Breast Cancer Survivorse-ACTNCT07721753
Exergames-acceptance and Commitment Therapy(e-ACT) for Breast Cancer Depression and Anxiety: A Randomized Controlled Trial
A study testing exergames-acceptance and commitment therapy (e-ACT) and Acceptance and commitment therapy (ACT) in people with Breast Cancer Survivors and Depression Anxiety Disorder, run by Universiti Sains Malaysia at 1 site in China.
Trial summary
The goal of this three arm, double-blind, randomized controlled trial is to learn if an exergame-acceptance and commitment therapy (e-ACT) program can treat depression and anxiety in breast cancer patients, compared to acceptance and commitment therapy (ACT) alone and treatment-as-usual. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivors, Depression Anxiety Disorder
- What is being tested?
- exergames-acceptance and commitment therapy (e-ACT) and Acceptance and commitment therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
The inclusion criteria include:
- Newly diagnosed breast cancer patients and patients with recurrent breast cancer confirmed by histopathological report, regardless of the stage of cancer.
- Those with HADS score of 8 or higher in both Depression and Anxiety sub-scales of the HADS.
- Patients who had been treated with surgery or were undergoing the standard regime of clinical anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.).
- Age 18 years old and above.
- Patients who were able to read and understand written Chinese.
The exclusion criteria are:
- Pregnant women，considered for the following reasons: Pregnancy involves significant hormonal and physical changes that could affect the participant's response to the e-ACT; the safety of e-ACT to the unborn child was of concern.
- Those who have current and lifetime history of engaging in any psychotherapy
- Those who consumed alcohol and illicit drugs .
- Those who has current and lifetime history of other psychiatric illnesses, such as psychotic disorders (schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder, and autism spectrum disorder
- Those who are on medications that can induce psychiatric symptoms, such as cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers), dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine medications (triptans), hormonal agents (corticosteroids, oral contraceptives, gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents (interferons), and levodopa.Or those who ccurrently using any psychotropic medication.
- Patient who has suicidal tendency.
- those who are physically unfit to answer questionnaires. (those are bed-bound or too weak to answer the questionnaire).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453100
Lifang zhang, +86 15836138029, Zhanglf_science@outlook.com
About this study
Official title: The Efficacy of Exergames-acceptance and Commitment Therapy Program for Treatment of Depression and Other Psychological Complications in Breast Cancer: Comparison With Acceptance and Commitment Therapy Alone and Treatment-as-usual in a Randomized Controlled Trial
The goal of this three arm, double-blind, randomized controlled trial is to learn if an exergame-acceptance and commitment therapy (e-ACT) program can treat depression and anxiety in breast cancer patients, compared to acceptance and commitment therapy (ACT) alone and treatment-as-usual. The main question it aims to answer is:
Is there a difference in the effectiveness of the e-ACT program in reducing depressive and anxiety symptoms, cancer-related fatigue, experiential avoidance, and serum IL-6 levels, while increasing BDNF and improving posttraumatic growth and quality of life among breast cancer patients, compared to ACT alone and treatment-as-usual, measured at baseline, 8 weeks (post-intervention), and 12 weeks after the intervention (follow-up)?
Read more
Researchers will compare the e-ACT group, the ACT-alone group, and the treatment-as-usual group to see if the e-ACT program yields superior outcomes in reducing psychological distress and improving well-being.
Participants will:
Be randomly assigned to one of three groups: (1) e-ACT (exergame + ACT), (2) ACT alone, or (3) treatment-as-usual (general patient education).
Attend an 8-week program (one session per week) if in the e-ACT or ACT group; the control group continues their usual care.
Complete questionnaires at three time points (baseline, 8 weeks, and 20 weeks) to assess depression, anxiety, quality of life, posttraumatic growth, valued living, experiential avoidance, and cancer-related fatigue.
Provide blood samples at pre-intervention and post-intervention (week 8) for analysis of interleukin-6 (IL-6) and brain-derived neurotrophic factor (BDNF) biomarkers.
