Breast CancerOPTIMUNENCT03448250
Evaluating a Novel Web-based Intervention for Breast Cancer Survivors
A study testing Optimune and Care-As-Usual in people with Breast Cancer, run by Technical University of Dortmund at 2 sites in Germany.
Trial summary
The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast cancer who are past the active eradication phase and free from disease recurrence. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Optimune and Care-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesGermany
- Study dates
- 16 Mar 2018to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible are women who
- had breast cancer diagnosed less than 4 years ago, classified as T0-4, N0-1, M0
- completed acute treatment for breast cancer at least 6 month ago. This applies for surgery, chemotherapy or radiation, whichever occurred last. (Prophylactic treatment with anti-hormones like tamoxifen, aromatase-inhibitors or bisphosphonates is allowed).
- are competent in German language
- provide written consent to study procedures
- are willing to provide the discharge letter from oncology (to verify diagnosis and therapies)
Who cannot join
- Women are not eligible if they
- have a prior history of breast cancer (other than the current one) or any other cancer except basal or squamous cell skin cancer
- suffer from the following autoimmune and/or inflammatory diseases: rheumatoid arthritis, lupus erythematodes, psoriasis, multiple sclerosis or inflammatory breast cancer
- have a history of schizophrenia, bipolar disorder, or an established diagnosis of borderline personality disorder
- have elevated current suicide risk
- routinely attend psychotherapy, either 1:1, group-therapy or web-based interaction (at least two sessions per month)
Show all 9Show fewer
- practice 5 hours or more of vigorous physical activity per week (e.g. training for marathon)
- have cognitive impairment
- abuse alcohol or drugs
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors
Dortmund, 44139
University Medical Center Leipzig, Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology
Leipzig, 04103
About this study
Official title: Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Immune Status, Inflammation and Psychometric Outcome
The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast cancer who are past the active eradication phase and free from disease recurrence. The present study will test the hypothesis that Optimune has an impact on immune status, markers of inflammation and psychometric outcomes. Therefore, 150 woman with breast cancer will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment (Care-as-Usual, CAU) and receive access to Optimune after a delay of 6 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Optimune and may also use CAU. The primary outcome measure is the effect on inflammatory parameters six month post-baseline.
Read the detailed description
Depression and fatigue is common in breast cancer survivors and its presence is associated with personal suffering, increased inflammatory activity, and worse prognosis. While in the phase of acute treatment many women receive short-term psychological support to better cope with the situation, this is not standard of care in the years following. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective. However, no trial has yet examined whether a CBT-based internet intervention designed to meet the needs of breast cancer survivors can achieve effects on immune status, inflammation and psychometric outcomes, when offered as adjunct to care as usual.
In this study, the investigators will study treatment effects of the novel web-based program Optimune when added to treatment as usual. Beyond established CBT techniques targeting depression, anxiety, and fatigue, this intervention specifically includes elements that have shown effects on markers of immune status and inflammation, including sleep and stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). The delivery and training of content is continuously individualized to match users' preferences and needs, based on responses within the program. The intervention is delivered via the internet and protected by individually assigned passwords. The program can be accessed for 365 days after registration.
This randomized controlled trial will include 150 women with breast cancer who are past the active eradication phase and free from disease recurrence. Participants will be recruited from various settings, including web-based advertisement and internet forums/groups. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to the web-based intervention (Optimune) after a delay of 6 months (i.e., CAU/wait list control group), or (2) a treatment group that may also use CAU and in addition immediately receives 12-month access to the web-based intervention (Optimune). Measurements are collected at pre-treatment (T0) three months (T1), six months (T2), nine months (T3) and twelve months (T4).
- Conditions
- Breast Cancer
- Being tested
- Optimune, Care-As-Usual
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptimuneBehavioural
Optimune is a web-based psychological intervention developed for women with breast cancer.
