Oxidative Stress, Anxiety and Depression in Breast Cancer Patients: Impact of Music Therapy

NCT04446624 | Completed

• 1 other identifier: CE 193/17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Effectiveness of the proposed intervention especially on anxiety and depression, as described by changes in psychometric test scores.
2. 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. 3.Correlation between changes of markers (see point 2) and the clinical/psychometric variables under study.

Conditions

Breast Cancer; Depression, Anxiety; Oxidative Stress

Keywords

Oxidative stress; Radiotherapy; Music therapy; Quality of life; Resilience; Breast cancer; Depression and anxiety

Outcome Measures

Primary Outcomes (4)

• Change in anxiety from baseline to follow-up

  Anxiety is assessed with the State-Trait Anxiety Inventory 1 and 2 (STAI Y1, STAI Y2), a 40-item self-administered test for the assessment of state and trait anxiety. Each item is rated 1 to 4 (1= not at all, 4= severe); no specific cut-off scores exist. The highest the score, the greater is anxiety.

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

• Change in depression from baseline to follow-up

  Depression is assessed with the Montgomery-Asberg Depression Rating Scale (MADRS and with the Beck Depression Inventory (BDI). The MADRS is a 10-item clinician-rated scale for depressive symptoms detection and severity assessment. Each item is rated on a six-point scale, hence 60 is the maximum total score indicating the maximum severity of depressive symptoms. A score \<6 points stands for no depression (normal), 7-19 mild depression, 20-34 moderate depression, ≥ 35 severe depression. The BDI is a 21-item self-administered test for the evaluation of subjective depressive feelings or symptoms. It is rated on a 4-points scale (from 0 to 3 according to severity), with the following cutoff values: 0-9 minimal depression, 10-18 mild depression, 19-29 moderate depression, 30-63 severe depression.

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

• Change in Glutathione (GSH) from baseline to follow-up

  GSH measurement was performed through the Glutathione Assay Kit (Cayman Chemical, Ann Arbor, MI, USA). For the experiments, each plasma sample was deproteinated and centrifuged at 2000 g for 2 min. Fifty μl of the samples was transferred to a 96-well plate where GSH was detected through a spectrophotometer (VICTOR™ X Multilabel Plate Reader), at excitation/emission wavelengths of 405-414 nm. To ensure accurate GSH quantification (expressed as µM), a reference curve with the GSH Standard was prepared (range of known GSH concentration: 0-16 μM). As regards the performance of the assay, variation coefficient of 3.6% for inter-assay and 1.6% for intra-assay is reported.

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

• Change in TBARS from baseline to follow-up

  TBARS were determined as malonyldialdeide (MDA) release. MDA measurement was performed by using the TBARS assay Kit (Cayman Chemical). For the experiments, 100 µl of each plasma sample was added to 100 µl of sodium dodecyl sulfate (SDS) solution and 2 ml of the Color Reagent. After centrifugation, 150 μl of each sample was transferred to a 96-well plate where MDA was detected through a spectrophotometer (VICTOR™ X Multilabel Plate Reader), at excitation/emission wavelengths of 530-540 nm. In order to quantify the correct values of TBARS (expressed as µM MDA), a reference standard curve was prepared (range of known TBARS concentration: 0-50 μM). As regards the performance of the assay, intra-coefficient of variation of 5.5% and an inter-coefficient variation of 5.9% is reported.

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

Secondary Outcomes (6)

• Change in resilience from baseline to follow-up

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

• Change in quality of life from baseline to follow-up

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

• Change in Human IL-6 from baseline to follow-up

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

• Change in Human TNFα from baseline to follow-up

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

• Change in Retinol, α and γ -tocopherol, lycopene and β carotene from baseline to follow-up

  Time T0 (pre-RT); Time T1 (through RT completion, an average of 27 days); Time T2 (3 months after the end of RT)

Study Arms (2)

Treatment as usual (TAU)

NO INTERVENTION

Patients in the TAU group will receive the treatment routinely offered to patients undergoing RT for breast cancer.

Music therapy intervention (PSY)

EXPERIMENTAL

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.

Other: Music therapy intervention

Interventions

Music therapy intervention OTHER

Group psychotherapy with music intervention

Music therapy intervention (PSY)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead

Study Sites (1)

Department of Translational Medicine, Università del Piemonte Orientale

Novara, 28100, Italy

Location

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MeSH Terms

Conditions

Breast Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Marco Krengli, MD

  University of Piemonte Orientale

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 25, 2020
• Study Start: February 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)