Clinical trial · Interventional
Oxidative Stress, Anxiety and Depression in Breast Cancer Patients: Impact of Music Therapy
Analisi Dei Marcatori di Stress Ossidativo in Pazienti Affetti da Tumore Della Mammella, Sottoposte a Radioterapia Postoperatoria e Psicoterapia Con Elementi di Musicoterapia
- 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)
Oxidative stress plays an important role in the development of breast cancer, and also of depression which can affect the ability to deal with cancer. The main objective of this study is to evaluate the impact of a group psychotherapy with elements of music therapy in a population of patients suffering from breast cancer, treated with surgery and undergoing post-operative RT. Study outcomes will be the following: 1. Effectiveness of the proposed intervention especially on anxiety and depression, as described by changes in psychometric test scores. 2. Changes of oxidative stress and inflammation markers, such as high sensitivity C-reactive protein (hs-PCR), fibrinogen and lipoprotein-associated phospholipase A2 (Lp-LPLA2), GSH, TBARS, IL4, IL6, TNF-α, α and γ tocopherol, carotenoids, folic acid, vitamin B12. 3. Correlation between changes of markers (see point 2) and the clinical/psychometric variables under study. Methods This is a prospective randomized monocentric study, which will involve patients diagnosed with early stage invasive breast cancer (pTis-1-2 N0-1 M0), who underwent conservative surgery, and candidates for adjuvant RT. Patients will be identified during the RT visit. Patients who meet the eligibility criteria and who have signed informed consent will be randomized (1:1) as follows: group supportive psychotherapy with elements of music therapy (PSY); control group - treatment as usual (TAU ). Patients will undergo psychometric assessment and blood sampling (10 ml) at T0 (baseline), T1 (last day of RT), T2 (3 months after the end of RT). Study duration will be one year; during the first 9 months, patients will be recruited and treated, in the following period follow-up evaluations will be completed and data analyses will be conducted. Sample size Based on literature data, indicating average anxiety ranges measured with a STAI score from 43.4 to 46.2 and assuming, in the experimental group, a clinically significant reduction of 9 points (Bulfone 2009, Rossetti 2017), 24 patients per group have to be enrolled (alpha: 0.05; Beta: 0.20). Statistical analysis A simple randomization in 1:1 ratio will be carried out. Differences between the 2 groups will be used to assess the impact of psychotherapy intervention with elements of music therapy. A descriptive statistical analysis and estimate of relative risks will be performed.
Conditions
Conditions (3)
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 |
| Depression, Anxiety | — | UNRESOLVED | — |
| Oxidative Stress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Music therapy intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Treatment as usual (TAU)
- description
- Patients in the TAU group will receive the treatment routinely offered to patients undergoing RT for breast cancer.
- type
- EXPERIMENTAL
- label
- Music therapy intervention (PSY)
- description
- Patients in the PSY group will participate to a short-term group psychotherapy with elements of music therapy; meetings will be 1 / week, for a total of 6 weeks. Beginning of psychotherapy intervention will be 1-2 weeks after recruitment at T0 and will therefore cover the entire duration of the RT cycle.
- interventionNames
- Other: Music therapy intervention
Primary outcomes (4)
- measure
- Change in anxiety from baseline to follow-up
- timeFrame
- Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG 0-1 * Age \> 18 years * Histologically confirmed invasive / intraductal breast cancer * Conservative breast surgery (quadrantectomy, nodulectomy) * Free surgical margins * Pathological stage pTis, pT1-2 pN0-1 M0 (according to the TNM classification) * Indication for adjuvant RT * Signature of informed consent Exclusion Criteria: * Age \< 18 years * indication to chemotherapy / targeted therapy * diagnosis of previous major depressive episode * current comorbidity with abuse of alcohol and / or psychotropic substances * ongoing psychopharmacological treatment with antidepressants and / or mood stabilizers * diagnosis of mental retardation, dementia, or other cognitive impairment * autoimmune / inflammatory diseases / diabetes mellitus * pregnancy
References
Publications (35)
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- BACKGROUNDBidstrup PE, Christensen J, Mertz BG, Rottmann N, Dalton SO, Johansen C. Trajectories of distress, anxiety, and depression among women with breast cancer: Looking beyond the mean. Acta Oncol. 2015 May;54(5):789-96. doi: 10.3109/0284186X.2014.1002571. Epub 2015 Mar 11. PMID 25761086
- BACKGROUNDBower JE. Behavioral symptoms in patients with breast cancer and survivors. J Clin Oncol. 2008 Feb 10;26(5):768-77. doi: 10.1200/JCO.2007.14.3248. PMID 18258985
- BACKGROUNDBrunault P, Suzanne I, Trzepidur-Edom M, Garaud P, Calais G, Toledano A, Camus V. Depression is associated with some patient-perceived cosmetic changes, but not with radiotherapy-induced late toxicity, in long-term breast cancer survivors. Psychooncology. 2013 Mar;22(3):590-7. doi: 10.1002/pon.3038. Epub 2012 Feb 7. PMID 22315168
- BACKGROUNDBulfone T, Quattrin R, Zanotti R, Regattin L, Brusaferro S. Effectiveness of music therapy for anxiety reduction in women with breast cancer in chemotherapy treatment. Holist Nurs Pract. 2009 Jul-Aug;23(4):238-42. doi: 10.1097/HNP.0b013e3181aeceee. PMID 19574761
- BACKGROUNDCarr CE, O'Kelly J, Sandford S, Priebe S. Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial. Trials. 2017 Mar 29;18(1):149. doi: 10.1186/s13063-017-1893-8. PMID 28356125
- BACKGROUNDChen SC, Chou CC, Chang HJ, Lin MF. Comparison of group vs self-directed music interventions to reduce chemotherapy-related distress and cognitive appraisal: an exploratory study. Support Care Cancer. 2018 Feb;26(2):461-469. doi: 10.1007/s00520-017-3850-1. Epub 2017 Aug 10.