Breast CancerIC-GrowthNCT07108517
A Manualized Post-Traumatic Growth Intervention for People With Cancer in Greece - IC-Growth
A study testing IC-Growth ACT-Based Support Program in people with Breast Cancer and Colon Cancer, run by Centre for Research and Technology Hellas at 1 site in Greece.
Trial summary
Cancer can be a very traumatic experience for the people affected and the majority of the psychological literature focuses on this. Less proliferated and researched is the increasingly recognized fact that as a result of struggling with such traumatic adversities, some people experience what is known as post-traumatic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Colon Cancer, Head and Neck Cancers
- What is being tested?
- IC-Growth ACT-Based Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 years)
- Having a diagnosis of a. Breast Cancer, b. Colorectal Cancer, or c. Head and Neck Cancer.
- Having concluded the planned chemotherapy courses and related hospital admissions
- Having no more than 5 years since the initial diagnosis.
Who cannot join
- Being in active psychological or psychiatric treatment
- Having an unmanaged mental health difficulty
- Having a severe cognitive impairment
- Being unable to give informed consent
- Being unable to speak or read Greek
- Having one or more relapses
- Diagnosed with another type of cancer within 5 years prior to recruitment.
- Having less than one-year life expectancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital
Thessaloniki, 54636
Christina Karamanidou, Psychology, PhD, +306949576105, ckaramanidou@certh.gr
About this study
Official title: A Manualized Post-Traumatic Growth Intervention for People With Cancer in Greece - IC-Growth. The Overarching Aim of IC-Growth is to Promote Psychosocial Care and Support for People With Cancer Using Acceptance and Committment Therapy.
Cancer can be a very traumatic experience for the people affected and the majority of the psychological literature focuses on this. Less proliferated and researched is the increasingly recognized fact that as a result of struggling with such traumatic adversities, some people experience what is known as post-traumatic growth (PTG). PTG not only allows them to overcome their trauma (e.g., impact of cancer) and return to pre-diagnosis functioning (e.g., health, wellbeing, employment) but also results in them going over and above their previous state (e.g., increased resilience). This renders PTG an important phenomenon that could be enhanced as part of the support people with cancer receive. IC-Growth has two interconnected paths, namely a research one and another of health policy and best practice recommendations. On the first path, is a sequence of three studies, starting with a systematic review, followed by a cross-sectional study and concludes with a randomized control trial (RCT). The systematic review and close collaboration with experts (e.g., patient associations) will lead to the development of a novel manual to facilitate PTG in groups of people with cancer. The cross-sectional study will explore relationships between variables (e.g., PTG, quality of life, biological variables, illness perceptions, distress, anxiety, depression) in people with cancer (n = 150-180). Lastly, the RCT will evaluate the intervention's effects among three different groups (breast, colorectal, and head and neck cancers, n = 50-60 per group). On the other path, is the development of health policy and best practice recommendations regarding the psychosocial support of people with cancer in Greece. The project's results will be disseminated to stakeholders who provide support to people with cancer (e.g., oncologists, surgeons, psychologists, psychiatrists), through professional associations, a conference on "Psychosocial Support in Oncology", and publications in scientific journals. Overall, IC-Growth is a multidisciplinary project (i.e., psychology, medical, patient organizations, health policy) and joins the clinical, research and policy fields together to workable actions leading to empowering the wider community of people with cancer and improving their care.
Read the detailed description
Detailed Description IC-Growth is a 24-month, multidisciplinary research and clinical project aimed at enhancing psychosocial care for adults with cancer by promoting post-traumatic growth (PTG)-positive psychological changes following traumatic life crises. While most research emphasizes the negative psychological effects of cancer, IC-Growth focuses on understanding and facilitating PTG as a mechanism to improve well-being, resilience, and quality of life (QoL) beyond pre-diagnosis levels.
The project has two interconnected components:
Research - A sequence of three studies to build, test, and evaluate a novel, manualized PTG intervention for cancer patients:
A systematic review (using PRISMA 2020 and Cochrane standards) to synthesize evidence on PTG interventions.
