OncologyPRIMERNCT07680556
Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma
A study testing HIIT in people with Oncology, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The primary aim of this study is to evaluate the feasibility of a supervised high intensity interval training (HIIT) program during first-line dual immune checkpoint inhibitor (ICI) therapy (nivolumab plus ipilimumab) in patients with advanced renal cell carcinoma (RCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- HIIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 Jul 2026to 1 Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosed with advanced RCC with indication for standard-of-care dual ICI treatment.
- Able and willing to give written informed consent.
Who cannot join
- Life expectancy <6 months.
- Unable to perform basic activities of daily living such as walking.
- Presence of cognitive impairment or severe emotional instability (e.g. schizophrenia, Alzheimer's disease, alcohol addiction), at the discretion of the investigator.
- Presence of other disabling comorbidities that may interfere with the ability to perform physical exercise (e.g., heart failure, chronic obstructive pulmonary disease (COPD, GOLD stage 3 or 4), orthopaedic conditions, or neurological disorders such as hernia, paresis, amputation or active rheumatoid arthritis), at the discretion of the investigator.
- Current participation in structured vigorous aerobic and/or resistance exercise ≥ 2 times per week at a level comparable to the intervention
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Rijnstate
Arnhem, Gelderland
- Recruiting
Radboudumc
Nijmegen, Gelderland
Laurien M Buffart, PhD, +31 24 3667310, laurien.buffart@radboudumc.nl
About this study
The primary aim of this study is to evaluate the feasibility of a supervised high intensity interval training (HIIT) program during first-line dual immune checkpoint inhibitor (ICI) therapy (nivolumab plus ipilimumab) in patients with advanced renal cell carcinoma (RCC). The second aim is to generate preliminary data on the effects of exercise on the immune cell phenotype and function, gut microbiota composition, physical fitness, patient-reported outcomes and clinical outcomes.
This is a two-arm randomized controlled pilot trial in which 30 patients with advanced RCC scheduled to receive first-line nivolumab plus ipilimumab will be randomized in 1:1 ratio to an exercise intervention group or usual care group. The exercise intervention consists of two 60-minute supervised HIIT sessions per week, delivered by oncology-trained physiotherapists and one additional home-based moderate-intensity aerobic exercise sessions per week. The intervention starts with the first cycle of immunotherapy and continues for four treatment cycles. Participants in both groups will receive usual care and general exercise guidelines. Measurements include blood and stool sampling for microbiome and immune parameters analysis, physical fitness assessments, physical fitness monitoring, body composition measurements, and patient-reported outcomes related to quality of life, fatigue, depression, sleep and diet.
Read the detailed description
There is strong evidence from randomized controlled trials that exercise during cancer treatment can maintain physical fitness, limit fatigue, and enhance health-related quality of life (HRQoL). Some studies also showed that exercise may help patients to better tolerate their treatment. However, most exercise trials have been conducted in patients receiving chemotherapy or radiotherapy, and little is known about the feasibility or effects of exercise during immunotherapy, particularly in patients with advanced RCC.
First-line treatment for patients with advanced RCC often consists of dual ICI treatment with nivolumab plus ipilimumab. While this combination has shown to improve survival, a substantial proportion of patients do not respond, and approximately 44% experience any grade immune-related adverse events. Tumor hypoxia, an immunosuppressive tumor microenvironment, and insufficient infiltration of cytotoxic immune cells are key factors believed to contribute to treatment resistance.
Preclinical studies in mice have shown that aerobic exercise can positively influence the tumor microenvironment through reduced tumor hypoxia, enhanced tumor perfusion, and increased activity and infiltration of cytotoxic immune cells such as CD8+ T cells and natural killer (NK) cells, while reducing immunosuppressive cell populations. In addition, preclinical studies in mice suggested that exercise-induced changes in the gut microbiome can further support immune activation and improve responses to immunotherapy. Despite this promising biological rationale, no clinical studies have evaluated whether supervised exercise is feasible or beneficial in patients with advanced RCC.
