Video-immunotherapy: a New Approach in Breast Cancer Treatment

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change from baseline in Depression Anxiety Stress Scale (DASS-42) total score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (Month 0), mid-treatment (Month 3), and end of treatment (Month 5-6)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Chronic use of immunosuppressive drugs (e.g. steroids)
• Active immunodeficiency
• Having any disability to play video games

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 3 центра

• Dokuz Eylul University Hospital — Izmir
• Akdeniz University Hospital — Antalya
• Antalya Training and Research Hospital — Antalya

Идентификаторы

NCT: NCT07357207 · iBG-2022-017 · 121C245

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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