Lung Cancer (NSCLC)REHAB-CBNPCNCT07434947
Study of Three Endpoints to Assess the Benefit of Rehabilitation in Patients With Advanced Non-small Cell Lung Cancer Controlled After at Least 6 Months of Systemic Treatment
An observational study of Lung Cancer (NSCLC), run by University Hospital, Grenoble at 3 sites in France.
Trial summary
The objective of this study is to identify an outcome that is relevant for assessing the benefit of rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease has been stable or responding for at least 6 months with systemic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- How many people
- 63 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Apr 2026to 14 Oct 2027
- Phase
- Observational
- 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
Study population: The study population includes patients with metastatic or locally advanced non-small cell lung cancer whose tumor disease is controlled and who are at least 6 months post-treatment with any anti-tumor therapy. They must have a complaint related to physical activity.
Who may be able to join
- Adult patients treated for NSCLC at CHUGA, CHMS, or CHANGE
- Locally advanced or metastatic NSCLC
- Tumor disease controlled for at least 6 months following any type of anti-tumor treatment
- ECOG Performance Status 0 to 2
- Patient reporting functional complaints related to physical activity
- Covered by the national health insurance system
Who cannot join
- Initial management of the tumor disease started ≥ 2 years ago
- Residual toxicity of grade ≥ 2
- Estimated life expectancy less than 6 months (at the discretion of the investigator)
- Patient with an absolute contraindication to physical activity at the time of consultation (e.g., unstable angina; acute intercurrent event...)
- Subject currently in an exclusion period from another study or participating in an interventional study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Etienne FOULON contact
France3 sites, 3 recruiting
- Not yet recruiting
Centre Hospitalier Annecy Genevois
Annecy, 74370
Valerie PAULUS, vpaulus@ch-annecygenevois.fr
Océane VENDRASCO, ovendrasco@ch-annecygenevois.fr
- Recruiting
CH Métropole Savoie
Chambéry, 73 100
Julian PINSOLLE, julian.pinsolle@ch-metropole-savoie.fr
Julian PINSOLLE
- Not yet recruiting
CHU Grenoble Alpes
Grenoble, 38043
Anne-Claire TOFFART, 33 +(0)4 76 76 68 31, AToffart@chu-grenoble.fr
Etienne FOULON, EFoulon1@chu-grenoble.fr
About this study
The objective of this study is to identify an outcome that is relevant for assessing the benefit of rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease has been stable or responding for at least 6 months with systemic treatment.
Many people living with lung cancer experience asthenia, which reduces daily activity, independence, and quality of life.
Read more
Regular physical activity (PA) is recommended for the management of all chronic diseases, including cancer. PA can be done independently by the patient or supervised by adapted physical activity instructors (EAPA) at home or in a day hospital (HDJ) in medical and rehabilitation care departments (SMR), where it is covered by social security.
Rehabilitation program and physical activity may help improve strength, function, and social participation, for patients with non-small cell lung cancer .
In this study, patients will participate in a 3-month rehabilitation program. We will measure quality of life, hand grip strength, and the Five Times Sit to Stand Test, before and after the program. Other measures will include daily step counts, nutrition, overall health status, continuation of cancer treatment, program adherence, and participant satisfaction.
About 63 participants will be recruited in several hospitals, including CHUGA, CHMS and CHANGE. This patients will be able to choose a program that suits them and is available as part of they care. We are expecting 50 patients to participate in one of the rehabilitation program.
The main goal is to identify the most useful outcomes to assess in future studies that will compare different rehabilitation approaches for people with lung cancer.
Read the detailed description
This study (REHAB-CBNPC) is a prospective, multicenter, observational trial coordinated by Pr. Anne-Claire Toffart and sponsored by CHU Grenoble Alpes. It aims to identify the most relevant outcome measure to evaluate the benefit of rehabilitation programs in patients with advanced or metastatic non-small cell lung cancer whose disease remains controlled after at least 6 months of systemic treatment.
Regular physical activity is recommended for people with chronic diseases, including cancer. In non-small cell lung cancer, preoperative and postoperative rehabilitation has demonstrated benefits, particularly in patients with impaired respiratory function. However, evidence regarding rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease is controlled at distance from initial treatment remains scarce. These patients frequently experience cancer-related fatigue, reduced activity levels, and impaired quality of life, highlighting the need for adapted rehabilitation approaches.