The primary objective of this pilot randomized controlled trial is to evaluate the feasibility of a supervised exercise program during first-line dual ICI therapy in patients with advanced RCC. Secondary objectives are to explore the preliminary effects of exercise on immune phenotype and function, inflammatory markers, circulating tumor (ct)DNA, gut microbiome composition, body composition, aerobic fitness, muscle function, physical activity, and patient reported outcomes including HRQoL, fatigue, anxiety, depression, sleep, and diet. In addition, changes in immune function, gut microbiome composition and clinical outcomes will also be explored.
This study is a two-arm randomized controlled trial including 30 adult patients with advanced RCC. Participants will be randomized to the intervention arm that receives a supervised HIIT program in addition to usual care or to a usual care control arm. The intervention consists of two supervised 60-minute HIIT-exercise sessions per week, delivered by oncology trained physiotherapists, combined with one additional home-based moderate intensity exercise session of at least 30 min per week. The intervention starts with the first cycle of immunotherapy and continues for four treatment cycles. Blood and stool samples will be collected at baseline and at 6 weeks and 12 weeks during treatment to assess immune and microbiome changes. In addition, in participants allocated to the exercise intervention group, to evaluate the acute effects of exercise on the immune response, blood samples will be collected immediately before and after a supervised exercise session.
Physical fitness tests, questionnaires and Fitbit to monitor physical activity will be used to evaluate functional and patient-reported outcomes.
This pilot study will provide important information on the feasibility of exercise during immunotherapy and generate preliminary data on potential immunological effects. These findings will inform the design of future larger trials aimed to optimize supportive care and improve treatment outcomes for patients with advanced RCC.
- Conditions
- Oncology
- Being tested
- HIIT
- Keywords
- Oncology, Exercise, immunotherapy, Renal cell carcinoma, immune-related adverse events, randomized controlled trial, immune function
- Medical subject headings
- Neoplasms, Motor Activity, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
The intervention group will be offered a supervised exercise program consisting of two 60-minute sessions per week, including continuous aerobic exercise and HIIT. Sessions will be supervised by physiotherapists specialized in oncology, and the training load will be tailored to a patient's individual fitness levels throughout the intervention. Following a short warm-up, participants will perform repeated high-intensity cycling intervals targeting 85-95% of their estimated peak heart rate corresponding to a Borg Rating of Perceived Exertion (RPE) 16-18), interspersed with periods of active recovery at light intensity. The HIIT component will be followed by moderate-intensity aerobic exercise at approximately 70% of the estimated heart rate (Borg RPE 13-14), and a cool-down period. In addition, participants will be asked to be physically active for at least 30 minutes at moderate intensity, in accordance with the American College of Sports Medicine (ACSM) guidelines.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | High intensity aerobic interval training during dual immunotherapy Receives: Behavioral: HIIT |
| Usual care control (UC) | No intervention | The control group will receive usual care and will be receive a folder about physical activity recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
Calculated by the proportion of eligible patients that participate. An accrual rate lower than 20% will be defined as not feasible.
Measured: Study enrolment period (approximately 24 months)
Exercise intervention adherence
Adherence will be assesed by attendance and exercise relative dose intensity (ExRDI). Attendence will be assessed by dividing the number of attended sessions by the number of prescribed sessions. ExRDI will be calculated as the percentage of the exercise intensity achieved during the performed sessions relative to the total prescribed exercise intensity expressed as a percentage. The information will be collected using questionnaires and exercise-logs registered by the physical therapists. These logs will be collected by the researcher
Measured: 12 weeks (during intervention period)
Immune-related and exercise-related adverse events
Immune related adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 based on medical records and the patient reported outcomes (PRO)-CTCAE completed by patients before each immunotherapy cycle and at 3-month follow up.