Care-As-UsualOther
Participants are free to continue to engage with any treatment they require (i.e., CAU).
| Study group | Role | What they receive |
|---|---|---|
| Optimune | Experimental | Optimune is an web-based psychological intervention for women with breast cancer. Beyond established CBT techniques targeting depression, anxiety, and fatigue, this intervention specifically includes elements that have shown effects on markers of immune status and inflammation, including sleep, stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). Content is continuously adapted to users' concerns and needs. It contains interactive dialogues that can be accessed via computer or smart-phone, illustrations, audio files and motivating text messages. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration. Receives: Behavioral: Optimune |
| Care-as-Usual | Active comparator | As in the experimental arm, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Optimune six months post-baseline (i.e., wait list with respect to Optimune access). Receives: Other: Care-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of C-reactive protein (CRP)
Plasma concentration of C-reactive protein (CRP)
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
circulating Interleukin (IL) 6
Plasma concentration of IL-6
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
circulating Tumor necrosis factor (TNF)-α
Plasma concentration of TNF-α
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
stimulated IL-6
Concentration of secreted IL-6 after stimulation of peripheral blood mononuclear cells with Lipopolysaccharide (LPS)
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
stimulated TNF-α
Concentration of secreted TNF-α after stimulation of peripheral blood mononuclear cells with Lipopolysaccharide (LPS)
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Secondary outcomes (13)
Plasma Concentrations of Cytokines
Circulating levels (pg/ml) of IL-1β, IFN- α, IFN-γ, MCP-1, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, and IL-33 will be measured using cytometric bead array (CBA)
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted Cytokines after Phorbol-12-myristate-13-acetate (PMA) stimulation of peripheral blood mononuclear cells
Concentrations (pg/ml) of secreted of IL-1β, Interferon (IFN)-α, IFN-γ, TNF-α, MCP-1, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, and IL-33 after stimulation of peripheral blood mononuclear cells with Phorbol-12-myristate-13-acetate (PMA) will be measured using a cytometric bead array (CBA).
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted Cytokines after Lipopolysaccharide (LPS) Stimulation of peripheral blood mononuclear cells
Concentrations (pg/ml) of secreted of IL-1β, IFN- α, IFN-γ, TNF- α, MCP-1, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, and IL-33 after stimulation of peripheral blood mononuclear cells with LPS will be measured using cytometric bead array (CBA)
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Circulating numbers of Lymphocytes, Monocytes, Granulocytes
Circulating numbers of Lymphocytes, Monocytes, and Granulocytes (per ul blood) will be measured by 'TruCount' Flow Cytometry.
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Phenotypic analysis of T and NK cell subsets
We will analyze the distribution of T cell and NK cell subsets by 11 color Flow Cytometry (using the following antibody panels:
Panel 1 ("NK + T cells + Treg + memory + homing"): KLRG1, CD3, Zombie Yellow, CD8, CD28, CD57, CD56, CD62L, CD197, CD45RA, CD4.
Panel 2 ("NK + T activation + memory"): KLRG1, CD3, Zombie Yellow, NKG2C, CD56, CD57, CD25, DNAM-1, CD69.
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Cortisol awakening response (CAR)
Cortisol concentrations from saliva samples taken at time of awakening and 30 and 45 min. after awakening will be measured to determine the Cortisol awakening response (CAR)
Measured: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Determination of cancer-related fatigue using the Brief Fatigue Inventory Questionnaire
Fatigue will be measured using the Brief Fatigue Inventory Questionnaire (BFI-9) questionnaire. Scale Range: 0 to 90.
The BFI is a 9-item, 11-point rating scale. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Interpretation: A global fatigue score can be obtained by averaging all the items on the BFI.
Higher scores on the BFI correspond to greater self-reported levels of fatigue
Measured: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of cancer-related emotional stress
Cancer-related emotional stress will be measured using the standardized IES-R (Impact of Event Scale) Questionnaire. Scale Range: 0 to 88 The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
Interpretation: Higher scores correspond to greater self-reported levels of post-traumatic stress.
