Breast Cancer SurvivorsBRAINonFITNCT06073717
Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).
A study testing Exercise, Motor-cognitive Training and Health and Wellness in people with Breast Cancer Survivors and Cognitive Impairment, run by University of Seville at 3 sites in Spain.
Trial summary
The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Breast Cancer Survivors, Cognitive Impairment, Executive Dysfunction
- What is being tested?
- Exercise, Motor-cognitive Training and Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Oct 2024to Dec 2026
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with stage I-IIIA breast cancer
- Completed primary treatment, including surgery, radiotherapy and/or chemotherapy
- Scheduled to receive adjuvant endocrine therapy, or currently receiving adjuvant endocrine therapy
- Without functional limitations or other illnesses that condition and prevent them from practising intense physical exercise
- FACT-Cog questionnaire score ≥ 10th percentile considering age groups
- Fluency in Spanish (spoken and written)
Who cannot join
- Undergoing radiotherapy and/or chemotherapy
- FACT-Cog questionnaire score ≤ 10th percentile considering age groups
- Congenital heart disease
- Chronic lung disease
- Severe psychiatric disorders
- History of substance abuse, or dependence (other than tobacco)
- Mood disorders require treatment (anxiety or depression)
- Relapses (2-3 months before the study start)
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
SADUS - Servicio de Actividades Deportivas de la Universidad de Sevilla
Seville, Sevilla, 41012
Laboratorio de Ciencias del Deporte
Seville, Sevilla, 41013
Oncoavanze
Seville, Sevilla, 41013
About this study
Official title: Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study
The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are:
- Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants.
- Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk.
Read more
Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges.
Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk.
Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).
- Being tested
- Exercise, Motor-cognitive Training, Health and Wellness
- Keywords
- Cancer-related Cognitive Impairment, Physical exercise, dual motor-cognitive tasks, cognitive stimulation, Neurocognitive disorders
- Medical subject headings
- Cognitive Dysfunction, Motor Activity, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will complete a 5-month exercise program structured in 4 blocks of 5 weeks. Three supervised and combined aerobic/strength exercise sessions each week will be performed together with an aerobic weekly challenge. Aerobic exercise will be performed for 20-30 minutes using a treadmill, bicycle, or circuit training at light to moderate intensities (40-75% of heart rate reserve) during the first two blocks; gradually achieving high intensity (>75% of HHR) in the last two blocks. Heart rate and the subjective perception of the exertion scale (6-20 Borg scale) will be monitored. Strength exercises will be started at light to moderate intensities (2 sets of 15-20 repetitions at 40-50% of repetition maximum), performed muscle actions at high intensities in the last two blocks (2 sets of 8-15 repetitions at 50-75% RM); using elastic bands, free weights, and weights gym exercises.
Motor-cognitive TrainingBehavioural
Participants will complete the same four-block exercise program in terms of type, frequency, intensity, and volume of physical/motor training. Simultaneous with the progression of physical/motor training, the complexity of cognitive stimulation will be increased according to the performance of the participants. General dual-task training will be performed, which describes the use of a physical/motor intervention with different cognitive stimulations (memory, language, intelligence, attention, processing speed, calculation, inhibitory control) that are not specific to the methods to be used for their assessment.