A cross-sectional study (n = 210-240; breast, colorectal, and head \& neck cancer) to examine associations among PTG, QoL, biological markers (e.g., cortisol), illness perceptions, distress, anxiety, and depression.
A randomized controlled trial (RCT) across two centers in Greece (AHEPA University General Hospital and Theageneio Cancer Hospital), comparing a manualized group-based PTG intervention (6-8 weekly sessions, 90 minutes each) with standard care in three cancer populations (70-80 participants per cancer type, randomized into intervention vs. control arms).
Health Policy and Best Practice Development - Using findings from the studies, patient and clinician feedback, and comparisons of national and European oncology guidelines to create evidence-based recommendations for integrating psychosocial interventions into Greek oncology care.
Intervention The PTG intervention will be delivered in groups of 8-10 participants with the same cancer type, facilitated by trained health psychologists. The manual integrates evidence-based therapeutic approaches, including cognitive processing techniques, psychoeducation, cognitive-behavioral elements (e.g., restructuring core beliefs), mindfulness, narrative and existential exercises (e.g., life review, meaning-making), and interpersonal support-building. Sessions are designed to promote growth across PTG's five domains (perception of self, relationships with others, new possibilities, spiritual change, and life appreciation). The intervention's duration is 6-8 weeks, with weekly 90-minute sessions.
Outcomes The primary outcome is PTG, measured via the Post-Traumatic Growth Inventory (PTGI).
Secondary outcomes include:
Quality of life and spiritual well-being (FACIT-Sp and cancer-type specific FACT scales),
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS),
Illness perceptions (Brief Illness Perception Questionnaire, BIPQ),
Distress and trauma impact (Impact of Event Scale-Revised, IES-R),
Biomarkers (cortisol levels as a stress indicator).
Assessments will occur at baseline (pre-intervention) and post-intervention for both control and intervention groups.
Participants Eligible participants are adults (≥18 years) with a diagnosis of breast, colorectal, or head \& neck cancer, who have completed planned chemotherapy and hospitalizations, and whose initial diagnosis occurred within the last five years. Exclusion criteria include active psychological or psychiatric treatment, unmanaged mental health conditions, severe cognitive impairment, inability to provide informed consent, non-Greek speakers, cancer relapse(s), diagnosis of another cancer within five years, or life expectancy under one year.
Analysis Statistical analyses will include Pearson and Spearman correlations, factor analysis, network analysis (for cross-sectional findings), and mixed ANOVA/ANCOVA for RCT outcomes. Reliability (Cronbach's alpha) will be assessed for all questionnaires. Qualitative thematic analysis will be used for feedback from participants and professionals to inform feasibility and implementation strategies.
Impact IC-Growth will generate the first manualized PTG intervention in Greece and one of the first RCTs internationally to evaluate PTG across multiple cancer types. Findings will inform the creation of evidence-based best practice and policy recommendations for psychosocial support in oncology care, disseminated via professional associations, a dedicated national conference, and peer-reviewed publications.
- Conditions
- Breast Cancer, Colon Cancer, Head and Neck Cancers
- Being tested
- IC-Growth ACT-Based Support Program
- Keywords
- Post-Traumatic Growth (PTG), Cancer Survivorship, Psychosocial Intervention, Acceptance and Commitment Therapy (ACT), Quality of Life (QoL), Biomarkers (Cortisol, CRP), Randomized Controlled Trial (RCT, Oncology Supportive Care, Group Therapy, Breast Cancer, Head and Neck Cancer, Colorectal Cancer
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Head and Neck Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC-Growth ACT-Based Support ProgramBehavioural
Also called Experimental, 1
IC-Growth Psychosocial Group Intervention is a structured, manualized program designed to enhance post-traumatic growth (PTG) in adults diagnosed with breast, colorectal, or head and neck cancer. The intervention is delivered in small groups (8-10 participants) over 6-8 weeks, with weekly 90-minute sessions led by trained health psychologists. The program integrates evidence-based therapeutic approaches, including Acceptance and Commitment Therapy (ACT), mindfulness, cognitive restructuring, narrative exercises, and interpersonal support-building, with the goal of improving psychological flexibility, resilience, quality of life, and overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| 1. Group-Based Post-Traumatic Growth (PTG) Intervention | Experimental | Participants receive a manualized, group-based psychosocial intervention designed to enhance post-traumatic growth (PTG). The program is delivered over 6-8 weeks, with weekly 90-minute sessions, and incorporates evidence-based techniques (e.g., Acceptance and Commitment Therapy, mindfulness, cognitive and narrative exercises, and interpersonal support). Receives: Behavioral: IC-Growth ACT-Based Support Program |
| 2. Standard Care (Usual Oncology Follow-Up) | No intervention | Participants receive standard oncology follow-up care with no additional psychosocial intervention. They will complete the same assessments as the intervention group at baseline and post-intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Growth (PTG)
PTG will be assessed using the Post-Traumatic Growth Inventory (PTGI), a validated 21-item self-report questionnaire measuring positive psychological change following trauma. Higher scores indicate greater post-traumatic growth.
