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ENROLLING BY INVITATION
NCT07357207
NA

Video-immunotherapy: a New Approach in Breast Cancer Treatment

Sponsor: Izmir Biomedicine and Genome Center

View on ClinicalTrials.gov

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 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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-12-01

Completion Date

2027-02-02

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Control - Plasebo Game

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.

Locations (3)

Dokuz Eylul University Hospital

Izmir, Balcova, Turkey (Türkiye)

Akdeniz University Hospital

Antalya, Konyaaltı, Turkey (Türkiye)

Antalya Training and Research Hospital

Antalya, Muratpasa, Turkey (Türkiye)