Female Breast Cancer PatientsVIT-BCNCT07357207
Video-immunotherapy: a New Approach in Breast Cancer Treatment
A study testing UMAY - Video-immunotherapy game in people with Female Breast Cancer Patients, run by Izmir Biomedicine and Genome Center at 3 sites in Turkey (Türkiye).
Trial summary
Breast cancer is the most common type of cancer among women worldwide and in Türkiye and remains one of the leading causes of cancer-related mortality. The high mortality rate and the fact that the disease severely reduces patients' quality of life create an urgent need for the development of innovative therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Breast Cancer Patients
- What is being tested?
- UMAY - Video-immunotherapy game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 2 Feb 2027
- 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
Who may be able to join
- having locally advanced breast cancer
- To be over 18 years old
- Volunteering to participate in the study
- ECOG performance score of 0-1
- To be able to communicate in Turkish
- Obtaining written informed consent for participation in the study
Who cannot join
- History of epilepsy and similar seizures
- History of cognitive impairment such as dementia, Alzheimer's disease
- Major depression or suicidal tendencies
- Traumatic brain injury
- Lack of sight, hearing or use of hands
- Previous history of cancer other than breast cancer
Show all 9Show fewer
- Chronic use of immunosuppressive drugs (e.g. steroids)
- Active immunodeficiency
- Having any disability to play video games
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites
Akdeniz University Hospital
Antalya, Konyaaltı, 07070
Antalya Training and Research Hospital
Antalya, Muratpasa, 07100
Dokuz Eylul University Hospital
Izmir, Balcova, 35340
About this study
Breast cancer is the most common type of cancer among women worldwide and in Türkiye and remains one of the leading causes of cancer-related mortality. The high mortality rate and the fact that the disease severely reduces patients' quality of life create an urgent need for the development of innovative therapeutic approaches. Cancer immunotherapy aims to inhibit tumor growth and spread by harnessing the immune system. The fact that the immune system interacts with the nervous system and the endocrine system reveals that the integrity of the body and mind is very important in strengthening the immune system against cancer. Within the scope of psychoneuroimmunology, studies such as meditation, breathing therapy, hypnosis, and yoga have an indirect effect on the immune system by reducing the stress level of the person and improving the psychology, while techniques such as guided imagery can play a direct role in regulating the immune system. It has been shown that guided imagery studies, which can create unexpected effects thanks to the inability of the human mind to distinguish between imagination and reality, can increase the activity of immune cells with anti-tumoral activity in cancer patients and even reduce patient mortality. In addition to the cytotoxic activities of immune system cells, imagery can also have an effect on the regulation of tissue migration. Therefore, guided imagery studies in breast cancer patients can contribute both to immune system regulation and to increase lymphocyte migration to the tumor tissue of patients if they are applied effectively and long-term enough. In guided imagery studies, it is thought that the effectiveness is limited by the stress experienced by the patients/subjects during the effort of practicing imagery. In addition, imagery vividness also plays a decisive role in the effectiveness. In this study, the investigators developed a video game in which immune cells fight breast cancer cells, and through this video game, patients will be able to easily, actively, and vividly visualize their immune cells destroying the cancer. In the meantime, instead of being stressed, the patients will be playing games and having fun with imagery. Thus, the investigators developed a unique guided imagery complementary therapy called video-immunotherapy in the treatment of breast cancer. It is predicted that the immune system of the person playing the video game would be stimulated to exert an anti-tumoral effect. In this study, breast cancer patients will play the video immunotherapy or a control placebo video game in addition to their current treatment (neoadjuvant chemotherapy). The effect of the video immunotherapy on the course of the disease, physiological symptoms, and psychological well-being of the patients will be measured, and the effect of the game on the immune cells of the patients will be analyzed in detail.
- Conditions
- Female Breast Cancer Patients
- Being tested
- UMAY - Video-immunotherapy game, Control - Plasebo Game
- Keywords
- video-immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMAY - Video-immunotherapy gameBehavioural
"UMAY" video-immunotherapy about immune cells fighting breast cancer - participants will play the UMAY video game offered as a mobile phone app at home for at least 20 minutes at least 4 days a week.