Measured: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of depression
Depression will be measured using the standardized PHQ-9 (Patient Health Questionnaire). Scale Range: 0 to 27 The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
Interpretation: Higher scores correspond to greater self-reported levels of depression.
Measured: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of anxiety
Anxiety will be measured using the standardized GAD-7 (Generalized Anxiety Disorder) questionnaire. Scale Range: 0 to 21 The GAD-7 is an instrument for screening, diagnosing, monitoring and measuring the severity of anxiety. GAD-7 scores of 5, 10, and 15 represents mild, moderate, and severe anxiety.
Interpretation: Higher scores correspond to greater self-reported levels of anxiety.
Measured: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of fear of progression
Fear of progression will be measured using the standardized PA-F12 (Fear of progression) questionnaire. Scale Range: 12 - 60 The PAF-12 items are scored on a five-point Likert Scale ranging from 1 ('never') to 5 ('very often'), higher values indicating higher levels of anxiety.
Interpretation: Higher scores correspond to greater self-reported levels of fear of progression.
Measured: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of usefulness of the program
Usefulness of the program will be measured by a questionnaire
Measured: Assessed at 3, 6, 9 and 12 months
Determination of Negative Effects
Negative Effects will be measured using the standardized INEP (Inventory for the Assessment of Negative Effects of Psychotherapy) questionnaire.
Measured: Assessed at 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start16 Mar 2018
- Primary completion30 Sep 2021
- Study completion30 Apr 2022
Why it stopped: Participant recruitment was stopped due to corona pandemic.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Dortmund
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Gaia AG
- Responsible party
- Principal investigator, Carsten Watzl, Technical University of Dortmund
- Investigators
- Carsten Watzl, PhD, Principal investigator, Leibniz Research Center (IfADo), TU Dortmund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448250
- Sponsor's protocol ID
- Optimune Trial
- Acronym
- OPTIMUNE
- Status last verified
- Apr 2022
- First submitted
- 7 Feb 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Immune Status, Inflammation and Psychometric Outcome
- ClinicalTrials.gov ID
- NCT03448250
- Acronym / sponsor ID
- OPTIMUNE / Optimune Trial
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant recruitment was stopped due to corona pandemic.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Technical University of DortmundUniversity, hospital or other
- Collaborators
- University of Leipzig, Gaia AG
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 28 Feb 2018 (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 trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast cancer who are past the active eradication phase and free from disease recurrence. The present study will test the hypothesis that Optimune has an impact on immune status, markers of inflammation and psychometric outcomes. Therefore, 150 woman with breast cancer will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment (Care-as-Usual, CAU) and receive access to Optimune after a delay of 6 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Optimune and may also use CAU. The primary outcome measure is the effect on inflammatory parameters six month post-baseline.
Detailed description
Depression and fatigue is common in breast cancer survivors and its presence is associated with personal suffering, increased inflammatory activity, and worse prognosis. While in the phase of acute treatment many women receive short-term psychological support to better cope with the situation, this is not standard of care in the years following. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective. However, no trial has yet examined whether a CBT-based internet intervention designed to meet the needs of breast cancer survivors can achieve effects on immune status, inflammation and psychometric outcomes, when offered as adjunct to care as usual.
In this study, the investigators will study treatment effects of the novel web-based program Optimune when added to treatment as usual. Beyond established CBT techniques targeting depression, anxiety, and fatigue, this intervention specifically includes elements that have shown effects on markers of immune status and inflammation, including sleep and stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). The delivery and training of content is continuously individualized to match users' preferences and needs, based on responses within the program. The intervention is delivered via the internet and protected by individually assigned passwords. The program can be accessed for 365 days after registration.