Measured: Baseline and post-intervention (6-8 weeks)
Secondary outcomes (5)
Anxiety and Depression
Baseline and post-intervention (6-8 weeks)
Measured: Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item validated self-report tool. Higher scores indicate greater levels of anxiety and depression.
Quality of Life and Spiritual Well-being
Measured using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp) and cancer-type specific scales (e.g., FACT-B, FACT-H\&N, FACT-C). Higher scores reflect better perceived quality of life and spiritual well-being.
Measured: Baseline and post-intervention (6-8 weeks)
Distress Related to Traumatic Events
Measured using the Impact of Event Scale-Revised (IES-R), a 22-item self-report instrument assessing subjective distress related to a specific traumatic event. Higher scores indicate greater distress.
Measured: Baseline and post-intervention (6-8 weeks)
Illness Perceptions
Assessed using the Brief Illness Perceptions Questionnaire (BIPQ), which measures cognitive and emotional representations of illness. Higher scores on relevant subscales indicate more negative or threatening illness perceptions.
Measured: Baseline and post-intervention (6-8 weeks)
Salivary Cortisol Levels
Cortisol levels will be measured from saliva samples collected as a biomarker of physiological stress. Lower post-intervention cortisol levels may indicate reduced stress and improved endocrine regulation.
Measured: Baseline and post-intervention (6-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 May 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Research and Technology Hellas
- Sponsor type
- University, hospital or other
- Collaborators
- AHEPA University Hospital, Hellenic Cancer Society, Theagenio Cancer Hospital
- Responsible party
- Principal investigator, Christina Karamanidou, Centre for Research and Technology Hellas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108517
- Sponsor's protocol ID
- ELIDEK_KARAMANIDOU
- Acronym
- IC-Growth
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Manualized Post-Traumatic Growth Intervention for People With Cancer in Greece - IC-Growth. The Overarching Aim of IC-Growth is to Promote Psychosocial Care and Support for People With Cancer Using Acceptance and Committment Therapy.
- ClinicalTrials.gov ID
- NCT07108517
- Acronym / sponsor ID
- IC-Growth / ELIDEK_KARAMANIDOU
- Conditions
- Breast Cancer, Colon Cancer, Head and Neck Cancers
- Keywords
- Post-Traumatic Growth (PTG), Cancer Survivorship, Psychosocial Intervention, Acceptance and Commitment Therapy (ACT), Quality of Life (QoL), Biomarkers (Cortisol, CRP), Randomized Controlled Trial (RCT, Oncology Supportive Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre for Research and Technology HellasUniversity, hospital or other
- Collaborators
- AHEPA University Hospital, Hellenic Cancer Society, Theagenio Cancer Hospital
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Aug 2025 (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.
