Adapted Physical ActivityAPAER_HNCT05475600
APA and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in ICU
A study testing Classical APA group:, APA with Exergaming device and APA associated with biofeedback relaxation in people with Adapted Physical Activity and Hematological Malignancies, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Adapted Physical Activity (APA) is accepted as an effective, recommended and beneficial supportive care for the health of people with cancer during the different phases of the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adapted Physical Activity, Hematological Malignancies, Anxiety
- What is being tested?
- Classical APA group:, APA with Exergaming device and APA associated with biofeedback relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18 and 75 years old
- Admitted in Intensive Care Unit
- Informed consent
Who cannot join
- Contraindication for physical exercise
- Inability to understand the French language (written and/or oral)
- Ongoing involvement in another proprietary research protocol
- Lack of affiliation to social security
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville/Hopital de Mercy
Metz, 57085
Arpiné EL NAR, PhD, 0033387557766, a.elnar@chr-metz-thionville.fr
About this study
Official title: Adapted Physical Activity and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in Intensive Care unit_APAER_H Protocol
Adapted Physical Activity (APA) is accepted as an effective, recommended and beneficial supportive care for the health of people with cancer during the different phases of the disease. The objective of the project is to analyse the effect of APA programs (Classic, Exergaming and Relaxation) on the state anxiety of people with severe blood diseases admitted to Intensive Care Unit (ICU). Anxiety is a major affect in this context. The interest of the practice of APA for this public is to reduce the level of state anxiety and to limit the decline of functional capacities. The main objective of this work is to identify whether specific and/or complementary effects result from the use of biofeedback and/or Exergaming.
Read the detailed description
Haematological malignancies have several unpleasant consequences on psychological and physical health. Indeed, an important fatigue and reduction of functional capacities appear. Reduction of functional capacities leads to the reduction of autonomy in Acts of Daily Living (ADL) and impact negatively the global Quality of Life (GQoL). Patients who undergo high dose treatment in protected area have higher risks of functional decline. In addition, hospital stay alone in sterile room favours increase of anxiety and depression.
Health care strategies are going to integrate and use more of support care as APA and relaxation. Regular APA practice leads to maintain and/or improve physical functioning and psychological well-being. Physical Activity ensures to maintain or develop muscular strength and cardio-respiratory capacities that patients loose if they stay inactive during hospital stay. APA practice participates too in regulation of emotional states. Indeed, it favours positive emotions as self-esteem, self-confidence, satisfaction and pleasure. In the order to limit or reduce anxiety level, relaxation provides an effective response. Maintain functional capacities and reduce negatives emotional states participate to reduce fatigue too. Also, APA associated with relaxation seems to be a good effective support care strategy.
The aim of this study is to implement a supervised APA program with entertaining devices as Exergaming and Biofeedback relaxation for patients undergo high dose treatment in protected area.
Exergaming consists on exercise and training through fun or recreative situations.
Biofeedback device is a relaxation tool that gives feedback on functioning of nervous system in real time. The objective is to leads patients to become aware of their body-information to finally, associate them to sensations and more effectively control them.
The objectives of this study are to:
- To reduce state anxiety level and psychological fatigue impact on GQoL and
- To Maintain or improve functional capacities and reduce physical fatigue.
The main hypotheses are:
- Each of the three programs leads to the objectives specified above.
- APA associated with biofeedback relaxation reduce more state anxiety level than APA with Exergaming that is more effective than APA classic.
- APA with Exergaming and biofeedback practice gender more satisfaction and adhesion than APA classic
The program takes place 3 times per week. Each session lasts between 30 and 60 min. Intensity of effort is defined as light to moderate. Participants are assigned to one of the tree groups: 1-APA classic / 2-APA with Exergaming / 3-APA and Biofeedback relaxation. Aerobic activity is performed on a cyclo-ergometer (Groups 1 and 3) classic or exergaming (group 2). At the end of session, patients in relaxation group (Group 3) realise relaxation as recovery whereas other groups rest and stretch.