Eligible participants will be adults with locally advanced or metastatic non-small cell lung cancer, ECOG-PS 0-2, and a self-reported functional limitation, recruited from three centers in the Auvergne-Rhône-Alpes region of France (CHU Grenoble Alpes, CH Chambéry, CH Annecy-Genevois). Rehabilitation programs will be delivered according to local practice, either in specialized rehabilitation units (SMR), hospital-based day programs, or at home with adapted physical activity providers.
Approximately 63 patients will be enrolled to participate in a study on physical activity, they will be recruited at one of the participating centers during consultations with their referring oncologist. anticipating that about 50 will complete a rehabilitation program. If they meet all the inclusion criteria and do not have any exclusion criteria, they will be offered the opportunity to participate in a study on physical activity. They will then have the choice of whether or not to participate.
If they agree, they will be able to choose a rehabilitation program that suits them and is available as part of their care.
Each participant will be followed for 3 months, and data will be collected through electronic case report forms (REDCap).
This exploratory study will evaluate three main outcomes before and after a 3-month rehabilitation program: quality of life (EQ-5D-5L), hand grip strength, and the five-times sit-to-stand test. The study will also assess feasibility and sensitivity to change of additional measures, including step counts, physical activity and sedentary behavior (ONAPS-PAQ), nutritional status, performance status (ECOG-PS), continuation of systemic treatment, adherence to the program, causes of non-participation, and patient satisfaction (CSQ-8).
Quantitative variables will be described by their means and standard deviations, as well as medians and interquartile ranges. Qualitative variables will be described by the associated numbers and percentages. Any normality will be verified graphically.
The expected outcomes include a better understanding of feasibility, adherence, and sensitivity of candidate endpoints. Results will inform the selection of the most appropriate primary endpoint for future randomized controlled trials comparing rehabilitation strategies in advanced non-small cell lung cancer
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- readaptation, Physical activity
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic or locally advanced non-small cell lung cancer. | The study population includes patients with metastatic or locally advanced non-small cell lung cancer whose tumour disease is controlled and who are at least 6 months into any anti-tumour treatment. They must have a functional complaint concerning physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand-grip
Hand grip strength is measured with a hand dynamometer. It is a measure of grip strength in kilograms, which is associated with muscle mass.
The subject holds the device in one hand, usually with the elbow at 90° and the wrist straight. On signal, they squeeze as hard as possible for a few seconds. The test is repeated 2-3 times for each hand, and the best or average value is recorded.
Measured: periprocedural of the exercise rehabilitation program
EQ5DL Score
EQ5DL is a score about life quality. It includes two part:
The first part assesses health in five dimensions, each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
The second part consists of a visual analogue scale (VAS) on which rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: periprocedural of the exercise rehabilitation program
Five Times Sit To Stand
The subject sits on a chair , with arms crossed over the chest. On the tester's signal, the subject stands up fully and sits back down five times as quickly as possible without using the arms for support. The time needed to complete the five repetitions is measured.
Measured: periprocedural of the exercise rehabilitation program
Secondary outcomes (9)
ONAPS-PAQ test
The Onaps-PAQ questionnaire assesses the level of physical activity and sedentary behavior during a typical week for the adult population. It is divided into three parts and 21 questions: activities at work, trips for practical purposes, and leisure or home activities. This questionnaire also assesses sedentary behavior in all areas of life (travel, work, leisure).
Patients are considered to be very active, active, or inactive. There are also three levels of sedentary behavior: low, moderate, and high.
Measured: periprocedural of the exercise rehabilitation program
ECOG-PS
It describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The ECOG Performance Status Scale measure how the disease impacts a patient's daily living abilities, known to physicians and researchers as a patient's performance status.
Measured: periprocedural of the exercise rehabilitation program
CSQ-8
It is the Client Satisfaction Questionnaire. It will be use to measure and assess consumer satisfaction with health and human services. There are 8 questions, total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: through study completion, an average of 3 months
Average number of steps in the previous week (using smartphone app)
If it's available, on a app, it is the number of steps the week before.
Measured: periprocedural of the exercise rehabilitation program
Continuation of oncological treatment
We will collect information on the patient's cancer treatment:
- Same as before rehabilitation
- Treatment modified due to tumor progression
- Treatment discontinued because no longer indicated (no tumor progression)
- Treatment discontinued because of palliative care only
Measured: through study completion, an average of 3 months
Weight (in kg)
Measured: periprocedural of the exercise rehabilitation program
Reason for refusing/not participating in a program
If patients agree to participate in the study but do not wish to participate in any rehabilitation program, we will collect the reason for this.