Measured: 24 weeks (during intervention period of 12 weeks, and 12 weeks post intervention)
Secondary outcomes (12)
Body composition
Bioelectrical Impedance Analysis (BIA), Length (cm), Body weight (kg), Muscle mass (kg), Body fat percentage (%). Weight and height will be combined to report BMI in kg/m²
Measured: 12 weeks (Baseline, post-intervention)
Estimated aerobic fitness
Steep ramp test
Measured: 12 weeks (Baseline, post-intervention)
Lower body muscle function
Lower body muscle function will be assessed using a sit-to-stand test
Measured: 12 weeks (Baseline, post-intervention)
Physical activity
Modified Godin Leisure-Time Exercise Questionnaire, Fitbit continuously
Measured: 12 weeks (Baseline, post-intervention)
Health-related quality of life (HRQoL)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire
Measured: 12 weeks (Baseline, post-intervention)
Fatigue
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ FA12) questionnaire
Measured: 12 weeks (Baseline, post-intervention)
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS) questionnaire
Measured: 12 weeks (Baseline, post-intervention)
Sleep
Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: 12 weeks (Baseline, post-intervention)
Diet
World Cancer Research Fund / American Institute for Cancer Research (WCRF/AICR) Cancer Prevention Recommendations Questionnaire
Measured: 12 weeks (Baseline, post-intervention)
ctDNA
Venous blood sampling, concetration ctDNA (ng/mL) next-generation sequencing
Measured: 12 weeks (baseline, 6 weeks, and post-intervention)
Immune cell phenotype and function, and inflammatory markers
Venous blood sampling and flow cytometry to determine frequency (%) of circulating immune cells, functional characteristics of circulating immune cells will be determined using functional assays, inflammatory marker concentrations will measured (pg/mL or ng/mL).
Measured: 12 weeks (baseline, 6 weeks, and post-intervention)
Gut microbiome composition
Taxonomic features and alpha and beta diversity via 16S rRNA marker gene sequencing of feces samples
Measured: 12 weeks (baseline and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start22 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurien M Buffart, PhD, Principal investigator, Radboud University Medical CenterSasja F Mulder, MD, PhD, Principal investigator, Radboud University Medical CenterTheo van Voorthuizen, MD, Principal investigator, Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680556
- Sponsor's protocol ID
- NL-011443
- Other IDs
- NL-011443
- Acronym
- PRIMER
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared via the POLARIS consortium see PROSPERO registry CRD42013003805 or paper: Buffart et al. Systematic Reviews 2013; 2: 75.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07680556
- Acronym / sponsor ID
- PRIMER / NL-011443
- Conditions
- Oncology
- Keywords
- Oncology, Exercise, immunotherapy, Renal cell carcinoma, immune-related adverse events, randomized controlled trial, immune function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 2 Jul 2026 (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 primary aim of this study is to evaluate the feasibility of a supervised high intensity interval training (HIIT) program during first-line dual immune checkpoint inhibitor (ICI) therapy (nivolumab plus ipilimumab) in patients with advanced renal cell carcinoma (RCC). The second aim is to generate preliminary data on the effects of exercise on the immune cell phenotype and function, gut microbiota composition, physical fitness, patient-reported outcomes and clinical outcomes.
This is a two-arm randomized controlled pilot trial in which 30 patients with advanced RCC scheduled to receive first-line nivolumab plus ipilimumab will be randomized in 1:1 ratio to an exercise intervention group or usual care group. The exercise intervention consists of two 60-minute supervised HIIT sessions per week, delivered by oncology-trained physiotherapists and one additional home-based moderate-intensity aerobic exercise sessions per week. The intervention starts with the first cycle of immunotherapy and continues for four treatment cycles. Participants in both groups will receive usual care and general exercise guidelines. Measurements include blood and stool sampling for microbiome and immune parameters analysis, physical fitness assessments, physical fitness monitoring, body composition measurements, and patient-reported outcomes related to quality of life, fatigue, depression, sleep and diet.
