Psychosomatic symptoms associated with breast cancer chemotherapy
Conditions
Interventions
control group:Basic treatment plan: standardized chemotherapy plan (based on the 2023 Chinese Society of Clinical Oncology Breast Cancer Diagnosis and Treatment Guidelines) +Prophylactic antiemetic re
intervention group:Basic Treatment Plan + Fuxia Dihuang Tang
Sponsors
Xiamen Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Female, aged 18-75 years (both 18 and 75 years); (2) Stage I-IIIA breast cancer patients with a clear pathologic diagnosis who received surgical treatment and postoperative chemotherapy; (3) KPS =60 and expected survival =1 year; (4) Patients who receive chemotherapy for the first time and enter the maintenance phase with more than stable disease as evaluated by efficacy after 2-4 cycles of chemotherapy; (5) Patients with anxiety states, 14 points = Hamilton Anxiety Scale (HAMA) < 29 points; (6) or with symptoms of insomnia and a Pittsburgh Sleep Quality Index (PSQI) score of =7; (7) Patients consistent with the liver and kidney yin deficiency type; (8) Have some ability to understand and express themselves, participate in this study voluntarily, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients on dose-dense chemotherapy regimens; (2) Individuals with a history of uncontrollable psychosis and patients with moderate to severe cognitive impairment; (3) Severe anxiety requiring treatment with oral anxiolytic western medication and a Hamilton Anxiety Scale (HAMA) score of =29; (4) Received psychotherapy or psychological intervention within the last month; (5) Taking sleeping and anti-anxiety medications within two weeks prior to the study; (6) Allergic, or those who have experienced allergic reactions to Chinese medicines or have proven allergy to the ingredients of Fuxia Dihuang Tang; (7) Patients who are receiving other antitumor therapeutic measures in addition to those specified in this protocol or who are participating in other clinical trials; (8) Expected progression of invasive breast cancer disease deterioration during the study period requiring treatment with radiotherapy; (9) Combination of other malignant tumors or the presence of severe cardiac, hepatic, or renal dysfunction (laboratory indicators exceeding two times the upper limit of normal values); (10) Those with serious comorbidities, active infections, severe bleeding tendencies, and hematopoietic abnormalities; (11) A history of active viral hepatitis B, active viral hepatitis C, human immunodeficiency virus (HIV) infection, or other acquired, congenital immunodeficiency diseases; (12) Pregnant and lactating women of childbearing age who are unwilling to use effective contraception throughout the experimental period; (13) Suspected or confirmed history of alcohol and drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety Clinical Effectiveness; | — |
Secondary
| Measure | Time frame |
|---|---|
| State Trait Anxiety Inventory Scores;Traditional Chinese medicine syndrome Score;Pittsburgh Sleep Quality Index Scale Scores;Insomnia Clinical Effectiveness;Epworth Sleepiness Scale Score ;Quality of Life Scale;Completion of chemotherapy; | — |
Countries
China
Contacts
Public ContactXiao-hua Pei
Xiamen Hospital of Traditional Chinese Medicine
Outcome results
None listed