Control - Plasebo GameBehavioural
participants will play the placebo video game as a mobile phone app at home for at least 20 minutes at least 4 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Video-immunotherapy group | Experimental | EXPERIMENT GROUP: will play the "video-immunotherapy" about immune cells fighting breast cancer. Receives: Behavioral: UMAY - Video-immunotherapy game |
| Control group | Placebo comparator | CONTROL GROUP: the placebo video game. Receives: Behavioral: Control - Plasebo Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Depression Anxiety Stress Scale (DASS-42) total score
The Depression Anxiety Stress Scale (DASS-42) is a self-reported questionnaire designed to measure negative emotional states across three subscales: depression, anxiety, and stress. The total score is calculated by summing all 42 items.
Minimum value: 0 Maximum value: 126 (42 items × 0-3 Likert scale)
Score interpretation: Higher scores indicate worse psychological distress.
Measured: Experimental and control group patients will answer questionnaires to monitor their psychological status and physiological symptoms 3 times in total: baseline (month 0), during the treatment (month 3) and at the end of treatment (month 5-6).
Change from baseline in Edmonton Symptom Assessment System-revised (ESAS-r) total symptom score
The Edmonton Symptom Assessment System-revised (ESAS-r) is a patient-reported outcome measure assessing the severity of common cancer-related symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and an optional additional symptom. Each symptom is rated on a numeric scale.
Minimum value: 0 Maximum value: 100 (10 symptoms × 0-10 numeric rating scale)
Score interpretation: Higher scores indicate worse symptom burden.
Measured: Baseline (Month 0), during treatment (Month 3), and end of treatment (Month 5-6)
Change from baseline in frequency of immune cell subsets in peripheral blood and tumor tissue
The frequency of immune cell subsets involved in breast cancer immunity will be assessed by flow cytometry. The analyzed cell populations include CD4⁺ T cells, CD8⁺ T cells, regulatory T cells (Treg), NK cells, monocytes in peripheral blood and tumor tissue, and myeloid-derived suppressor cells, as well as M1 and M2 macrophages in tumor tissue only. Cell frequencies will be reported as a percentage of CD45⁺ live cells.
Unit of Measure: Percentage (%)
Measured: Peripheral blood: Baseline (Month 0) and end of treatment (Month 5-6) Tumor tissue: End of treatment (Month 5-6)
Change from baseline in activation marker expression on immune cell subsets
Activation status of immune cells will be evaluated by flow cytometry based on the expression of activation markers. NK cells and T cell subsets will be assessed using CD25, CD69, and HLADR expression, while monocytes and macrophages will be assessed using CD86 and HLADR expression. Activation will be reported as median fluorescence intensity (MFI).
Unit of Measure: Median fluorescence intensity (MFI)
Measured: Peripheral blood: Baseline (Month 0) and end of treatment (Month 5-6) Tumor tissue: End of treatment (Month 5-6)
Change from baseline in tumor size measured by ultrasound and mammography for the assessment of the effects on disease progression
Tumor size will be assessed using standard clinical imaging methods, including ultrasound and mammography, to evaluate disease progression in patients receiving the UMAY video-immunotherapy or placebo control intervention.
Tumor size will be recorded as the largest tumor diameter (in millimeters), according to routine clinical assessment.
Unit of Measure: Millimeters (mm)
Measured: Baseline (Month 0), mid-treatment (Month 3), and end of treatment (Month 5-6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Dec 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast Cancer PatientsStudies 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
- Model description
- In this study, locally advanced breast cancer patients who received neoadjuvant chemotherapy as routine treatment for 5-6 months will be randomized into 2 groups: EXPERIMENT GROUP: will play the "video-immunotherapy" about immune cells fighting breast cancer (n=40). CONTROL GROUP: Will play the placebo video game (n=40). The study will be terminated at the end of 5-6 months when the patients undergo surgery as a normal treatment process.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Biomedicine and Genome Center
- Sponsor type
- Other government
- Collaborators
- Antalya Training and Research Hospital, Akdeniz University Hospital, Dokuz Eylul University
- Responsible party
- Principal investigator, Duygu Sag, Izmir Biomedicine and Genome Center
- Investigators
- Duygu Sag, Ph.D., Principal investigator, Izmir Biomedicine and Genome Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357207
- Sponsor's protocol ID
- iBG-2022-017
- Other IDs
- 121C245
- Acronym
- VIT-BC
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified IPD through controlled access after publication. Shared variables will include DASS and ESAS scores at baseline, mid-treatment and end-of-treatment; tumor size by ultrasound/mammography at the same time points; and flow-cytometry profiles of CD4+, CD8+, Treg, NK cells, monocytic cells from blood (baseline and month 5-6) and tumor tissue (month 5-6). All data will be anonymized and no direct identifiers will be released. Access will require ethics approval and a data-use agreement. Access will be prioritized for investigators conducting non-commercial research aimed at advancing breast-cancer immunotherapy or improving statistical/clinical reproducibility.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-immunotherapy: a New Approach in Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT07357207
- Acronym / sponsor ID
- VIT-BC / iBG-2022-017
- Conditions
- Female Breast Cancer Patients
- Keywords
- video-immunotherapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Izmir Biomedicine and Genome CenterOther government
- Collaborators
- Antalya Training and Research Hospital, Akdeniz University Hospital, Dokuz Eylul University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 21 Jan 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.