Health and WellnessBehavioural
Participants randomly assigned to the health and wellness group will be advised and re-educated to support and improve health aspects. Participants in this group will aim to achieve the physical activity recommendations, and in addition, they will receive bi-weekly emails and phone call coaching with tools to empower patients with knowledge about physical exercise, nutrition, and brain health guidelines. Following completion of the 5-month exercise program, this group will receive an exercise program for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | This arm will receive a 5-month (20 weeks) supervised exercise program based on aerobic and resistance/strength training together with a weekly calorie or step challenge. Receives: Behavioral: Exercise |
| Dual Motor-Cognitive Intervention | Experimental | This arm will receive a 5-month (20 weeks) supervised and simultaneous dual-task program based on aerobic, resistance, and cognitive stimulation training together with a weekly calorie or step challenge Receives: Behavioral: Motor-cognitive Training |
| Health and Wellness Intervention | Active comparator | This arm will receive a 5-month health and wellness program. Receives: Behavioral: Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function (Cognitive Flexibility and Processing Speed)
Trail Making Test A and B (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary outcomes (16)
Inhibitory Control and Concentration
Stroop Color and Word test (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Verbal Intelligence, Non-verbal Intelligence, Verbal memory, and Non-verbal Memory
Reynolds Intellectual Assessment Scale (Global index values range from ≤ 69 to ≥ 130, mean value of 100; higher scores mean better results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Learning Ability
Wechsler Memory Scale subtest "word pairs" (The subtest score range from 40 to 60, mean value of 100; higher scores mean better results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Perceived Cognitive Functions
Functional Assessment of Cancer Therapy: Cognition (FACT-Cog) (Total score ranges from 0 to 148; higher scores mean better results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Max. Oxygen Consumption
Modified Bruce Test (80% sub-max)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Muscular Strength of shoulder and knee extensors
Isokinetic dynamometer
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Range of Movement
Manual Goniometer
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV)
Spirometry (FEV/FVC ratio, represented in percentages)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Volume of physical activity
Accelerometer (Volume in minutes per week)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Intensity of Physical Activity
Accelerometer (Intensity in metabolic equivalents)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Weight and Height
Body Mass Index (weight and height will be combined to report BMI in kg/m^2)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Brain-Derived Neurotrophic Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor 17 (FDF-17), Soluble Klotho (S-KL)
Concentration of these proteins in plasma by ELISA kit (Concentration of these proteins will be expressed in pg/mL or ng/mL)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Fatigue
Functional Assessment of Chronic Illness Therapy: Fatigue (FACIT-F) (Total score range from 0 to 52; higher scores mean better results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Pain Scale
Visual Analogue Scale (Total score ranges from 0 to 10; higher scores mean worse results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Depression
Back Depression Inventory (Total score ranges from 0 to 63; higher scores mean worse results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Anxiety
State-Trait Anxiety Inventory (The score ranges from 20 to 80; higher scores mean worse results)
Measured: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies 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
- Model description
- This study has been designed as a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Orellana Jaen, University of Seville
- Investigators
- Matilde Mora Fernández, PhD, Study director, University of SevilleLuis Carrasco Páez, PhD, Study director, University of SevilleJesús Orellana Jaén, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073717
- Sponsor's protocol ID
- 0570-N-23
- Acronym
- BRAINonFIT
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jesus OJ, Luis CP, Matilde MF. Effects of exercise on cancer-related cognitive impairment in breast cancer survivors: a scoping review. Breast Cancer. 2023 Nov;30(6):885-909. doi: 10.1007/s12282-023-01484-z. Epub 2023 Jul 22.
PubMed 37480454Orellana-Jaen J, Mora-Fernandez M, Carrasco-Paez L. Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol. Contemp Clin Trials. 2024 Nov;146:107672. doi: 10.1016/j.cct.2024.107672. Epub 2024 Sep 10.
PubMed 39265784
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study
- ClinicalTrials.gov ID
- NCT06073717
- Acronym / sponsor ID
- BRAINonFIT / 0570-N-23
- Keywords
- Cancer-related Cognitive Impairment, Physical exercise, dual motor-cognitive tasks, cognitive stimulation, Neurocognitive disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Oct 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 interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are:
- Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants.
- Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk.
Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges.
Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk.
Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study has been designed as a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks).