- Being tested
- exergames-acceptance and commitment therapy (e-ACT), Acceptance and commitment therapy (ACT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exergames-acceptance and commitment therapy (e-ACT)Behavioural
The exergame-based Acceptance and Commitment Therapy (e-ACT) is an 8-week behavioral intervention that integrates Acceptance and Commitment Therapy (ACT) with exergame-based physical activity using Nintendo Ring Fit Adventure. The intervention combines psychological skills training based on ACT principles, including acceptance, cognitive defusion, mindfulness, values clarification, and committed action, with structured game-based physical activity. Participants will receive weekly supervised sessions designed to promote psychological well-being, physical activity engagement among cancer patients.
Acceptance and commitment therapy (ACT)Behavioural
Acceptance and Commitment Therapy (ACT) is an 8-week structured psychological intervention based on psychological flexibility theory. The program focuses on acceptance, cognitive defusion, mindfulness, self-as-context, values clarification, and committed action to help participants develop adaptive responses to cancer-related psychological distress.
| Study group | Role | What they receive |
|---|---|---|
| e-ACT Intervention Group | Experimental | Participants in the e-ACT group receive an 8-week combined intervention consisting of weekly ACT sessions and three weekly exergame sessions. The program is delivered at the psychology labs of XXMU, with each weekly session held at a fixed time and venue to ensure standardization. Receives: Behavioral: exergames-acceptance and commitment therapy (e-ACT) |
| ACT Intervention Group | Active comparator | Participants in the ACT group receive an 8-week standard ACT program, with one 50-minute session per week delivered at a fixed time and venue. Receives: Behavioral: Acceptance and commitment therapy (ACT) |
| Treatment-as-usual（TAU） | No intervention | Participants in the control group receive treatment-as-usual (TAU), consisting of 8 weekly sessions providing general psychological support (e.g., reassurance, problem identification, and deep breathing exercises), with equal therapist time and attention as the intervention groups, delivered at a fixed time and venue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Symptoms Measured by HADS-D Score
The Chinese version of the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) will be used to assess depressive symptoms. The HADS-D consists of 7 items, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms.
Measured: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Anxiety Symptoms Measured by HADS-A Score
The Chinese version of the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) will be used to assess depressive symptoms. The HADS-A consists of 7 items, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms.
Measured: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Secondary outcomes (5)
Change in Quality of Life Measured by FACT-B Total Score
The Chinese version of the Functional Assessment of Cancer Therapy-Breast (FACT-B) will be used to assess health-related quality of life in breast cancer patients. The FACT-B consists of 39 items across five subscales. Each item is rated on a 5-point Likert scale ranging from 0 to 4. Higher scores indicate better quality of life.
Measured: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Posttraumatic Growth Measured by PTGI-SF Total Score
The Chinese version of the Posttraumatic Growth Inventory-Short Form (PTGI-SF) will be used to assess positive psychological changes following cancer experience. The PTGI-SF consists of 10 items across five domains. Higher scores indicate greater posttraumatic growth.
Measured: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Cancer-Related Fatigue Measured by BFI Score
The Chinese version of the Brief Fatigue Inventory (BFI) will be used to assess cancer-related fatigue severity and its interference with daily functioning. This one-page questionnaire uses an 11-point scale (0-10) to assess fatigue severity and fatigue-related interference. Three items assess fatigue severity at its "worst," "usual," and "now" during the past 24 hours, with 0 indicating "no fatigue" and 10 indicating "fatigue as bad as you can imagine." Six additional items assess how much fatigue has interfered with different aspects of the patient's life during the past 24 hours. Higher scores indicate greater fatigue severity and interference.
Measured: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Psychological Flexibility Measured by AAQ-II Score
The Chinese version of the Acceptance and Action Questionnaire-II (AAQ-II) will be used to assess experiential avoidance and psychological inflexibility. The AAQ-II contains seven items, and each item is rated on a 7-point Likert scale ranging from 1 (never true) to 7 (always true). Higher scores indicate greater experiential avoidance and psychological inflexibility.
Measured: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Valued Living Measured by VLQ Score
The Chinese version of the Valued Living Questionnaire (VLQ) will be used to assess consistency between personal values and daily actions. The VLQ assesses 10 valued domains, with each domain rated on two dimensions: the importance of the value and the consistency of actions with that value. Each dimension is rated on a 10-point Likert scale ranging from 1 (not at all important/not at all consistent) to 10 (extremely important/perfectly consistent). Higher scores indicate greater valued living.