Functional capacities are assessed twice by submaximal tests: at the beginning and directly after APA program, just before hospital discharge. The first session affords to estimate subjects capacities and to create and individualised and adapted programme. The second affords to compare groups themselves and each other. Cardio-respiratory capacity is evaluated by the 2min Walk Test (2WT) and lower limbs muscular strength by the 5 Times Sit to Stand Test (FTSST). State anxiety level and fatigue are assessed by State and Trait Anxiety Inventory-YA (STAI-YA) and Multi-Fatigue Inventory_20items (MFI-20) respectively. At the inclusion, we complete the profile of individuals with the Hospital Anxiety and Depression Scale (HADS).
Adhesion and satisfaction are assessed by feedbacks of participants and by the comparison of the number of planned versus performed sessions.
- Being tested
- Classical APA group:, APA with Exergaming device, APA associated with biofeedback relaxation
- Medical subject headings
- Hematologic Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical APA group:Behavioural
Activity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20min / stretching / Objective: to bring the body back to a resting state
APA with Exergaming deviceBehavioural
Activity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20min / stretching / Objective: to bring the body back to a resting state
APA associated with biofeedback relaxationBehavioural
Activity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à Exergaming device 3 - Cool down: 20min / Biofeedback relaxation device / Objective: to bring the body back to a resting state
| Study group | Role | What they receive |
|---|---|---|
| Classical APA group | Experimental | Activity type: aerobic Frequency: 3 sessions per week Duration of session: 30 to 60 min Intensity: mild to moderate (4-6 on Rated Perceived Exertion (RPE) Scale) Session description: 1 - Warm-up 5 to 10 min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30 min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20 min / stretching / Objective: to bring the body back to a resting state Receives: Behavioral: Classical APA group: |
| APA with Exergaming device | Experimental | Activity type: aerobic Frequency: 3 sessions per week Duration of session: 30 to 60 min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10 min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30 min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20 min / stretching / Objective: to bring the body back to a resting state Receives: Behavioral: APA with Exergaming device |
| APA associated with biofeedback relaxation | Experimental | Activity type: aerobic Frequency: 3 sessions per week Duration of session: 30 to 60 min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10 min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30 min physical activity with an Exergaming device 3 - Cool down: 20 min / Biofeedback relaxation device / Objective: to bring the body back to a resting state Receives: Behavioral: APA associated with biofeedback relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety by the State Trait Anxiety Inventory - YA Version
Self-reported questionnaire with 20 items assessed on a 4 points scale
Measured: 2 moments: at the beginning and directly at the end of program.
Secondary outcomes (6)
Hospital Anxiety and Depression Scale
14 items Questionnaire to detect anxiety and depressive disorders
Measured: Once at the inclusion
2min Walk Test (2MWT)
sub-maximal test to assess functional capacity
Measured: : twice: at the beginning of the study and at the end: immediately after the APA program
Sit to Stand Test (SST)
Sub-maximal test to assess muscular strength
Measured: twice: at the beginning of the study and at the end: immediately after the APA program
Multi-Fatigue Inventory_20 items (MFI-20)
20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.
Measured: Twice: at the beginning of the study and at the end: just before hospital discharge.
EORTC quality of life questionnaire quality of life questionnaire (QLQ)-C30
Questionnaire developed to assess the quality of life of cancer patients
Measured: Twice: At the beginning of the study and one month after the intervention
Evaluation of the acute effect of an adapted physical activity session on the change in state Anxiety by the State Trait Anxiety Inventory - YA Version
Self-reported questionnaire with 20 items assessed on a 4 points scale
Measured: Twice at each moment: just before the session and directly after it to obtain the acute effect of the APA Session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start2 Dec 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adapted Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Sponsor
- Investigators
- Véronique DORVAUX, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475600
- Sponsor's protocol ID
- 2022-01-CHRMT
- Acronym
- APAER_H
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bousmia J, Langlet C, Elnar AA, Goetz C, Bolmont B, Dorvaux V. Adapted physical activity, exergaming and relaxation by biofeedback in haematological intensive care unit in France: study protocol of a randomised controlled trial (APAER-H trial). BMJ Open. 2025 Dec 4;15(12):e099876. doi: 10.1136/bmjopen-2025-099876.
