Clinical trial · Interventional
Receptive Music Therapy Effects on Anxiety, Depression, QoL, and EGF, IL-8, and NfL During the Breast Cancer Treatment.
Association of Receptive Music Therapy With Plasma Levels of Epidermal Growth Factor, Interleukin-8 and Neurofilament Light Chain in Women With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Invasive | — | UNRESOLVED | — |
| Breast Cancer Surgery | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Positive Axillary Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Music intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group (Music Intervention)
- interventionNames
- Other: Music intervention
- type
- NO_INTERVENTION
- label
- Control Group (Standard Medical Care)
- description
- In the control group of participants, regular medical procedures will be performed.
Primary outcomes (3)
- measure
- Plasma levels of Epidermal Growth Factor (EGF)
- timeFrame
- 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).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Breast Cancer (Ca mammae, C50), * Age: 18-65 years * Treatment at the University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia * Hospitalization during perioperative period while undergoing primary surgical removal of malignant neoplasm (segmentectomy or mastectomy with axillary lymph node dissection or sentinel lymph node biopsy; including possible reconstruction in the same surgery after mastectomy) * Administration of systemic oncological treatment - adjuvant chemotherapy (anthracycline or taxane-based cytostatics) * First occurrence of malignant disease * Early invasive breast cancer * Absence of metastases * Possible positive axillary lymph nodes * No history of hearing impairment Exclusion Criteria: * Presence of primary malignant process in other organs * Ductal carcinoma in situ * Previous malignant disease * Recurrence of Breast Cancer * Prior chemotherapy * Neoadjuvant chemotherapy * Diagnosis of anxiety and depressive disorders in the past three years * Other severe psychiatric disorders (bipolar disorder, schizophrenia) * Use of psychopharmacotherapy * Inability to read and write in Croatian * Presence of intellectual disabilities * Professional musicians (classical music) * Use of a hearing aid
References
Publications (3)
- BACKGROUNDGalvez-Contreras AY, Campos-Ordonez T, Lopez-Virgen V, Gomez-Plascencia J, Ramos-Zuniga R, Gonzalez-Perez O. Growth factors as clinical biomarkers of prognosis and diagnosis in psychiatric disorders. Cytokine Growth Factor Rev. 2016 Dec;32:85-96. doi: 10.1016/j.cytogfr.2016.08.004. Epub 2016 Sep 8. PMID 27618303
- BACKGROUNDMa Y, Ren Y, Dai ZJ, Wu CJ, Ji YH, Xu J. IL-6, IL-8 and TNF-alpha levels correlate with disease stage in breast cancer patients. Adv Clin Exp Med. 2017 May-Jun;26(3):421-426. doi: 10.17219/acem/62120. PMID 28791816
- BACKGROUNDNightingale CL, Rodriguez C, Carnaby G. The impact of music interventions on anxiety for adult cancer patients: a meta-analysis and systematic review. Integr Cancer Ther. 2013 Sep;12(5):393-403. doi: 10.1177/1534735413485817. Epub 2013 Apr 26. PMID 23625027