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Association of Receptive Music Therapy With Plasma Levels of Epidermal Growth Factor, Interleukin-8 and Neurofilament Light Chain in Women With Breast Cancer
The goal of this clinical study is to investigate whether receptive music therapy can help women with breast cancer by reducing anxiety and depression symptoms, improving quality of life, and influencing specific analytes in plasma, including epidermal growth factor (EGF), interleukin-8 (IL-8), and neurofilament light chain (NfL). Main Questions the Study Aims to Answer: GENERAL OBJECTIVE: To investigate the effect of receptive music therapy on anxiety and depression symptoms, quality of life, and the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma during treatment in women with breast cancer. SPECIFIC OBJECTIVES: * To determine whether there is a correlation between the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma and the severity of anxiety and depression symptoms. * To determine whether there is a correlation between the severity of anxiety and depression symptoms and quality of life. Participants will be randomly assigned to either a music group or a control group. The study will take place during the perioperative period and chemotherapy (in participants for whom chemotherapy will be indicated). At two (perioperative) or three (+ chemotherapy) time points, participants will: * Undergo assessments for anxiety, depression, and quality of life * Provide blood samples for analytes analysis (EGF, IL-8, NfL) * Receive music therapy sessions (for those in the intervention group) The scientific contribution of this study lies in understanding the relationship between the application of receptive music therapy and the plasma levels of epidermal growth factor, interleukin-8, and neurofilament light chain in women with breast cancer during the perioperative period and chemotherapy, as well as its association with the occurrence of pronounced anxiety and depression symptoms related to the malignant process. This study represents the first application of such research in this patient population and serves as a foundation for the future implementation of receptive music therapy in the complementary treatment of breast cancer.
Details
| Lead sponsor | Brigita Vilc |
|---|---|
| Phase | NA |
| Status | ENROLLING_BY_INVITATION |
| Enrolment | 90 |
| Start date | 2024-10-01 |
| Completion | 2026-06 |
Conditions
- Breast Cancer Invasive
- Chemotherapy
- Breast Cancer Surgery
- Breast Cancer
- Positive Axillary Lymph Node
Interventions
- Music intervention
Primary outcomes
- Plasma levels of Epidermal Growth Factor (EGF) — Change from Baseline (Day 1 of hospitalization) to Day 3 of hospitalization, after Week 3 of chemotherapy (where applicable - in participants for whom chemotherapy will be indicated; this time point is approximately 2-3 months post-surgery).
The primary outcome measure assesses changes in plasma levels of Epidermal Growth Factor (EGF) at three time points: baseline (prior to intervention), on 3rd day of hospitalization, and three weeks after chemotherapy initiation (for women for whom the chemotherapy was indicated after the surgery and histopathological report). Plasma analytes concentrations will be measured using the ELISA method and reported in pg/mL. Differences in the levels of these analytes may indicate biological responses to the intervention. - Plasma Levels of Interleukin-8 (IL-8) — Change from Baseline (Day 1 of hospitalization) to Day 3 of hospitalization, after Week 3 of chemotherapy (where applicable - in participants for whom chemotherapy will be indicated; this time point is approximately 2-3 months post-surgery).
The primary outcome measure assesses changes in plasma levels of Interleukin-8 (IL-8) at three time points: baseline (prior to intervention), on 3rd day of hospitalization, and three weeks after chemotherapy initiation (for women for whom the chemotherapy was indicated after the surgery and histopathological report). Plasma analytes concentrations will be measured using the ELISA method and reported in pg/mL. Differences in the levels of these analytes may indicate biological responses to the intervention. - Plasma Levels of Neurofilament Light Chain (NfL) — Change from Baseline (Day 1 of hospitalization) to Day 3 of hospitalization, after Week 3 of chemotherapy (where applicable - in participants for whom chemotherapy will be indicated; this time point is approximately 2-3 months post-surgery).
The primary outcome measure assesses changes in plasma levels of neurofilament light chain (NfL) at three time points: baseline (prior to intervention), on 3rd day of hospitalization, and three weeks after chemotherapy initiation (for women for whom the chemotherapy was indicated after the surgery and histopathological report). Plasma analytes concentrations will be measured using the ELISA method and reported in pg/mL. Differences in the levels of these analytes may indicate biological responses to the intervention.
Countries
Croatia