PubMed 41344711
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in Intensive Care unit_APAER_H Protocol
- ClinicalTrials.gov ID
- NCT05475600
- Acronym / sponsor ID
- APAER_H / 2022-01-CHRMT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jul 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.
Adapted Physical Activity (APA) is accepted as an effective, recommended and beneficial supportive care for the health of people with cancer during the different phases of the disease. The objective of the project is to analyse the effect of APA programs (Classic, Exergaming and Relaxation) on the state anxiety of people with severe blood diseases admitted to Intensive Care Unit (ICU). Anxiety is a major affect in this context. The interest of the practice of APA for this public is to reduce the level of state anxiety and to limit the decline of functional capacities. The main objective of this work is to identify whether specific and/or complementary effects result from the use of biofeedback and/or Exergaming.
Detailed description
Haematological malignancies have several unpleasant consequences on psychological and physical health. Indeed, an important fatigue and reduction of functional capacities appear. Reduction of functional capacities leads to the reduction of autonomy in Acts of Daily Living (ADL) and impact negatively the global Quality of Life (GQoL). Patients who undergo high dose treatment in protected area have higher risks of functional decline. In addition, hospital stay alone in sterile room favours increase of anxiety and depression.
Health care strategies are going to integrate and use more of support care as APA and relaxation. Regular APA practice leads to maintain and/or improve physical functioning and psychological well-being. Physical Activity ensures to maintain or develop muscular strength and cardio-respiratory capacities that patients loose if they stay inactive during hospital stay. APA practice participates too in regulation of emotional states. Indeed, it favours positive emotions as self-esteem, self-confidence, satisfaction and pleasure. In the order to limit or reduce anxiety level, relaxation provides an effective response. Maintain functional capacities and reduce negatives emotional states participate to reduce fatigue too. Also, APA associated with relaxation seems to be a good effective support care strategy.
The aim of this study is to implement a supervised APA program with entertaining devices as Exergaming and Biofeedback relaxation for patients undergo high dose treatment in protected area.
Exergaming consists on exercise and training through fun or recreative situations.
Biofeedback device is a relaxation tool that gives feedback on functioning of nervous system in real time. The objective is to leads patients to become aware of their body-information to finally, associate them to sensations and more effectively control them.
The objectives of this study are to:
- To reduce state anxiety level and psychological fatigue impact on GQoL and
- To Maintain or improve functional capacities and reduce physical fatigue.
The main hypotheses are:
- Each of the three programs leads to the objectives specified above.
- APA associated with biofeedback relaxation reduce more state anxiety level than APA with Exergaming that is more effective than APA classic.
- APA with Exergaming and biofeedback practice gender more satisfaction and adhesion than APA classic
The program takes place 3 times per week. Each session lasts between 30 and 60 min. Intensity of effort is defined as light to moderate. Participants are assigned to one of the tree groups: 1-APA classic / 2-APA with Exergaming / 3-APA and Biofeedback relaxation. Aerobic activity is performed on a cyclo-ergometer (Groups 1 and 3) classic or exergaming (group 2). At the end of session, patients in relaxation group (Group 3) realise relaxation as recovery whereas other groups rest and stretch.
Functional capacities are assessed twice by submaximal tests: at the beginning and directly after APA program, just before hospital discharge. The first session affords to estimate subjects capacities and to create and individualised and adapted programme. The second affords to compare groups themselves and each other. Cardio-respiratory capacity is evaluated by the 2min Walk Test (2WT) and lower limbs muscular strength by the 5 Times Sit to Stand Test (FTSST). State anxiety level and fatigue are assessed by State and Trait Anxiety Inventory-YA (STAI-YA) and Multi-Fatigue Inventory_20items (MFI-20) respectively. At the inclusion, we complete the profile of individuals with the Hospital Anxiety and Depression Scale (HADS).
