeletal muscle mass is associated with treatment modifications (i.e., dose delay/reduction/discontinuation), increased levels of fatigue, decreased quality of life (QoL) and shorter survival. Cardiomyopathy might lead to chronic heart failure in the long-term, which negatively affects prognosis as well. Preclinical studies investigating underlying mechanisms of these detrimental effects suggest that mitochondrial dysfunction plays a key role. However, human data is lacking due to the need of invasive repeated muscle biopsies. Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) is an innovative, non-invasive technique, which enables repeated measures of skeletal and cardiac muscle mitochondrial energy metabolism.
Hypothesis:
In this study we hypothesize that patients treated with anthracyclines and/or platinum-based agents will show decreased mitochondrial function in skeletal and cardiac muscle tissue following chemotherapy treatment.
Objective:
To demonstrate the ability of using non-invasive 31P-MRS to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles (i.e., skeletal muscle PCr recovery rate constant and cardiac PCr/ATP ratio) in patients treated with anthracyclines and/or platinum-based agents. Furthermore, we will assess the feasibility of undergoing the study measurements for patients during intensive cancer treatment and explore the association between changes in in vivo measured mitochondrial function in skeletal and cardiac muscle tissue and changes in muscle mass, physical fitness, muscle strength, physical activity levels measured by Fitbit, chemotherapy completion rate and patient-reported outcomes, including physical activity, fatigue and quality of life.
Study design: Cohort study.
Study population: Patients scheduled for cancer treatment with anthracyclines and/or platinum-based agents.
Main study parameters/endpoints:
The main study parameters are differences in skeletal muscle PCr recovery rate constant and cardiac PCr/ATP ratio. These parameters will be compared within-patients before, halfway during and after completion of chemotherapy treatment.
Nature and extent of the burden and risks associated with participation and benefit:
Included patients will visit the UMC Utrecht 3 times (i.e., before, halfway during and after completion of chemotherapy treatment). During these visits, participants will undergo 31P-MRS imaging of the calf muscles and of the heart at 7 Tesla. During the calf muscle scan, patients will be asked to perform a mild exercise challenge (i.e., dynamic plantar flexions). 7T 31P-MRS is a safe and reliable technique for subjects without contra-indications for undergoing MRI. Possible side-effects are limited to short-term vertigo and nausea. In addition, anthropometrics will be measured and small tests to evaluate muscle strength and physical performance will be performed. Participants will be asked to complete questionnaires regarding physical activity, quality of life and fatigue. Finally, patients will be asked to wear a Fitbit, provided by the study team, to objectively assess their levels of physical activity.
Subjects will not experience direct benefits by participating in this study. By the end of the study, the investigators will demonstrate the ability to non-invasively monitor skeletal and cardiac muscle mitochondrial damage using 31P-MRS, which is a pre-requisite to assess the efficacy of (non-)pharmacological interventions.
- Being tested
- 31-MRS at 7 Tesla (T)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
31-MRS at 7 Tesla (T)Diagnostic test
31-MRS imaging at 7T to evaluate mitochondrial function in skeletal and cardiac muscles.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients scheduled for cancer treatment with anthracyclines and/or platinum-based agents. Receives: Diagnostic Test: 31-MRS at 7 Tesla (T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skeletal and cardiac muscle mitochondrial function
Assessed through 31P-MRS imaging. Parameters include:
- PCr recovery rate (in seconds)
- PCr/ATP ratio
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Secondary outcomes (12)
Adherence rates to the study protocol
Measured as:
- recruitment/retention rates
- completion of study measurements within timeframes
Measured: Baseline to 18 weeks.
Changes in physical fitness (Maximum short exercise capacity (Watt))
Assessed through Steep Ramp test
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in hand grip strength (kg)
Assessed through Hand Grip Strength Test
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in leg strength (kg)
Assessed through hypothetical 1-repetition max leg press
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in skeletal muscle area in cm2
Assessed through routine CT-scans
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in subjective physical activity levels (min/week moderate-to-vigorous physical activity)
Physical activity levels will be assessed subjectively using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH)
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in objective physical activity levels (min/week moderate-to-vigorous physical activity)
Participants are provided with a Fitbit Inspire HR and are asked to wear these as much as possible during the whole study period. The Fitbit continuously registers the heart rate. Based on this, physical activity levels will be calculated.
