Receptive Music Therapy Effects on Anxiety, Depression, QoL, and EGF, IL-8, and NfL During the Breast Cancer Treatment.

NCT07483034 | Enrolling By Invitation DMC

• 1 other identifier: 90Z19012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Invasive; Chemotherapy; Breast Cancer Surgery; Breast Cancer; Positive Axillary Lymph Node

Keywords

music therapy; breast cancer; perioperative period; chemotherapy; anxiety; depression; EGF; IL-8; NfL; quality of life

Outcome Measures

Primary Outcomes (3)

• Plasma levels of Epidermal Growth Factor (EGF)

  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.

  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).

• Plasma Levels of Interleukin-8 (IL-8)

  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.

  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).

• Plasma Levels of Neurofilament Light Chain (NfL)

  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.

  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).

Secondary Outcomes (4)

• Anxiety and Depression Symptoms (HADS)

  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).

• Depression Symptoms (BDI-II)

  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).

• Quality of Life Score (EORTC QLQ-C30 and EORTC QLQ-BR23)

  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).

• Adaptive Functions of Music Listening Scale (AFML) Scores

  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).

Study Arms (2)

Intervention Group (Music Intervention)

EXPERIMENTAL

Other: Music intervention

Control Group (Standard Medical Care)

NO INTERVENTION

In the control group of participants, regular medical procedures will be performed.

Interventions

Music intervention OTHER

The protocol for the application of receptive music therapy in the intervention group will involve listening to music using a music playback device and headphones. Receptive music therapy will be applied twice daily for 30 minutes during the 3-day hospitalization period (in the morning and evening), and for 1 hour during the first three weeks of chemotherapy. The selection of music will be made by the researcher. Classical instrumental music pieces will be chosen based on musical components such as melody, harmony, tempo, rhythm, timbre, intensity, choice of instrument(s), and orchestration. Considering the study's hypothesis and objectives, which focus on inducing changes in symptoms of anxiety and depression under the influence of music therapy and consequently achieving relaxation in affected women, the music used will have a slow to moderate tempo (60-80 beats per minute), with continuous rhythmic patterns without significant tempo fluctuations and gentle melodic line development.

Also known as: Receptive Music Therapy, Music Therapy

Intervention Group (Music Intervention)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female participants only, as the study focuses on breast cancer patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigita Vilc: lead

Study Sites (1)

University Hospital for Tumors, Sestre Milosrdnice University Hospital Center Zagreb, Croatia

Zagreb, City of Zagreb, 10000, Croatia

Location

Related Publications (3)

• Galvez-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 BACKGROUND

• Ma 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 BACKGROUND

• Nightingale 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marina Šagud, PhD, MD

  Clinical Hospital Centre Zagreb

  STUDY CHAIR

• Goran Šimić, PhD, MD

  Croatian Institute for Brain Research, University of Zagreb School of Medicine

  STUDY CHAIR

• Ivan Milas, PhD, MD

  University Hospital for Tumors, Sestre milosrdnice University Hospital Center Zagreb, Croatia

  STUDY DIRECTOR

• Brigita Vilč, Master's Degree, PhD Candidate

  University of Zagreb, Faculty of Education and Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research and Teaching Assistant, Master's Degree at Faculty of Education and Rehabilitation Sciences, University of Zagreb; Master's Degree at Academy of Music, University of Zagreb; PhD Student at Neuroscience, School of Medicine, University of Zagreb

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: March 19, 2026
• Study Start: October 1, 2024
• Primary Completion: September 15, 2025
• Study Completion: June 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)