Hot flashes associated with endocrine therapy for breast cancer
Conditions
Interventions
Control Group:Zhibai Dihuang Tang (Anemarrhena, Phellodendron, and Rehmannia Decoction)
Intervention Group:Daolong Ruhai Tang (Guiding the Dragon to the Sea Decoction)
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Female patients aged 18 years or older; 2) Diagnosed with early-stage (Stage I-IIIa) breast cancer confirmed by histopathology, having completed standard adjuvant chemotherapy/radiotherapy postoperatively, and currently with stable disease; 3) Hormone receptor-positive, currently receiving endocrine therapy with a stable medication regimen for at least 3 months. 4) Experiencing hot flash symptoms for more than 2 weeks; 5) Meeting the Traditional Chinese Medicine syndrome diagnostic criteria for "Liver-Kidney Yin Deficiency with Flaring of Deficient Fire"; 6) Karnofsky Performance Status (KPS) score = 60, with an estimated life expectancy exceeding 1 year; 7) Voluntarily participating in the clinical study and providing signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Known allergy to any component of Daolongruhai Decoction or Zhibai Dihuang Decoction; (2) Use of other medications or therapies for hot flashes within the past 4 weeks; (3) Presence of uncontrolled severe cardiac, hepatic, or renal dysfunction; (4) Presence of any psychiatric or neurological disorders that may interfere with efficacy evaluation; (5) Current participation in other interventional clinical studies; (6) Pregnancy, lactation, or planning to become pregnant within the next 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, severity, and scores of hot flashes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Traditional Chinese Medicine (TCM) Syndrome/Pattern;Insomnia condition;Anxiety Disorder;Fatigue Status; | — |
Countries
China
Contacts
Public ContactXiufei Gao
Zhejiang University of Traditional Chinese Medicine Affiliated First Hospital (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed