None listed
Conditions
Interventions
Others : Participants will be randomized to an immediate acupuncture group or to a delayed acupuncture control group. Participants in the immediate acupuncture arm will receive a standardized acupunct
while the participants in the control arm will receive usual care for 10 weeks. After the 10 week intervention or control period, participants in the immediate acupuncture arm will cross over to rece
Sponsors
The Catholic University of Daegu
Eligibility
Sex/Gender
Female
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. Completed 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. Age = 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 |
|---|---|
| Functional Assessment of Cancer therapy-Endocrine Subscale (FACT-ES) | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Assessment of Cancer therapy-Breast cancer (FACT-B);Pittsburgh sleep quality index (PSQI);European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 36 & Breast Cancer-specific module 23 (EORTC QLQ-C30 & EORTC QLQ-BR23);Daily Hot Flash Diary (DHFD) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Ju Jeong
Daegu Catholic University Medical Center
Outcome results
None listed