Hot flashes in a patient with hormone receptor positive breast cancer
Conditions
Interventions
Sponsors
Jiangsu Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor; 2. Premenopausal or postmenopausal status; 3. Post chemotherapy (if administered) and surgery; 4. Currently undergoing adjuvant hormonal therapy (eg. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at the study entry; 5. Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry; 6. Aged >= 18 years; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently undergoing chemotherapy or radiation or have surgery planned during protocol period; 2. Unstable cardiac disease or myocardial infarction within 6 months prior to study entry; 3. Uncontrolled seizure disorder or history of seizure; 4. Active clinically significant uncontrolled infection; 5. Use of acupuncture for hot flashes within 6 months prior to the study entry; 6. Uncontrolled major psychiatric disorders, such as major depression or psychosis; 7. Newly starting pharmacologic treatment of hot flashes such as selective serotonin reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily of hectic fever;Breast cancer function scale;Endocrine subscale for breast cancer;Pittsburgh Sleep Quality Rating Scale; | — |
Countries
China
Contacts
Public ContactYao Chang
Jiangsu Hospital of Traditional Chinese Medicine
Outcome results
None listed