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: ExerciseThis arm will receive a 5-month (20 weeks) supervised exercise program based on aerobic and resistance/strength training together with a weekly calorie or step challenge. |
| Dual Motor-Cognitive Intervention | Experimental | Behavioral: Motor-cognitive TrainingThis arm will receive a 5-month (20 weeks) supervised and simultaneous dual-task program based on aerobic, resistance, and cognitive stimulation training together with a weekly calorie or step challenge |
| Health and Wellness Intervention | Active comparator | Behavioral: Health and WellnessThis arm will receive a 5-month health and wellness program. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with stage I-IIIA breast cancer
- Completed primary treatment, including surgery, radiotherapy and/or chemotherapy
- Scheduled to receive adjuvant endocrine therapy, or currently receiving adjuvant endocrine therapy
- Without functional limitations or other illnesses that condition and prevent them from practising intense physical exercise
- FACT-Cog questionnaire score ≥ 10th percentile considering age groups
Key exclusion criteria (8 listed)
- Undergoing radiotherapy and/or chemotherapy
- FACT-Cog questionnaire score ≤ 10th percentile considering age groups
- Congenital heart disease
- Chronic lung disease
- Severe psychiatric disorders
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 |
|---|---|---|
| ExerciseParticipants will complete a 5-month exercise program structured in 4 blocks of 5 weeks. Three supervised and combined aerobic/strength exercise sessions each week will be performed together with an aerobic weekly challenge. Aerobic exercise will be performed for 20-30 minutes using a treadmill, bicycle, or circuit training at light to moderate intensities (40-75% of heart rate reserve) during the first two blocks; gradually achieving high intensity (>75% of HHR) in the last two blocks. Heart rate and the subjective perception of the exertion scale (6-20 Borg scale) will be monitored. Strength exercises will be started at light to moderate intensities (2 sets of 15-20 repetitions at 40-50% of repetition maximum), performed muscle actions at high intensities in the last two blocks (2 sets of 8-15 repetitions at 50-75% RM); using elastic bands, free weights, and weights gym exercises. | Behavioural | Exercise Intervention |
| Motor-cognitive TrainingParticipants will complete the same four-block exercise program in terms of type, frequency, intensity, and volume of physical/motor training. Simultaneous with the progression of physical/motor training, the complexity of cognitive stimulation will be increased according to the performance of the participants. General dual-task training will be performed, which describes the use of a physical/motor intervention with different cognitive stimulations (memory, language, intelligence, attention, processing speed, calculation, inhibitory control) that are not specific to the methods to be used for their assessment. | Behavioural | Dual Motor-Cognitive Intervention |
| Health and WellnessParticipants randomly assigned to the health and wellness group will be advised and re-educated to support and improve health aspects. Participants in this group will aim to achieve the physical activity recommendations, and in addition, they will receive bi-weekly emails and phone call coaching with tools to empower patients with knowledge about physical exercise, nutrition, and brain health guidelines. Following completion of the 5-month exercise program, this group will receive an exercise program for 12 weeks. | Behavioural | Health and Wellness Intervention |
Primary outcome
Executive Function (Cognitive Flexibility and Processing Speed)
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Trail Making Test A and B (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)
16 secondary outcomes
Inhibitory Control and Concentration
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Verbal Intelligence, Non-verbal Intelligence, Verbal memory, and Non-verbal Memory
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Learning Ability
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Perceived Cognitive Functions
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Max. Oxygen Consumption
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Muscular Strength of shoulder and knee extensors
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Range of Movement
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV)
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Volume of physical activity
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Intensity of Physical Activity
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Weight and Height
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Brain-Derived Neurotrophic Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor 17 (FDF-17), Soluble Klotho (S-KL)
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Fatigue
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Pain Scale
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Depression
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Anxiety
Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
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 4 May 2026.
- Background: PubMed 37480454Jesus OJ, Luis CP, Matilde MF. Effects of exercise on cancer-related cognitive impairment in breast cancer survivors: a scoping review. Breast Cancer. 2023 Nov;30(6):885-909. doi: 10.1007/s12282-023-01484-z. Epub 2023 Jul 22.
- Derived from this study: PubMed 39265784Orellana-Jaen J, Mora-Fernandez M, Carrasco-Paez L. Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol. Contemp Clin Trials. 2024 Nov;146:107672. doi: 10.1016/j.cct.2024.107672. Epub 2024 Sep 10.
- Individual participant dataSharing planned: No
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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.
Matilde Mora Fernández, PhD study director
University of Seville
Luis Carrasco Páez, PhD study director
University of Seville
Jesús Orellana Jaén principal investigator
University of Seville
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Motor-cognitive Training and Health and Wellness in people with Breast Cancer Survivors and Cognitive Impairment, run by University of Seville at 3 sites in Spain.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 4 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 3 sites in Spain. 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?
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?
Executive Function (Cognitive Flexibility and Processing Speed) (time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)). 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 NCT06073717, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.