Breast cancer is the most common type of cancer among women worldwide and in Türkiye and remains one of the leading causes of cancer-related mortality. The high mortality rate and the fact that the disease severely reduces patients' quality of life create an urgent need for the development of innovative therapeutic approaches. Cancer immunotherapy aims to inhibit tumor growth and spread by harnessing the immune system. The fact that the immune system interacts with the nervous system and the endocrine system reveals that the integrity of the body and mind is very important in strengthening the immune system against cancer. Within the scope of psychoneuroimmunology, studies such as meditation, breathing therapy, hypnosis, and yoga have an indirect effect on the immune system by reducing the stress level of the person and improving the psychology, while techniques such as guided imagery can play a direct role in regulating the immune system. It has been shown that guided imagery studies, which can create unexpected effects thanks to the inability of the human mind to distinguish between imagination and reality, can increase the activity of immune cells with anti-tumoral activity in cancer patients and even reduce patient mortality. In addition to the cytotoxic activities of immune system cells, imagery can also have an effect on the regulation of tissue migration. Therefore, guided imagery studies in breast cancer patients can contribute both to immune system regulation and to increase lymphocyte migration to the tumor tissue of patients if they are applied effectively and long-term enough. In guided imagery studies, it is thought that the effectiveness is limited by the stress experienced by the patients/subjects during the effort of practicing imagery. In addition, imagery vividness also plays a decisive role in the effectiveness. In this study, the investigators developed a video game in which immune cells fight breast cancer cells, and through this video game, patients will be able to easily, actively, and vividly visualize their immune cells destroying the cancer. In the meantime, instead of being stressed, the patients will be playing games and having fun with imagery. Thus, the investigators developed a unique guided imagery complementary therapy called video-immunotherapy in the treatment of breast cancer. It is predicted that the immune system of the person playing the video game would be stimulated to exert an anti-tumoral effect. In this study, breast cancer patients will play the video immunotherapy or a control placebo video game in addition to their current treatment (neoadjuvant chemotherapy). The effect of the video immunotherapy on the course of the disease, physiological symptoms, and psychological well-being of the patients will be measured, and the effect of the game on the immune cells of the patients will be analyzed in detail.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, locally advanced breast cancer patients who received neoadjuvant chemotherapy as routine treatment for 5-6 months will be randomized into 2 groups: EXPERIMENT GROUP: will play the "video-immunotherapy" about immune cells fighting breast cancer (n=40). CONTROL GROUP: Will play the placebo video game (n=40). The study will be terminated at the end of 5-6 months when the patients undergo surgery as a normal treatment process.
| Arm | Type | Receives |
|---|---|---|
| Video-immunotherapy group | Experimental | Behavioral: UMAY - Video-immunotherapy gameEXPERIMENT GROUP: will play the "video-immunotherapy" about immune cells fighting breast cancer. |
| Control group | Placebo comparator | Behavioral: Control - Plasebo GameCONTROL GROUP: the placebo video game. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- having locally advanced breast cancer
- To be over 18 years old
- Volunteering to participate in the study
- ECOG performance score of 0-1
- To be able to communicate in Turkish
Key exclusion criteria (9 listed)
- History of epilepsy and similar seizures
- History of cognitive impairment such as dementia, Alzheimer's disease
- Major depression or suicidal tendencies
- Traumatic brain injury
- Lack of sight, hearing or use of hands
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 |
|---|---|---|
| UMAY - Video-immunotherapy game"UMAY" video-immunotherapy about immune cells fighting breast cancer - participants will play the UMAY video game offered as a mobile phone app at home for at least 20 minutes at least 4 days a week. | Behavioural | Video-immunotherapy group |
| Control - Plasebo Gameparticipants will play the placebo video game as a mobile phone app at home for at least 20 minutes at least 4 days a week. | Behavioural | Control group |
Primary outcome
Change from baseline in Depression Anxiety Stress Scale (DASS-42) total score
Time frame: Experimental and control group patients will answer questionnaires to monitor their psychological status and physiological symptoms 3 times in total: baseline (month 0), during the treatment (month 3) and at the end of treatment (month 5-6).
