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Breast Cancer InvasiveNCT07483034

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

A study testing Music intervention in people with Breast Cancer Invasive and Chemotherapy, run by Brigita Vilc at 1 site in Croatia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Music intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCroatia
Study dates
1 Oct 2024to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Early invasive breast cancer
  • Absence of metastases
  • Possible positive axillary lymph nodes
  • No history of hearing impairment

Who cannot join

  • Presence of primary malignant process in other organs
  • Ductal carcinoma in situ
  • Previous malignant disease
  • Recurrence of Breast Cancer
  • Prior chemotherapy
  • Neoadjuvant chemotherapy
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Croatia1 site

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

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

About this study

Official title: 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:

Read more

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.

Read the 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.

Being tested
Music intervention
Keywords
music therapy, breast cancer, perioperative period, chemotherapy, anxiety, depression, EGF, IL-8, NfL, quality of life
Medical subject headings
Breast Neoplasms, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music interventionOther

    Also called Receptive Music Therapy, Music Therapy

    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.

Study groups in NCT07483034
Study groupRoleWhat they receive
Intervention Group (Music Intervention)ExperimentalNot described
Receives: Other: Music intervention
Control Group (Standard Medical Care)No interventionIn the control group of participants, regular medical procedures will be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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).

  3. 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.

    Measured: 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)

  1. Anxiety and Depression Symptoms (HADS)

    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.

    Measured: 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).

  2. Depression Symptoms (BDI-II)

    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.

    Measured: 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).

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

    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.

    Measured: 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).

  4. Adaptive Functions of Music Listening Scale (AFML) Scores

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start1 Oct 2024
  3. Primary completion15 Sep 2025
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483034
Sponsor's protocol ID
90Z19012
Status last verified
Mar 2026
First submitted
2 Dec 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared to guarantee participant confidentiality and compliance with data protection regulations.

Publications

  • 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.

    PubMed 27618303

  • 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.

    PubMed 28791816

  • 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.

    PubMed 23625027

Questions about this trial

What is this clinical trial studying?

A study testing Music intervention in people with Breast Cancer Invasive and Chemotherapy, run by Brigita Vilc at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07483034, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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