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Clinical Study of TCM Aromatherapy to Improve Tumor-Related Depression in Breast Cancer Patients During Chemotherapy

Phase 1
Completed
Conditions
Breast Cancer
Registration Number
ChiCTR2400088693
Lead Sponsor
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

(1) Female, aged = 18 years old and = 70 years old;<br>(2) Meet the diagnostic criteria for breast cancer;<br>(3) Meet the diagnostic criteria for tumor-related depression;<br>(4) Mild and moderate depression<br>(5) Currently in the adjuvant chemotherapy stage, and it is expected that there will be no chemotherapy regimen change during the development of this study;<br>(6) Understand, agree to participate in this study and sign the informed consent form.

Exclusion Criteria

(1) Moderate-to-severe depression (PHQ-9=15 points);<br>(2) Patients with severe circulatory, respiratory, digestive, blood, urinary, nervous, and endocrine system diseases, such as acute myocardial infarction, heart failure, renal insufficiency, acute cerebral infarction, lupus erythematosus, etc., and the investigator believes that other systemic diseases of the patient will affect the results of this study;<br>(3) Patients with other severe psychiatric symptoms other than depression or previous mental disorders and positive family history;<br>(4) Those who have participated in other clinical studies or similar types of researchers in the past month;<br>(5) Patients who are allergic to essential oils involved in this study;<br>(6) People with a history of allergic rhinitis and allergic asthma, and impaired sense of smell;<br>(7) Those who have taken anti-anxiety and depression and sleep-improving drugs in the past two weeks;<br>(8) Women who have a plan to get pregnant and are pregnant.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total effective rate in HAMD-24 ;HAMD-24 total score;
Secondary Outcome Measures
NameTimeMethod
TCM syndrome scoring points;Pittsburgh sleep quality index;Incidence of nausea and vomiting;Functional magnetic resonance;
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