Measured: At Baseline
Adherence to the rehabilitation program.
We will collect data if the patient has completed the entire program until the end (with the possibility of a few sessions not being completed).
Measured: through study completion, an average of 3 months
Adverse events
We will collect adverse events related to the tumor disease (including treatment and cancer itself) or the rehabilitation program, as well as the consequences.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Apr 2026
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2027 (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 Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Claire TOFFART, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434947
- Sponsor's protocol ID
- 38RC25.0268
- Other IDs
- 2025-A01837-42
- Acronym
- REHAB-CBNPC
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819.
PubMed 35393316Catho H, Guigard S, Toffart AC, Frey G, Chollier T, Brichon PY, Roux JF, Sakhri L, Bertrand D, Aguirre C, Gorain S, Wuyam B, Arbib F, Borel JC. What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study. BMJ Open. 2021 Feb 10;11(2):e041907. doi: 10.1136/bmjopen-2020-041907.
PubMed 33568371
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Three Endpoints to Assess the Benefit of Rehabilitation in Patients With Advanced Non-small Cell Lung Cancer Controlled After at Least 6 Months of Systemic Treatment
- ClinicalTrials.gov ID
- NCT07434947
- Acronym / sponsor ID
- REHAB-CBNPC / 38RC25.0268
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- readaptation, Physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2027 (estimated)
- First posted
- 27 Feb 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 objective of this study is to identify an outcome that is relevant for assessing the benefit of rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease has been stable or responding for at least 6 months with systemic treatment.
Many people living with lung cancer experience asthenia, which reduces daily activity, independence, and quality of life.
Regular physical activity (PA) is recommended for the management of all chronic diseases, including cancer. PA can be done independently by the patient or supervised by adapted physical activity instructors (EAPA) at home or in a day hospital (HDJ) in medical and rehabilitation care departments (SMR), where it is covered by social security.
Rehabilitation program and physical activity may help improve strength, function, and social participation, for patients with non-small cell lung cancer .
In this study, patients will participate in a 3-month rehabilitation program. We will measure quality of life, hand grip strength, and the Five Times Sit to Stand Test, before and after the program. Other measures will include daily step counts, nutrition, overall health status, continuation of cancer treatment, program adherence, and participant satisfaction.
About 63 participants will be recruited in several hospitals, including CHUGA, CHMS and CHANGE. This patients will be able to choose a program that suits them and is available as part of they care. We are expecting 50 patients to participate in one of the rehabilitation program.
The main goal is to identify the most useful outcomes to assess in future studies that will compare different rehabilitation approaches for people with lung cancer.
Detailed description
This study (REHAB-CBNPC) is a prospective, multicenter, observational trial coordinated by Pr. Anne-Claire Toffart and sponsored by CHU Grenoble Alpes. It aims to identify the most relevant outcome measure to evaluate the benefit of rehabilitation programs in patients with advanced or metastatic non-small cell lung cancer whose disease remains controlled after at least 6 months of systemic treatment.
Regular physical activity is recommended for people with chronic diseases, including cancer. In non-small cell lung cancer, preoperative and postoperative rehabilitation has demonstrated benefits, particularly in patients with impaired respiratory function. However, evidence regarding rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease is controlled at distance from initial treatment remains scarce. These patients frequently experience cancer-related fatigue, reduced activity levels, and impaired quality of life, highlighting the need for adapted rehabilitation approaches.
Eligible participants will be adults with locally advanced or metastatic non-small cell lung cancer, ECOG-PS 0-2, and a self-reported functional limitation, recruited from three centers in the Auvergne-Rhône-Alpes region of France (CHU Grenoble Alpes, CH Chambéry, CH Annecy-Genevois). Rehabilitation programs will be delivered according to local practice, either in specialized rehabilitation units (SMR), hospital-based day programs, or at home with adapted physical activity providers.
Approximately 63 patients will be enrolled to participate in a study on physical activity, they will be recruited at one of the participating centers during consultations with their referring oncologist. anticipating that about 50 will complete a rehabilitation program. If they meet all the inclusion criteria and do not have any exclusion criteria, they will be offered the opportunity to participate in a study on physical activity. They will then have the choice of whether or not to participate.
If they agree, they will be able to choose a rehabilitation program that suits them and is available as part of their care.
Each participant will be followed for 3 months, and data will be collected through electronic case report forms (REDCap).