Measured: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Mar 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Lifang, Universiti Sains Malaysia
- Investigators
- Lifang Zhang, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721753
- Sponsor's protocol ID
- USM-eACT-BC-RCT-001
- Other IDs
- EC-025-213
- Acronym
- e-ACT
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fawson S, Moon Z, Novogrudsky K, Moxham F, Forster K, Tribe I, Moss-Morris R, Johnson C, Hughes LD. Acceptance and commitment therapy processes and their association with distress in cancer: a systematic review and meta-analysis. Health Psychol Rev. 2024 Sep;18(3):456-477. doi: 10.1080/17437199.2023.2261518. Epub 2023 Oct 4.
PubMed 37746724Tough D, Robinson J, Gowling S, Raby P, Dixon J, Harrison SL. The feasibility, acceptability and outcomes of exergaming among individuals with cancer: a systematic review. BMC Cancer. 2018 Nov 21;18(1):1151. doi: 10.1186/s12885-018-5068-0.
PubMed 30463615Mosher CE, Secinti E, Li R, Hirsh AT, Bricker J, Miller KD, Schneider B, Storniolo AM, Mina L, Newton EV, Champion VL, Johns SA. Acceptance and commitment therapy for symptom interference in metastatic breast cancer patients: a pilot randomized trial. Support Care Cancer. 2018 Jun;26(6):1993-2004. doi: 10.1007/s00520-018-4045-0. Epub 2018 Jan 12.
PubMed 29327085Hulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. Eur J Cancer Care (Engl). 2015;24(1):15-27. doi: 10.1111/ecc.12223. Epub 2014 Aug 6.
PubMed 25100576Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
PubMed 16300724
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Exergames-acceptance and Commitment Therapy Program for Treatment of Depression and Other Psychological Complications in Breast Cancer: Comparison With Acceptance and Commitment Therapy Alone and Treatment-as-usual in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07721753
- Acronym / sponsor ID
- e-ACT / USM-eACT-BC-RCT-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 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 goal of this three arm, double-blind, randomized controlled trial is to learn if an exergame-acceptance and commitment therapy (e-ACT) program can treat depression and anxiety in breast cancer patients, compared to acceptance and commitment therapy (ACT) alone and treatment-as-usual. The main question it aims to answer is:
Is there a difference in the effectiveness of the e-ACT program in reducing depressive and anxiety symptoms, cancer-related fatigue, experiential avoidance, and serum IL-6 levels, while increasing BDNF and improving posttraumatic growth and quality of life among breast cancer patients, compared to ACT alone and treatment-as-usual, measured at baseline, 8 weeks (post-intervention), and 12 weeks after the intervention (follow-up)?
Researchers will compare the e-ACT group, the ACT-alone group, and the treatment-as-usual group to see if the e-ACT program yields superior outcomes in reducing psychological distress and improving well-being.
Participants will:
Be randomly assigned to one of three groups: (1) e-ACT (exergame + ACT), (2) ACT alone, or (3) treatment-as-usual (general patient education).
Attend an 8-week program (one session per week) if in the e-ACT or ACT group; the control group continues their usual care.
Complete questionnaires at three time points (baseline, 8 weeks, and 20 weeks) to assess depression, anxiety, quality of life, posttraumatic growth, valued living, experiential avoidance, and cancer-related fatigue.
