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

March 16, 2026 updated by: Brigita Vilc

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted at the Center for Malignant Diseases at the University Hospital for Tumors, Sestre milosrdnice University Hospital Center in Zagreb, Croatia. The Ethics Committee of the Sestre milosrdnice University Hospital Center has approved the study.

This is a quantitative, randomized clinical trial involving a targeted group of female participants diagnosed with breast cancer (C50), aged 18-65, during the perioperative period of malignant neoplasm removal (segmentectomy or mastectomy with axillary lymph node dissection or sentinel lymph node biopsy; with possible breast reconstruction in the same surgery after mastectomy) and during systemic oncological treatment with adjuvant chemotherapy (anthracyclines or taxanes).

Study Design:

Participants will be randomly assigned to either an intervention or control group to assess the effects of receptive music therapy on anxiety and depression. Baseline stratification according to anxiety and depression levels will be conducted.

Intervention:

Both groups will undergo conventional medical treatments, including surgery and adjuvant chemotherapy. The intervention group will also receive receptive music therapy. Participants in this group will listen to selected classical instrumental music using audio devices and headphones.

Music Therapy Protocol:

  • Perioperative period: Two 30-minute sessions per day for three days of hospitalization (morning and evening)
  • Chemotherapy period: One-hour sessions during the first three weeks of chemotherapy administration

The type of chemotherapy determines the frequency of music therapy: 4 cycles of taxanes (weekly) or 2 cycles of anthracyclines (every three weeks).

The control group will receive standard medical procedures without music therapy.

Music Selection:

The research team will select classical instrumental music based on specific musical parameters conducive to relaxation:

  • Slow to moderate tempo (60-80 bpm)
  • Smooth rhythmic patterns without abrupt fluctuations
  • Gentle melodic progression without dissonant interval jumps
  • Consonant harmonic progressions
  • Gradual and predictable dynamic changes
  • Sound intensity between 65-80 dB, based on participant preference
  • Audio quality of at least 320 kbit/s

Headphones will enhance auditory focus and minimize environmental distractions.

Data Collection and Assessment:

Participants will provide Informed Consent Form and demographic information (age, marital status, education, employment, prior musical training). Clinical data will be collected, and validated psychological instruments will assess anxiety, depression, and quality of life at three time points:

  1. Day 1 of hospitalization (before the first music therapy session in the intervention group)
  2. Day 3 of hospitalization
  3. Three weeks after chemotherapy initiation (after the last music therapy session in the intervention group, in participants for whom chemotherapy will be indicated)

The following instruments will be used:

  1. Hospital Anxiety and Depression Scale (HADS)
  2. Beck Depression Inventory-II (BDI-II)
  3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  4. Adaptive Functions of Music Listening Scale (administered during music listening in the intervention group or standard medical procedures in the control group)

Blood samples will be collected at the same three time points to measure:

  • Epidermal Growth Factor (EGF)
  • Interleukin-8 (IL-8)
  • Neurofilament Light Chain (NfL)

The measurement of analytes (potential biological markers) from blood will be performed using the ELISA method in the Laboratory for Neurodevelopmental Pathology, led by Professor Goran Šimić, PhD, MD, at the Croatian Institute for Brain Research. Statistical analysis will include descriptive statistics and methods for testing differences between groups, as well as normality testing, which will determine the use of parametric or non-parametric statistical tests. Regression analysis will measure the association of EGF, IL-8, and NfL levels concerning the intervention effect.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • University Hospital for Tumors, Sestre Milosrdnice University Hospital Center Zagreb, Croatia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (Music Intervention)
Other: Music intervention

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.

Other Names:
  • Music Therapy
  • Receptive Music Therapy
No Intervention: Control Group (Standard Medical Care)
In the control group of participants, regular medical procedures will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma levels of Epidermal Growth Factor (EGF)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression Symptoms (HADS)
Time Frame: 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 secondary outcome measure assesses changes in symptoms of anxiety and depression at three time points. Symptoms of anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS).

Differences in these measures may indicate different psychological responses to the intervention.

HADS: 11 items; 0 to 3 scale, total score: 0 to 42. Higher scores indicate greater levels of anxiety and/or depression.
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)
Time Frame: 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 secondary outcome measure assesses changes in symptoms depression at three time points. Symptoms of depression will be measured using the Beck Depression Inventory-II (BDI-II). Differences in these measures may indicate different psychological responses to the intervention.

BDI-II: 21 items, each scored on a 0 to 3 scale. The total score: 0 to 63. Higher scores indicating greater severity of depressive symptoms.
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)
Time Frame: 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 secondary outcome measure assesses changes in Quality of Life at three time points. Quality of life will be assessed using EORTC QLQ-C30 (the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) with QLQ-BR23 - an extension of the core questionnaire.

EORTC QLQ-C30: 30 items across Global Health Status, Functional Scales, Symptom Scales, Single-item symptoms; 1-4 scale (global health 1-7). Higher functional scores indicate better functioning, while higher symptom scores indicate greater symptom burden. EORTC QLQ-BR2assessing treatment-related symptoms, body image, sexual functioning, and systemic therapy side effects; 1-4 scale. Higher functional scores indicate better functioning, while higher symptom scores indicate greater symptom burden.
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
Time Frame: 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 Adaptive Functions of Music Listening Scale will be administered both in the intervention and control groups at three time points.

The Adaptive Functions of Music Listening (AFML) scale consists of 48 items assessing 11 factors: stress regulation, anxiety regulation, anger regulation, loneliness regulation, rumination, reminiscence, strong emotional experiences, awe and appreciation, cognitive regulation, identity, and sleep functions. Each item is rated on a 5-point Likert scale (1 to 5), with higher scores indicating greater use of music for specific adaptive functions.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigita Vilc

Investigators

  • Study Chair: 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 Director: Ivan Milas, PhD, MD, University Hospital for Tumors, Sestre Milosrdnice University Hospital Center Zagreb, Croatia
  • Principal Investigator: Brigita Vilč, Master's Degree, PhD Candidate, University of Zagreb, Faculty of Education and Rehabilitation Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

September 15, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90Z19012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared to guarantee participant confidentiality and compliance with data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Music intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe