Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:22 AM
Study NCT ID:
NCT07483034
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-19
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Receptive Music Therapy Effects on Anxiety, Depression, QoL, and EGF, IL-8, and NfL During the Breast Cancer Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}, {'measure': 'Plasma Levels of Interleukin-8 (IL-8)', '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 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.'}, {'measure': 'Plasma Levels of Neurofilament Light Chain (NfL)', '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 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.'}], 'secondaryOutcomes': [{'measure': 'Anxiety and Depression Symptoms (HADS)', '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 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).\n\nDifferences in these measures may indicate different psychological responses to the intervention.\n\nHADS: 11 items; 0 to 3 scale, total score: 0 to 42. Higher scores indicate greater levels of anxiety and/or depression.'}, {'measure': 'Depression Symptoms (BDI-II)', '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': '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.\n\nBDI-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.'}, {'measure': 'Quality of Life Score (EORTC QLQ-C30 and EORTC QLQ-BR23)', '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 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.\n\nEORTC 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.'}, {'measure': 'Adaptive Functions of Music Listening Scale (AFML) Scores', '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 Adaptive Functions of Music Listening Scale will be administered both in the intervention and control groups at three time points.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music therapy', 'breast cancer', 'perioperative period', 'chemotherapy', 'anxiety', 'depression', 'EGF', 'IL-8', 'NfL', 'quality of life'], 'conditions': ['Breast Cancer Invasive', 'Chemotherapy', 'Breast Cancer Surgery', 'Breast Cancer', 'Positive Axillary Lymph Node']}, 'referencesModule': {'references': [{'pmid': '27618303', 'type': 'BACKGROUND', 'citation': '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': '28791816', 'type': 'BACKGROUND', 'citation': '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': '23625027', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nMain Questions the Study Aims to Answer:\n\nGENERAL OBJECTIVE:\n\nTo 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.\n\nSPECIFIC OBJECTIVES:\n\n* 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.\n* To determine whether there is a correlation between the severity of anxiety and depression symptoms and quality of life.\n\nParticipants will be randomly assigned to either a music group or a control group.\n\nThe study will take place during the perioperative period and chemotherapy (in participants for whom chemotherapy will be indicated).\n\nAt two (perioperative) or three (+ chemotherapy) time points, participants will:\n\n* Undergo assessments for anxiety, depression, and quality of life\n* Provide blood samples for analytes analysis (EGF, IL-8, NfL)\n* Receive music therapy sessions (for those in the intervention group)\n\nThe 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.', 'detailedDescription': '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.\n\nThis 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).\n\nStudy Design:\n\nParticipants 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.\n\nIntervention:\n\nBoth 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.\n\nMusic Therapy Protocol:\n\n* Perioperative period: Two 30-minute sessions per day for three days of hospitalization (morning and evening)\n* Chemotherapy period: One-hour sessions during the first three weeks of chemotherapy administration\n\nThe type of chemotherapy determines the frequency of music therapy: 4 cycles of taxanes (weekly) or 2 cycles of anthracyclines (every three weeks).\n\nThe control group will receive standard medical procedures without music therapy.\n\nMusic Selection:\n\nThe research team will select classical instrumental music based on specific musical parameters conducive to relaxation:\n\n* Slow to moderate tempo (60-80 bpm)\n* Smooth rhythmic patterns without abrupt fluctuations\n* Gentle melodic progression without dissonant interval jumps\n* Consonant harmonic progressions\n* Gradual and predictable dynamic changes\n* Sound intensity between 65-80 dB, based on participant preference\n* Audio quality of at least 320 kbit/s\n\nHeadphones will enhance auditory focus and minimize environmental distractions.\n\nData Collection and Assessment:\n\nParticipants 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:\n\n1. Day 1 of hospitalization (before the first music therapy session in the intervention group)\n2. Day 3 of hospitalization\n3. Three weeks after chemotherapy initiation (after the last music therapy session in the intervention group, in participants for whom chemotherapy will be indicated)\n\nThe following instruments will be used:\n\n1. Hospital Anxiety and Depression Scale (HADS)\n2. Beck Depression Inventory-II (BDI-II)\n3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)\n4. Adaptive Functions of Music Listening Scale (administered during music listening in the intervention group or standard medical procedures in the control group)\n\nBlood samples will be collected at the same three time points to measure:\n\n* Epidermal Growth Factor (EGF)\n* Interleukin-8 (IL-8)\n* Neurofilament Light Chain (NfL)\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female participants only, as the study focuses on breast cancer patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Breast Cancer (Ca mammae, C50),\n* Age: 18-65 years\n* Treatment at the University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia\n* 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)\n* Administration of systemic oncological treatment - adjuvant chemotherapy (anthracycline or taxane-based cytostatics)\n* First occurrence of malignant disease\n* Early invasive breast cancer\n* Absence of metastases\n* Possible positive axillary lymph nodes\n* No history of hearing impairment\n\nExclusion Criteria:\n\n* Presence of primary malignant process in other organs\n* Ductal carcinoma in situ\n* Previous malignant disease\n* Recurrence of Breast Cancer\n* Prior chemotherapy\n* Neoadjuvant chemotherapy\n* Diagnosis of anxiety and depressive disorders in the past three years\n* Other severe psychiatric disorders (bipolar disorder, schizophrenia)\n* Use of psychopharmacotherapy\n* Inability to read and write in Croatian\n* Presence of intellectual disabilities\n* Professional musicians (classical music)\n* Use of a hearing aid'}, 'identificationModule': {'nctId': 'NCT07483034', 'briefTitle': 'Receptive Music Therapy Effects on Anxiety, Depression, QoL, and EGF, IL-8, and NfL During the Breast Cancer Treatment.', 'organization': {'class': 'OTHER', 'fullName': 'University of Zagreb'}, 'officialTitle': 'Association of Receptive Music Therapy With Plasma Levels of Epidermal Growth Factor, Interleukin-8 and Neurofilament Light Chain in Women With Breast Cancer', 'orgStudyIdInfo': {'id': '90Z19012'}}, 'armsInterventionsModule': {'armGroups': [{'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.'}], 'interventions': [{'name': 'Music intervention', 'type': 'OTHER', 'otherNames': ['Receptive Music Therapy', 'Music Therapy'], 'description': "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.\n\nThe 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.", 'armGroupLabels': ['Intervention Group (Music Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'state': 'City of Zagreb', 'country': 'Croatia', 'facility': 'University Hospital for Tumors, Sestre Milosrdnice University Hospital Center Zagreb, Croatia', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'overallOfficials': [{'name': 'Marina Šagud, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Hospital Centre Zagreb'}, {'name': 'Goran Šimić, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Croatian Institute for Brain Research, University of Zagreb School of Medicine'}, {'name': 'Ivan Milas, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital for Tumors, Sestre milosrdnice University Hospital Center Zagreb, Croatia'}, {'name': "Brigita Vilč, Master's Degree, PhD Candidate", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zagreb, Faculty of Education and Rehabilitation Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared to guarantee participant confidentiality and compliance with data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brigita Vilc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "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", 'investigatorFullName': 'Brigita Vilc', 'investigatorAffiliation': 'University of Zagreb'}}}}