The Depression Anxiety Stress Scale (DASS-42) is a self-reported questionnaire designed to measure negative emotional states across three subscales: depression, anxiety, and stress. The total score is calculated by summing all 42 items. Minimum value: 0 Maximum value: 126 (42 items × 0-3 Likert scale) Score interpretation: Higher scores indicate worse psychological distress.
Change from baseline in Edmonton Symptom Assessment System-revised (ESAS-r) total symptom score
Time frame: Baseline (Month 0), during treatment (Month 3), and end of treatment (Month 5-6)
The Edmonton Symptom Assessment System-revised (ESAS-r) is a patient-reported outcome measure assessing the severity of common cancer-related symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and an optional additional symptom. Each symptom is rated on a numeric scale. Minimum value: 0 Maximum value: 100 (10 symptoms × 0-10 numeric rating scale) Score interpretation: Higher scores indicate worse symptom burden.
Change from baseline in frequency of immune cell subsets in peripheral blood and tumor tissue
Time frame: Peripheral blood: Baseline (Month 0) and end of treatment (Month 5-6) Tumor tissue: End of treatment (Month 5-6)
The frequency of immune cell subsets involved in breast cancer immunity will be assessed by flow cytometry. The analyzed cell populations include CD4⁺ T cells, CD8⁺ T cells, regulatory T cells (Treg), NK cells, monocytes in peripheral blood and tumor tissue, and myeloid-derived suppressor cells, as well as M1 and M2 macrophages in tumor tissue only. Cell frequencies will be reported as a percentage of CD45⁺ live cells. Unit of Measure: Percentage (%)
Change from baseline in activation marker expression on immune cell subsets
Time frame: Peripheral blood: Baseline (Month 0) and end of treatment (Month 5-6) Tumor tissue: End of treatment (Month 5-6)
Activation status of immune cells will be evaluated by flow cytometry based on the expression of activation markers. NK cells and T cell subsets will be assessed using CD25, CD69, and HLADR expression, while monocytes and macrophages will be assessed using CD86 and HLADR expression. Activation will be reported as median fluorescence intensity (MFI). Unit of Measure: Median fluorescence intensity (MFI)
Change from baseline in tumor size measured by ultrasound and mammography for the assessment of the effects on disease progression
Time frame: Baseline (Month 0), mid-treatment (Month 3), and end of treatment (Month 5-6)
Tumor size will be assessed using standard clinical imaging methods, including ultrasound and mammography, to evaluate disease progression in patients receiving the UMAY video-immunotherapy or placebo control intervention. Tumor size will be recorded as the largest tumor diameter (in millimeters), according to routine clinical assessment. Unit of Measure: Millimeters (mm)
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 Jan 2026.
- Individual participant dataSharing planned: Yes. We plan to share de-identified IPD through controlled access after publication. Shared variables will include DASS and ESAS scores at baseline, mid-treatment and end-of-treatment; tumor size by ultrasound/mammography at the same time points; and flow-cytometry profiles of CD4+, CD8+, Treg, NK cells, monocytic cells from blood (baseline and month 5-6) and tumor tissue (month 5-6). All data will be anonymized and no direct identifiers will be released. Access will require ethics approval and a data-use agreement. Access will be prioritized for investigators conducting non-commercial research aimed at advancing breast-cancer immunotherapy or improving statistical/clinical reproducibility.
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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.
Duygu Sag, Ph.D. principal investigator
Izmir Biomedicine and Genome Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UMAY - Video-immunotherapy game in people with Female Breast Cancer Patients, run by Izmir Biomedicine and Genome Center at 3 sites in Turkey (Türkiye).
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: enrolling by invitation, as of the sponsor's last update on 23 Jan 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
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?
Change from baseline in Depression Anxiety Stress Scale (DASS-42) total score (time frame: Experimental and control group patients will answer questionnaires to monitor their psychological status and physiological symptoms 3 times in total: baseline (month 0), during the treatment (month 3) and at the end of treatment (month 5-6).). 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 23 Jan 2026.