Detailed description
There is strong evidence from randomized controlled trials that exercise during cancer treatment can maintain physical fitness, limit fatigue, and enhance health-related quality of life (HRQoL). Some studies also showed that exercise may help patients to better tolerate their treatment. However, most exercise trials have been conducted in patients receiving chemotherapy or radiotherapy, and little is known about the feasibility or effects of exercise during immunotherapy, particularly in patients with advanced RCC.
First-line treatment for patients with advanced RCC often consists of dual ICI treatment with nivolumab plus ipilimumab. While this combination has shown to improve survival, a substantial proportion of patients do not respond, and approximately 44% experience any grade immune-related adverse events. Tumor hypoxia, an immunosuppressive tumor microenvironment, and insufficient infiltration of cytotoxic immune cells are key factors believed to contribute to treatment resistance.
Preclinical studies in mice have shown that aerobic exercise can positively influence the tumor microenvironment through reduced tumor hypoxia, enhanced tumor perfusion, and increased activity and infiltration of cytotoxic immune cells such as CD8+ T cells and natural killer (NK) cells, while reducing immunosuppressive cell populations. In addition, preclinical studies in mice suggested that exercise-induced changes in the gut microbiome can further support immune activation and improve responses to immunotherapy. Despite this promising biological rationale, no clinical studies have evaluated whether supervised exercise is feasible or beneficial in patients with advanced RCC.
The primary objective of this pilot randomized controlled trial is to evaluate the feasibility of a supervised exercise program during first-line dual ICI therapy in patients with advanced RCC. Secondary objectives are to explore the preliminary effects of exercise on immune phenotype and function, inflammatory markers, circulating tumor (ct)DNA, gut microbiome composition, body composition, aerobic fitness, muscle function, physical activity, and patient reported outcomes including HRQoL, fatigue, anxiety, depression, sleep, and diet. In addition, changes in immune function, gut microbiome composition and clinical outcomes will also be explored.
This study is a two-arm randomized controlled trial including 30 adult patients with advanced RCC. Participants will be randomized to the intervention arm that receives a supervised HIIT program in addition to usual care or to a usual care control arm. The intervention consists of two supervised 60-minute HIIT-exercise sessions per week, delivered by oncology trained physiotherapists, combined with one additional home-based moderate intensity exercise session of at least 30 min per week. The intervention starts with the first cycle of immunotherapy and continues for four treatment cycles. Blood and stool samples will be collected at baseline and at 6 weeks and 12 weeks during treatment to assess immune and microbiome changes. In addition, in participants allocated to the exercise intervention group, to evaluate the acute effects of exercise on the immune response, blood samples will be collected immediately before and after a supervised exercise session.
Physical fitness tests, questionnaires and Fitbit to monitor physical activity will be used to evaluate functional and patient-reported outcomes.
This pilot study will provide important information on the feasibility of exercise during immunotherapy and generate preliminary data on potential immunological effects. These findings will inform the design of future larger trials aimed to optimize supportive care and improve treatment outcomes for patients with advanced RCC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Behavioral: HIITHigh intensity aerobic interval training during dual immunotherapy |
| Usual care control (UC) | No intervention | –The control group will receive usual care and will be receive a folder about physical activity recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Diagnosed with advanced RCC with indication for standard-of-care dual ICI treatment.
- Able and willing to give written informed consent.
Key exclusion criteria (5 listed)
- Life expectancy <6 months.
- Unable to perform basic activities of daily living such as walking.
- Presence of cognitive impairment or severe emotional instability (e.g. schizophrenia, Alzheimer's disease, alcohol addiction), at the discretion of the investigator.
- Presence of other disabling comorbidities that may interfere with the ability to perform physical exercise (e.g., heart failure, chronic obstructive pulmonary disease (COPD, GOLD stage 3 or 4), orthopaedic conditions, or neurological disorders such as hernia, paresis, amputation or active rheumatoid arthritis), at the discretion of the investigator.