This exploratory study will evaluate three main outcomes before and after a 3-month rehabilitation program: quality of life (EQ-5D-5L), hand grip strength, and the five-times sit-to-stand test. The study will also assess feasibility and sensitivity to change of additional measures, including step counts, physical activity and sedentary behavior (ONAPS-PAQ), nutritional status, performance status (ECOG-PS), continuation of systemic treatment, adherence to the program, causes of non-participation, and patient satisfaction (CSQ-8).
Quantitative variables will be described by their means and standard deviations, as well as medians and interquartile ranges. Qualitative variables will be described by the associated numbers and percentages. Any normality will be verified graphically.
The expected outcomes include a better understanding of feasibility, adherence, and sensitivity of candidate endpoints. Results will inform the selection of the most appropriate primary endpoint for future randomized controlled trials comparing rehabilitation strategies in advanced non-small cell lung cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic or locally advanced non-small cell lung cancer. | – | –The study population includes patients with metastatic or locally advanced non-small cell lung cancer whose tumour disease is controlled and who are at least 6 months into any anti-tumour treatment. They must have a functional complaint concerning physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with metastatic or locally advanced non-small cell lung cancer whose tumor disease is controlled and who are at least 6 months post-treatment with any anti-tumor therapy. They must have a complaint related to physical activity.
Key inclusion criteria (6 listed)
- Adult patients treated for NSCLC at CHUGA, CHMS, or CHANGE
- Locally advanced or metastatic NSCLC
- Tumor disease controlled for at least 6 months following any type of anti-tumor treatment
- ECOG Performance Status 0 to 2
- Patient reporting functional complaints related to physical activity
Key exclusion criteria (5 listed)
- Initial management of the tumor disease started ≥ 2 years ago
- Residual toxicity of grade ≥ 2
- Estimated life expectancy less than 6 months (at the discretion of the investigator)
- Patient with an absolute contraindication to physical activity at the time of consultation (e.g., unstable angina; acute intercurrent event...)
- Subject currently in an exclusion period from another study or participating in an interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hand-grip
Time frame: periprocedural of the exercise rehabilitation program
Hand grip strength is measured with a hand dynamometer. It is a measure of grip strength in kilograms, which is associated with muscle mass. The subject holds the device in one hand, usually with the elbow at 90° and the wrist straight. On signal, they squeeze as hard as possible for a few seconds. The test is repeated 2-3 times for each hand, and the best or average value is recorded.
EQ5DL Score
Time frame: periprocedural of the exercise rehabilitation program
EQ5DL is a score about life quality. It includes two part: The first part assesses health in five dimensions, each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part consists of a visual analogue scale (VAS) on which rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Five Times Sit To Stand
Time frame: periprocedural of the exercise rehabilitation program
The subject sits on a chair , with arms crossed over the chest. On the tester's signal, the subject stands up fully and sits back down five times as quickly as possible without using the arms for support. The time needed to complete the five repetitions is measured.
9 secondary outcomes
ONAPS-PAQ test
Time frame: periprocedural of the exercise rehabilitation program
ECOG-PS
Time frame: periprocedural of the exercise rehabilitation program
CSQ-8
Time frame: through study completion, an average of 3 months
Average number of steps in the previous week (using smartphone app)
Time frame: periprocedural of the exercise rehabilitation program
Continuation of oncological treatment
Time frame: through study completion, an average of 3 months
Weight (in kg)
Time frame: periprocedural of the exercise rehabilitation program
Reason for refusing/not participating in a program
Time frame: At Baseline
Adherence to the rehabilitation program.
Time frame: through study completion, an average of 3 months
Adverse events
Time frame: through study completion, an average of 3 months
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 13 Oct 2026.
- Background: PubMed 35393316Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819.
- Background: PubMed 33568371Catho H, Guigard S, Toffart AC, Frey G, Chollier T, Brichon PY, Roux JF, Sakhri L, Bertrand D, Aguirre C, Gorain S, Wuyam B, Arbib F, Borel JC. What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study. BMJ Open. 2021 Feb 10;11(2):e041907. doi: 10.1136/bmjopen-2020-041907.
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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.
Etienne FOULON contact
Anne-Claire TOFFART principal investigator
CHU Grenoble Alpes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC), run by University Hospital, Grenoble at 3 sites 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 6 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 13 Oct 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 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 Anne-Claire TOFFART (33 +(0)4 76 76 68 31, AToffart@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand-grip (time frame: periprocedural of the exercise rehabilitation program). 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?
On the ClinicalTrials.gov record for NCT07434947, 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 13 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.