This randomized controlled trial will include 150 women with breast cancer who are past the active eradication phase and free from disease recurrence. Participants will be recruited from various settings, including web-based advertisement and internet forums/groups. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to the web-based intervention (Optimune) after a delay of 6 months (i.e., CAU/wait list control group), or (2) a treatment group that may also use CAU and in addition immediately receives 12-month access to the web-based intervention (Optimune). Measurements are collected at pre-treatment (T0) three months (T1), six months (T2), nine months (T3) and twelve months (T4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimune | Experimental | Behavioral: OptimuneOptimune is an web-based psychological intervention for women with breast cancer. Beyond established CBT techniques targeting depression, anxiety, and fatigue, this intervention specifically includes elements that have shown effects on markers of immune status and inflammation, including sleep, stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). Content is continuously adapted to users' concerns and needs. It contains interactive dialogues that can be accessed via computer or smart-phone, illustrations, audio files and motivating text messages. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration. |
| Care-as-Usual | Active comparator | Other: Care-As-UsualAs in the experimental arm, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Optimune six months post-baseline (i.e., wait list with respect to Optimune access). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible are women who
- had breast cancer diagnosed less than 4 years ago, classified as T0-4, N0-1, M0
- completed acute treatment for breast cancer at least 6 month ago. This applies for surgery, chemotherapy or radiation, whichever occurred last. (Prophylactic treatment with anti-hormones like tamoxifen, aromatase-inhibitors or bisphosphonates is allowed).
- are competent in German language
- provide written consent to study procedures
Key exclusion criteria (9 listed)
- Women are not eligible if they
- have a prior history of breast cancer (other than the current one) or any other cancer except basal or squamous cell skin cancer
- suffer from the following autoimmune and/or inflammatory diseases: rheumatoid arthritis, lupus erythematodes, psoriasis, multiple sclerosis or inflammatory breast cancer
- have a history of schizophrenia, bipolar disorder, or an established diagnosis of borderline personality disorder
- have elevated current suicide risk
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 |
|---|---|---|
| OptimuneOptimune is a web-based psychological intervention developed for women with breast cancer. | Behavioural | Optimune |
| Care-As-UsualParticipants are free to continue to engage with any treatment they require (i.e., CAU). | Other | Care-as-Usual |
Primary outcome
concentration of C-reactive protein (CRP)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Plasma concentration of C-reactive protein (CRP)
circulating Interleukin (IL) 6
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Plasma concentration of IL-6
circulating Tumor necrosis factor (TNF)-α
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Plasma concentration of TNF-α
stimulated IL-6
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted IL-6 after stimulation of peripheral blood mononuclear cells with Lipopolysaccharide (LPS)
stimulated TNF-α
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted TNF-α after stimulation of peripheral blood mononuclear cells with Lipopolysaccharide (LPS)
13 secondary outcomes
Plasma Concentrations of Cytokines
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted Cytokines after Phorbol-12-myristate-13-acetate (PMA) stimulation of peripheral blood mononuclear cells
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted Cytokines after Lipopolysaccharide (LPS) Stimulation of peripheral blood mononuclear cells
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Circulating numbers of Lymphocytes, Monocytes, Granulocytes
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Phenotypic analysis of T and NK cell subsets
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Cortisol awakening response (CAR)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Determination of cancer-related fatigue using the Brief Fatigue Inventory Questionnaire
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of cancer-related emotional stress
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of depression
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of anxiety
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of fear of progression
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of usefulness of the program
Time frame: Assessed at 3, 6, 9 and 12 months
Determination of Negative Effects
Time frame: Assessed at 3, 6, 9 and 12 months
Results and safety
The study was stopped early (reason given: Participant recruitment was stopped due to corona pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Watzl, PhD principal investigator
Leibniz Research Center (IfADo), TU Dortmund
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimune and Care-As-Usual in people with Breast Cancer, run by Technical University of Dortmund at 2 sites in Germany.
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 9 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: stopped early, as of the sponsor's last update on 5 May 2022. 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 Germany. 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?
The study was stopped early (reason given: Participant recruitment was stopped due to corona pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of C-reactive protein (CRP) (time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)). The study lists 5 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 5 May 2022.