- Current participation in structured vigorous aerobic and/or resistance exercise ≥ 2 times per week at a level comparable to the intervention
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 |
|---|---|---|
| HIITThe intervention group will be offered a supervised exercise program consisting of two 60-minute sessions per week, including continuous aerobic exercise and HIIT. Sessions will be supervised by physiotherapists specialized in oncology, and the training load will be tailored to a patient's individual fitness levels throughout the intervention. Following a short warm-up, participants will perform repeated high-intensity cycling intervals targeting 85-95% of their estimated peak heart rate corresponding to a Borg Rating of Perceived Exertion (RPE) 16-18), interspersed with periods of active recovery at light intensity. The HIIT component will be followed by moderate-intensity aerobic exercise at approximately 70% of the estimated heart rate (Borg RPE 13-14), and a cool-down period. In addition, participants will be asked to be physically active for at least 30 minutes at moderate intensity, in accordance with the American College of Sports Medicine (ACSM) guidelines. | Behavioural | High Intensity Interval Training (HIIT) |
Primary outcome
Participation rate
Time frame: Study enrolment period (approximately 24 months)
Calculated by the proportion of eligible patients that participate. An accrual rate lower than 20% will be defined as not feasible.
Exercise intervention adherence
Time frame: 12 weeks (during intervention period)
Adherence will be assesed by attendance and exercise relative dose intensity (ExRDI). Attendence will be assessed by dividing the number of attended sessions by the number of prescribed sessions. ExRDI will be calculated as the percentage of the exercise intensity achieved during the performed sessions relative to the total prescribed exercise intensity expressed as a percentage. The information will be collected using questionnaires and exercise-logs registered by the physical therapists. These logs will be collected by the researcher
Immune-related and exercise-related adverse events
Time frame: 24 weeks (during intervention period of 12 weeks, and 12 weeks post intervention)
Immune related adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 based on medical records and the patient reported outcomes (PRO)-CTCAE completed by patients before each immunotherapy cycle and at 3-month follow up.
12 secondary outcomes
Body composition
Time frame: 12 weeks (Baseline, post-intervention)
Estimated aerobic fitness
Time frame: 12 weeks (Baseline, post-intervention)
Lower body muscle function
Time frame: 12 weeks (Baseline, post-intervention)
Physical activity
Time frame: 12 weeks (Baseline, post-intervention)
Health-related quality of life (HRQoL)
Time frame: 12 weeks (Baseline, post-intervention)
Fatigue
Time frame: 12 weeks (Baseline, post-intervention)
Anxiety and depression
Time frame: 12 weeks (Baseline, post-intervention)
Sleep
Time frame: 12 weeks (Baseline, post-intervention)
Diet
Time frame: 12 weeks (Baseline, post-intervention)
ctDNA
Time frame: 12 weeks (baseline, 6 weeks, and post-intervention)
Immune cell phenotype and function, and inflammatory markers
Time frame: 12 weeks (baseline, 6 weeks, and post-intervention)
Gut microbiome composition
Time frame: 12 weeks (baseline and post-intervention)
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared via the POLARIS consortium see PROSPERO registry CRD42013003805 or paper: Buffart et al. Systematic Reviews 2013; 2: 75.
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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.
Laurien M Buffart, PhD principal investigator
Radboud University Medical Center
Sasja F Mulder, MD, PhD principal investigator
Radboud University Medical Center
Theo van Voorthuizen, MD principal investigator
Rijnstate
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT in people with Oncology, run by Radboud University Medical Center at 2 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 3 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Laurien Buffart, PhD (+31 24 3667310, laurien.buffart@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: Study enrolment period (approximately 24 months)). The study lists 3 primary outcomes in all. 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 28 Aug 2026.