Measured: Throughout the whole study, but of particular interest are the 9th week after baseline and 18th week post-baseline
Changes in health-related Quality of Life
Measured using the core EORTC Quality of life questionnaire (QLQ-C30). The results of the questionnaire can be used to calculate a summary score, global health status, functional subscales and symptom subscales. For the summary score, global health status and functional subscales, a higher score is a better outcome, whilst for the symptom subscales, a lower score is a better outcome. All scores range from 0 to 100.
- Global health status
- Summary score
Functional scales:
- Physical functioning
- Role functioning
- Emotional functioning
- Cognitive functioning
- Social functioning
Symptom scales:
- Fatigue
- Nausea and vomiting
- Pain
- Dyspnoea
- Insomnia
- Appetite loss
- Constipation
- Diarrhoea
- Financial difficulties
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in lymphoma specific symptoms
Measured using the add-on of the abovementioned EORTC QLQ-C30, which is specifically developed for non-Hodgkin lymphoma patients (EORTC QLQ-NHL-HG29). A higher score depicts worse outcomes. All scores range from 0 to 100.
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in fatigue
The EORTC provides several questionnaires to asses the quality of life of cancer patients. To assess fatigue the EORTC developed a specific fatigue questionnaire (QLQ-FA12). This questionnaire can be used to assess different dimensions of fatigue. A lower score depicts a better outcome. All scores range from 0 to 100.
Fatigue dimensions:
- Physical fatigue
- Emotional fatigue
- Cognitive fatigue
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in skeletal muscle end-exercise pH
Assessed through 31P-MRS imaging.
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in skeletal muscle delta PCr during recovery after exercise in mM
Assessed through 31P-MRS imaging.
Measured: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start28 Dec 2023
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doxorubicin Induced CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Julius Clinical
- Responsible party
- Principal investigator, Dr. Anne May, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731375
- Sponsor's protocol ID
- NL83538.041
- Acronym
- MUSCLE
- Status last verified
- May 2026
- First submitted
- 25 Jan 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As the data is privacy-sensitive, the investigators will publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). In the event that peers like to reuse our data this can only be granted if the research question is in line with the original informed consent signed by the study participants. Every application therefore wille be screened for this requirement. If granted, a data usage agreement is signed by the receiving party.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial dysfUnction: a Key Player in Doxorubicin-induced Skeletal and Cardiac muscLE Damage
- ClinicalTrials.gov ID
- NCT05731375
- Acronym / sponsor ID
- MUSCLE / NL83538.041
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Julius Clinical
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 16 Feb 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 observational study is to demonstrate the ability of using non-invasive Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) to monitor changes of in-vivo markers of mitochondrial function in skeletal and cardiac muscles in muscles in patients with cancer treated with anthracyclines and/or platinum-derivates. The main question it aims to answer is:
- Can 31P-MRS be used to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles in patients with cancer undergoing treatment with anthracyclines and or platinum derivates?
To be able to answer this main question, participants will undergo 31P-MRS imaging of the calf muscles and of the heart 3 times during the study period.
Detailed description
Rationale: Anthracyclines and platinum-based drugs are widely used chemotherapeutic agents, offering a favorable approach to treating solid and hematological cancers. However, treatment with these drugs can lead to severe toxicities, which last for many years. These chemotherapeutic agents are known to have detrimental effects on skeletal and cardiac muscles. Loss of skeletal muscle mass is associated with treatment modifications (i.e., dose delay/reduction/discontinuation), increased levels of fatigue, decreased quality of life (QoL) and shorter survival. Cardiomyopathy might lead to chronic heart failure in the long-term, which negatively affects prognosis as well. Preclinical studies investigating underlying mechanisms of these detrimental effects suggest that mitochondrial dysfunction plays a key role. However, human data is lacking due to the need of invasive repeated muscle biopsies. Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) is an innovative, non-invasive technique, which enables repeated measures of skeletal and cardiac muscle mitochondrial energy metabolism.
Hypothesis:
In this study we hypothesize that patients treated with anthracyclines and/or platinum-based agents will show decreased mitochondrial function in skeletal and cardiac muscle tissue following chemotherapy treatment.
Objective:
To demonstrate the ability of using non-invasive 31P-MRS to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles (i.e., skeletal muscle PCr recovery rate constant and cardiac PCr/ATP ratio) in patients treated with anthracyclines and/or platinum-based agents. Furthermore, we will assess the feasibility of undergoing the study measurements for patients during intensive cancer treatment and explore the association between changes in in vivo measured mitochondrial function in skeletal and cardiac muscle tissue and changes in muscle mass, physical fitness, muscle strength, physical activity levels measured by Fitbit, chemotherapy completion rate and patient-reported outcomes, including physical activity, fatigue and quality of life.