Adhesion and satisfaction are assessed by feedbacks of participants and by the comparison of the number of planned versus performed sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classical APA group | Experimental | Behavioral: Classical APA group:Activity type: aerobic Frequency: 3 sessions per week Duration of session: 30 to 60 min Intensity: mild to moderate (4-6 on Rated Perceived Exertion (RPE) Scale) Session description: 1 - Warm-up 5 to 10 min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30 min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20 min / stretching / Objective: to bring the body back to a resting state |
| APA with Exergaming device | Experimental | Behavioral: APA with Exergaming deviceActivity type: aerobic Frequency: 3 sessions per week Duration of session: 30 to 60 min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10 min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30 min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20 min / stretching / Objective: to bring the body back to a resting state |
| APA associated with biofeedback relaxation | Experimental | Behavioral: APA associated with biofeedback relaxationActivity type: aerobic Frequency: 3 sessions per week Duration of session: 30 to 60 min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10 min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30 min physical activity with an Exergaming device 3 - Cool down: 20 min / Biofeedback relaxation device / Objective: to bring the body back to a resting state |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged between 18 and 75 years old
- Admitted in Intensive Care Unit
- Informed consent
Key exclusion criteria (4 listed)
- Contraindication for physical exercise
- Inability to understand the French language (written and/or oral)
- Ongoing involvement in another proprietary research protocol
- Lack of affiliation to social security
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 |
|---|---|---|
| Classical APA group:Activity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20min / stretching / Objective: to bring the body back to a resting state | Behavioural | Classical APA group |
| APA with Exergaming deviceActivity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20min / stretching / Objective: to bring the body back to a resting state | Behavioural | APA with Exergaming device |
| APA associated with biofeedback relaxationActivity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à Exergaming device 3 - Cool down: 20min / Biofeedback relaxation device / Objective: to bring the body back to a resting state | Behavioural | APA associated with biofeedback relaxation |
Primary outcome
Change in State Anxiety by the State Trait Anxiety Inventory - YA Version
Time frame: 2 moments: at the beginning and directly at the end of program.
Self-reported questionnaire with 20 items assessed on a 4 points scale
6 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Once at the inclusion
2min Walk Test (2MWT)
Time frame: : twice: at the beginning of the study and at the end: immediately after the APA program
Sit to Stand Test (SST)
Time frame: twice: at the beginning of the study and at the end: immediately after the APA program
Multi-Fatigue Inventory_20 items (MFI-20)
Time frame: Twice: at the beginning of the study and at the end: just before hospital discharge.
EORTC quality of life questionnaire quality of life questionnaire (QLQ)-C30
Time frame: Twice: At the beginning of the study and one month after the intervention
Evaluation of the acute effect of an adapted physical activity session on the change in state Anxiety by the State Trait Anxiety Inventory - YA Version
Time frame: Twice at each moment: just before the session and directly after it to obtain the acute effect of the APA Session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 41344711Bousmia J, Langlet C, Elnar AA, Goetz C, Bolmont B, Dorvaux V. Adapted physical activity, exergaming and relaxation by biofeedback in haematological intensive care unit in France: study protocol of a randomised controlled trial (APAER-H trial). BMJ Open. 2025 Dec 4;15(12):e099876. doi: 10.1136/bmjopen-2025-099876.
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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.
Véronique DORVAUX, MD principal investigator
CHR Metz Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical APA group:, APA with Exergaming device and APA associated with biofeedback relaxation in people with Adapted Physical Activity and Hematological Malignancies, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arpiné EL NAR, PhD (0033387557766, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety by the State Trait Anxiety Inventory - YA Version (time frame: 2 moments: at the beginning and directly at the end of program.). 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 NCT05475600, which also lists 1 linked publication.
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 17 Mar 2025.