Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
研究概览
简要总结
This research study is evaluating acupuncture, a medical therapy in which hair-thin, stainless steel needles are shallowly inserted into specific points to help the body's natural healing process, as a possible treatment to reduce hot flashes.
详细描述
Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot flashes are common side effects of breast cancer treatments and can affect mood and daily life. Medications can help ease hot flashes, but many patients continue to experience symptoms despite these treatments.
Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on the skin, with the goal of affecting body's natural healing system. Acupuncture has been tested in clinical trials in cancer patients and has been shown to be helpful in treating a number of side effects of cancer treatment, such as nausea and vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to lessen hot flashes, but more information is needed about the benefits of acupuncture in breast cancer patients.
This study is being done to test whether acupuncture can help to reduce the number and intensity of hot flashes in breast cancer patients who are being treated with mediations such as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
- •Premenopausal or postmenopausal status;
- •Completed all primary chemotherapy and surgery;
- •Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed;
- •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;
- •Age ≥ 18 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Signed informed consent
排除标准
- •Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period;
- •Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
- •Uncontrolled seizure disorder or history of seizure;
- •Active clinically significant uncontrolled infection;
- •Use of acupuncture for hot flashes within 6 months prior to the study entry;
- •Uncontrolled major psychiatric disorders, such as major depression or psychosis;
- •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. Participants may continue with medications or therapies for the treatment of hot-flashes while participating in the study if the medication has been taking for more than 4 weeks prior to study entry AND the dose of the medication is going to be kept consistently during the study
研究组 & 干预措施
Immediate Acupuncture
- Will receive a standardized acupuncture protocol for a 10-week period
- 20 sessions: twice a week for 10 weeks
- After the completion of the 10 weeks main study period, participants will cross over to the usual care as a follow-up without acupuncture for additional 10 weeks.
干预措施: Acupuncture (Device)
Delayed acupuncture
- Will receive standard usual care without acupuncture for 10 weeks
- Participants will cross over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
干预措施: Usual Care (Other)
结局指标
主要结局
Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
时间窗: 10 weeks
Daily Hot Flash Diary (DHFD) The DHFD is a measure of self-reported hot flash data that uses a diary to record the frequency and severity of hot flashes based on a 4-point scale (i.e., mild, moderate, severe, or very severe) to provide a hot flash score/index that reflects both number and severity of hot flashes (i.e., sum of the number of hot flashes multiplied by a weighted severity). Patients were asked to record daily for a week at five time points through the trial: baseline, week 5, week 10, week 15, and week 20. Negative changes would suggest improvements in number, type, or severity.
次要结局
- Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer(10 weeks)
- Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)(10 weeks)
研究者
Weidong Lu, MB, MPH, PhD
Principal Investigator
Dana-Farber Cancer Institute