Cancer can be a very traumatic experience for the people affected and the majority of the psychological literature focuses on this. Less proliferated and researched is the increasingly recognized fact that as a result of struggling with such traumatic adversities, some people experience what is known as post-traumatic growth (PTG). PTG not only allows them to overcome their trauma (e.g., impact of cancer) and return to pre-diagnosis functioning (e.g., health, wellbeing, employment) but also results in them going over and above their previous state (e.g., increased resilience). This renders PTG an important phenomenon that could be enhanced as part of the support people with cancer receive. IC-Growth has two interconnected paths, namely a research one and another of health policy and best practice recommendations. On the first path, is a sequence of three studies, starting with a systematic review, followed by a cross-sectional study and concludes with a randomized control trial (RCT). The systematic review and close collaboration with experts (e.g., patient associations) will lead to the development of a novel manual to facilitate PTG in groups of people with cancer. The cross-sectional study will explore relationships between variables (e.g., PTG, quality of life, biological variables, illness perceptions, distress, anxiety, depression) in people with cancer (n = 150-180). Lastly, the RCT will evaluate the intervention's effects among three different groups (breast, colorectal, and head and neck cancers, n = 50-60 per group). On the other path, is the development of health policy and best practice recommendations regarding the psychosocial support of people with cancer in Greece. The project's results will be disseminated to stakeholders who provide support to people with cancer (e.g., oncologists, surgeons, psychologists, psychiatrists), through professional associations, a conference on "Psychosocial Support in Oncology", and publications in scientific journals. Overall, IC-Growth is a multidisciplinary project (i.e., psychology, medical, patient organizations, health policy) and joins the clinical, research and policy fields together to workable actions leading to empowering the wider community of people with cancer and improving their care.
Detailed description
Detailed Description IC-Growth is a 24-month, multidisciplinary research and clinical project aimed at enhancing psychosocial care for adults with cancer by promoting post-traumatic growth (PTG)-positive psychological changes following traumatic life crises. While most research emphasizes the negative psychological effects of cancer, IC-Growth focuses on understanding and facilitating PTG as a mechanism to improve well-being, resilience, and quality of life (QoL) beyond pre-diagnosis levels.
The project has two interconnected components:
Research - A sequence of three studies to build, test, and evaluate a novel, manualized PTG intervention for cancer patients:
A systematic review (using PRISMA 2020 and Cochrane standards) to synthesize evidence on PTG interventions.
A cross-sectional study (n = 210-240; breast, colorectal, and head \& neck cancer) to examine associations among PTG, QoL, biological markers (e.g., cortisol), illness perceptions, distress, anxiety, and depression.
A randomized controlled trial (RCT) across two centers in Greece (AHEPA University General Hospital and Theageneio Cancer Hospital), comparing a manualized group-based PTG intervention (6-8 weekly sessions, 90 minutes each) with standard care in three cancer populations (70-80 participants per cancer type, randomized into intervention vs. control arms).
Health Policy and Best Practice Development - Using findings from the studies, patient and clinician feedback, and comparisons of national and European oncology guidelines to create evidence-based recommendations for integrating psychosocial interventions into Greek oncology care.
Intervention The PTG intervention will be delivered in groups of 8-10 participants with the same cancer type, facilitated by trained health psychologists. The manual integrates evidence-based therapeutic approaches, including cognitive processing techniques, psychoeducation, cognitive-behavioral elements (e.g., restructuring core beliefs), mindfulness, narrative and existential exercises (e.g., life review, meaning-making), and interpersonal support-building. Sessions are designed to promote growth across PTG's five domains (perception of self, relationships with others, new possibilities, spiritual change, and life appreciation). The intervention's duration is 6-8 weeks, with weekly 90-minute sessions.
Outcomes The primary outcome is PTG, measured via the Post-Traumatic Growth Inventory (PTGI).
Secondary outcomes include:
Quality of life and spiritual well-being (FACIT-Sp and cancer-type specific FACT scales),
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS),
Illness perceptions (Brief Illness Perception Questionnaire, BIPQ),
Distress and trauma impact (Impact of Event Scale-Revised, IES-R),
Biomarkers (cortisol levels as a stress indicator).
Assessments will occur at baseline (pre-intervention) and post-intervention for both control and intervention groups.