Provide blood samples at pre-intervention and post-intervention (week 8) for analysis of interleukin-6 (IL-6) and brain-derived neurotrophic factor (BDNF) biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| e-ACT Intervention Group | Experimental | Behavioral: exergames-acceptance and commitment therapy (e-ACT)Participants in the e-ACT group receive an 8-week combined intervention consisting of weekly ACT sessions and three weekly exergame sessions. The program is delivered at the psychology labs of XXMU, with each weekly session held at a fixed time and venue to ensure standardization. |
| ACT Intervention Group | Active comparator | Behavioral: Acceptance and commitment therapy (ACT)Participants in the ACT group receive an 8-week standard ACT program, with one 50-minute session per week delivered at a fixed time and venue. |
| Treatment-as-usual（TAU） | No intervention | –Participants in the control group receive treatment-as-usual (TAU), consisting of 8 weekly sessions providing general psychological support (e.g., reassurance, problem identification, and deep breathing exercises), with equal therapist time and attention as the intervention groups, delivered at a fixed time and venue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| exergames-acceptance and commitment therapy (e-ACT)The exergame-based Acceptance and Commitment Therapy (e-ACT) is an 8-week behavioral intervention that integrates Acceptance and Commitment Therapy (ACT) with exergame-based physical activity using Nintendo Ring Fit Adventure. The intervention combines psychological skills training based on ACT principles, including acceptance, cognitive defusion, mindfulness, values clarification, and committed action, with structured game-based physical activity. Participants will receive weekly supervised sessions designed to promote psychological well-being, physical activity engagement among cancer patients. | Behavioural | e-ACT Intervention Group |
| Acceptance and commitment therapy (ACT)Acceptance and Commitment Therapy (ACT) is an 8-week structured psychological intervention based on psychological flexibility theory. The program focuses on acceptance, cognitive defusion, mindfulness, self-as-context, values clarification, and committed action to help participants develop adaptive responses to cancer-related psychological distress. | Behavioural | ACT Intervention Group |
Primary outcome
Change in Depression Symptoms Measured by HADS-D Score
Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
The Chinese version of the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) will be used to assess depressive symptoms. The HADS-D consists of 7 items, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms.
Change in Anxiety Symptoms Measured by HADS-A Score
Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
The Chinese version of the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) will be used to assess depressive symptoms. The HADS-A consists of 7 items, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms.
5 secondary outcomes
Change in Quality of Life Measured by FACT-B Total Score
Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Posttraumatic Growth Measured by PTGI-SF Total Score
Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Cancer-Related Fatigue Measured by BFI Score
Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Psychological Flexibility Measured by AAQ-II Score
Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.
Change in Valued Living Measured by VLQ Score
Time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks 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 23 Jul 2026.
- Background: PubMed 37746724Fawson S, Moon Z, Novogrudsky K, Moxham F, Forster K, Tribe I, Moss-Morris R, Johnson C, Hughes LD. Acceptance and commitment therapy processes and their association with distress in cancer: a systematic review and meta-analysis. Health Psychol Rev. 2024 Sep;18(3):456-477. doi: 10.1080/17437199.2023.2261518. Epub 2023 Oct 4.
- Background: PubMed 30463615Tough D, Robinson J, Gowling S, Raby P, Dixon J, Harrison SL. The feasibility, acceptability and outcomes of exergaming among individuals with cancer: a systematic review. BMC Cancer. 2018 Nov 21;18(1):1151. doi: 10.1186/s12885-018-5068-0.
- Background: PubMed 29327085Mosher CE, Secinti E, Li R, Hirsh AT, Bricker J, Miller KD, Schneider B, Storniolo AM, Mina L, Newton EV, Champion VL, Johns SA. Acceptance and commitment therapy for symptom interference in metastatic breast cancer patients: a pilot randomized trial. Support Care Cancer. 2018 Jun;26(6):1993-2004. doi: 10.1007/s00520-018-4045-0. Epub 2018 Jan 12.
- Background: PubMed 25100576Hulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. Eur J Cancer Care (Engl). 2015;24(1):15-27. doi: 10.1111/ecc.12223. Epub 2014 Aug 6.
- Background: PubMed 16300724Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Lifang Zhang principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exergames-acceptance and commitment therapy (e-ACT) and Acceptance and commitment therapy (ACT) in people with Breast Cancer Survivors and Depression Anxiety Disorder, run by Universiti Sains Malaysia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Jul 2026. 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 China. 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 Lifang Zhang (+86 15836138029, Zhanglf_science@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Symptoms Measured by HADS-D Score (time frame: pre-intervention, immediately post-intervention (8 weeks) and 12 weeks post-intervention.). The study lists 2 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 NCT07721753, which also lists 5 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 23 Jul 2026.