Study design: Cohort study.
Study population: Patients scheduled for cancer treatment with anthracyclines and/or platinum-based agents.
Main study parameters/endpoints:
The main study parameters are differences in skeletal muscle PCr recovery rate constant and cardiac PCr/ATP ratio. These parameters will be compared within-patients before, halfway during and after completion of chemotherapy treatment.
Nature and extent of the burden and risks associated with participation and benefit:
Included patients will visit the UMC Utrecht 3 times (i.e., before, halfway during and after completion of chemotherapy treatment). During these visits, participants will undergo 31P-MRS imaging of the calf muscles and of the heart at 7 Tesla. During the calf muscle scan, patients will be asked to perform a mild exercise challenge (i.e., dynamic plantar flexions). 7T 31P-MRS is a safe and reliable technique for subjects without contra-indications for undergoing MRI. Possible side-effects are limited to short-term vertigo and nausea. In addition, anthropometrics will be measured and small tests to evaluate muscle strength and physical performance will be performed. Participants will be asked to complete questionnaires regarding physical activity, quality of life and fatigue. Finally, patients will be asked to wear a Fitbit, provided by the study team, to objectively assess their levels of physical activity.
Subjects will not experience direct benefits by participating in this study. By the end of the study, the investigators will demonstrate the ability to non-invasively monitor skeletal and cardiac muscle mitochondrial damage using 31P-MRS, which is a pre-requisite to assess the efficacy of (non-)pharmacological interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Diagnostic Test: 31-MRS at 7 Tesla (T)Patients scheduled for cancer treatment with anthracyclines and/or platinum-based agents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at UMC Utrecht, Diakonessenhuis Utrecht and possibly other hospitals in the vincity of the UMC Utrecht. The aim is to include 12 patients with with any type of cancer scheduled to receive treatment with anthracyclines and/or platinum-based drugs at any of the recruiting hospitals.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patients diagnosed with any type of cancer, who are scheduled to receive chemotherapy treatment containing at least anthracyclines and/or platinum-based drugs.
- WHO-performance score 0-2.
- Patients with sufficient Dutch writing and reading skills.
- Written informed consent.
Key exclusion criteria (5 listed)
- Contra-indications for 7T MR scanning, including patients with a non-MRI compatible pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; patients with a non-MR compatible aneurysm clip in their brain; patients with claustrophobia, and/or severe obesity.
- Any circumstances that would impede adherence to study requirements or ability to give informed consent.
- Medical disorders affecting mitochondrial function; e.g., spinal muscular atrophy.
- (Other) relevant medical disorders; e.g., comorbidities affecting exercise tolerance.
- Being under examination for non-diagnosed disease at the time of investigation.
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 |
|---|---|---|
| 31-MRS at 7 Tesla (T)31-MRS imaging at 7T to evaluate mitochondrial function in skeletal and cardiac muscles. | Diagnostic test | Study population |
Primary outcome
Changes in skeletal and cardiac muscle mitochondrial function
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Assessed through 31P-MRS imaging. Parameters include: * PCr recovery rate (in seconds) * PCr/ATP ratio
12 secondary outcomes
Adherence rates to the study protocol
Time frame: Baseline to 18 weeks.
Changes in physical fitness (Maximum short exercise capacity (Watt))
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in hand grip strength (kg)
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in leg strength (kg)
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in skeletal muscle area in cm2
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in subjective physical activity levels (min/week moderate-to-vigorous physical activity)
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in objective physical activity levels (min/week moderate-to-vigorous physical activity)
Time frame: Throughout the whole study, but of particular interest are the 9th week after baseline and 18th week post-baseline
Changes in health-related Quality of Life
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in lymphoma specific symptoms
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in fatigue
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in skeletal muscle end-exercise pH
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
Changes in skeletal muscle delta PCr during recovery after exercise in mM
Time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)
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 11 May 2026.
- Individual participant dataSharing planned: Yes. As the data is privacy-sensitive, the investigators will publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). In the event that peers like to reuse our data this can only be granted if the research question is in line with the original informed consent signed by the study participants. Every application therefore wille be screened for this requirement. If granted, a data usage agreement is signed by the receiving party.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Doxorubicin Induced Cardiomyopathy and Chemotherapeutic Toxicity, run by UMC Utrecht at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
Changes in skeletal and cardiac muscle mitochondrial function (time frame: Baseline, halfway (R-)CHOP treatment (+/- 9 weeks), after (R-)CHOP treatment (+/- 18 weeks)). 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 11 May 2026.