Participants Eligible participants are adults (≥18 years) with a diagnosis of breast, colorectal, or head \& neck cancer, who have completed planned chemotherapy and hospitalizations, and whose initial diagnosis occurred within the last five years. Exclusion criteria include active psychological or psychiatric treatment, unmanaged mental health conditions, severe cognitive impairment, inability to provide informed consent, non-Greek speakers, cancer relapse(s), diagnosis of another cancer within five years, or life expectancy under one year.
Analysis Statistical analyses will include Pearson and Spearman correlations, factor analysis, network analysis (for cross-sectional findings), and mixed ANOVA/ANCOVA for RCT outcomes. Reliability (Cronbach's alpha) will be assessed for all questionnaires. Qualitative thematic analysis will be used for feedback from participants and professionals to inform feasibility and implementation strategies.
Impact IC-Growth will generate the first manualized PTG intervention in Greece and one of the first RCTs internationally to evaluate PTG across multiple cancer types. Findings will inform the creation of evidence-based best practice and policy recommendations for psychosocial support in oncology care, disseminated via professional associations, a dedicated national conference, and peer-reviewed publications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Group-Based Post-Traumatic Growth (PTG) Intervention | Experimental | Behavioral: IC-Growth ACT-Based Support ProgramParticipants receive a manualized, group-based psychosocial intervention designed to enhance post-traumatic growth (PTG). The program is delivered over 6-8 weeks, with weekly 90-minute sessions, and incorporates evidence-based techniques (e.g., Acceptance and Commitment Therapy, mindfulness, cognitive and narrative exercises, and interpersonal support). |
| 2. Standard Care (Usual Oncology Follow-Up) | No intervention | –Participants receive standard oncology follow-up care with no additional psychosocial intervention. They will complete the same assessments as the intervention group at baseline and post-intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥ 18 years)
- Having a diagnosis of a. Breast Cancer, b. Colorectal Cancer, or c. Head and Neck Cancer.
- Having concluded the planned chemotherapy courses and related hospital admissions
- Having no more than 5 years since the initial diagnosis.
Key exclusion criteria (8 listed)
- Being in active psychological or psychiatric treatment
- Having an unmanaged mental health difficulty
- Having a severe cognitive impairment
- Being unable to give informed consent
- Being unable to speak or read Greek
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 |
|---|---|---|
| IC-Growth ACT-Based Support ProgramAlso: Experimental, 1IC-Growth Psychosocial Group Intervention is a structured, manualized program designed to enhance post-traumatic growth (PTG) in adults diagnosed with breast, colorectal, or head and neck cancer. The intervention is delivered in small groups (8-10 participants) over 6-8 weeks, with weekly 90-minute sessions led by trained health psychologists. The program integrates evidence-based therapeutic approaches, including Acceptance and Commitment Therapy (ACT), mindfulness, cognitive restructuring, narrative exercises, and interpersonal support-building, with the goal of improving psychological flexibility, resilience, quality of life, and overall well-being. | Behavioural | 1. Group-Based Post-Traumatic Growth (PTG) Intervention |
Primary outcome
Post-Traumatic Growth (PTG)
Time frame: Baseline and post-intervention (6-8 weeks)
PTG will be assessed using the Post-Traumatic Growth Inventory (PTGI), a validated 21-item self-report questionnaire measuring positive psychological change following trauma. Higher scores indicate greater post-traumatic growth.
5 secondary outcomes
Anxiety and Depression
Time frame: Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item validated self-report tool. Higher scores indicate greater levels of anxiety and depression.
Quality of Life and Spiritual Well-being
Time frame: Baseline and post-intervention (6-8 weeks)
Distress Related to Traumatic Events
Time frame: Baseline and post-intervention (6-8 weeks)
Illness Perceptions
Time frame: Baseline and post-intervention (6-8 weeks)
Salivary Cortisol Levels
Time frame: Baseline and post-intervention (6-8 weeks)
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 7 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IC-Growth ACT-Based Support Program in people with Breast Cancer and Colon Cancer, run by Centre for Research and Technology Hellas at 1 site in Greece.
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 4 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Traumatic Growth (PTG) (time frame: Baseline and post-intervention (6-8 weeks)). 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 7 Aug 2025.