Status:
COMPLETED
Oxidative Stress, Anxiety and Depression in Breast Cancer Patients: Impact of Music Therapy
Lead Sponsor:
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Conditions:
Breast Cancer
Depression, Anxiety
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Detailed Description
Background Mood alterations, particularly depression, are defined by the National Comprehensive Cancer Network (NCCN) as "multi-factorial unpleasant emotional experiences of psychological (cognitive,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04446624
Start Date
February 1 2018
End Date
December 31 2019
Last Update
June 25 2020
Active Locations (1)
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1
Department of Translational Medicine, Università del Piemonte Orientale
Novara, Italy, 28100