Acupuncture With or Without Self-acupressure for Hot Flashes in Post-oophorectomy Patients With BRCA Mutations: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Hot Flash Score - baseline to 8 weeks
研究概览
简要总结
Risk-reducing surgery with salpingo-oophorectomy (RRSO) is the standard recommended treatment for all female carriers of BRCA genes 1 and 2. The post-surgical menopause induced is invariably accompanied by hot flashes and other symptoms, which can severely impair quality of life and function. Hormone-replacement therapy (HRT) is the standard conventional treatment for these symptoms, though these drugs do not always provide adequate relief and many patients either cannot receive them due to a diagnosis of breast cancer or hypercoagulable state; or are unwilling to take them due to their concern about the associated increased risk for developing hormone-induced breast cancer.
Acupuncture and acupressure have been researched extensively and shown to be both safe and effective in reducing hot flashes in post-menopausal patients and in those with breast cancer receiving anti-hormonal drugs.
The present study will examine the effectiveness of acupuncture, with/without self-acupressure, on 200 post- RRSO patients who suffer from at least 5 hot flashes per day, including those treated with HRT. All participants will receive 8 weekly treatments with acupuncture, and then randomly assigned to receive (or not) self-administered acupressure, to be performed daily at home. The response to the study interventions will be assessed using daily Hot Flash Scores, the Menopause Specific Quality of Life (MenQoL) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaires (at baseline; at the end of the 8-week intervention; and at 16 weeks). The safety of the study treatments will be assessed throughout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female carriers of the BRCA 1 and 2 genes
- •age ≥ 25 years
- •after risk-reducing salpingo-oophorectomy
- •reporting ≥ 5 hot flashes per day
排除标准
- •Patients not fulfilling the study inclusion criteria will be excluded from participation
研究组 & 干预措施
Acupuncture only
Acupuncture treatments will take place at a frequency of once per week, with each session lasting between 30 to 45 minutes. At each session patients will be re-assessed by the study acupuncturist, with acupuncture points individualized in accordance with the principles of traditional Chinese medicine. At the same time, acupuncturists will include a set group of acupuncture points which have been used in the research of hot flashes: HT-6, Kid-3, Liv-3, SP-6.
干预措施: Acupuncture (Other)
Acupuncture only
Acupuncture treatments will take place at a frequency of once per week, with each session lasting between 30 to 45 minutes. At each session patients will be re-assessed by the study acupuncturist, with acupuncture points individualized in accordance with the principles of traditional Chinese medicine. At the same time, acupuncturists will include a set group of acupuncture points which have been used in the research of hot flashes: HT-6, Kid-3, Liv-3, SP-6.
干预措施: Acupuncture-Acupressure (Other)
Acupuncture-Acupressure
Patients randomly allocated to the acupuncture-acupressure arm of the study will first be treated by the study acupuncturist in accordance with the protocol described in the Acupuncture arm of the study. At the end of the first session, patients in this group will be taught by the study acupuncturist to self-treat at home with acupressure, on the acupressure points PC-7, ST-36, SP-9. Self-acupressure sessions will last between 3-5 minutes each, and will take place 3-4 times each day. At subsequent acupuncture treatments patients will receive reinforcement and guidance to ensure the fidelity of the self-acupuncture treatments
干预措施: Acupuncture (Other)
Acupuncture-Acupressure
Patients randomly allocated to the acupuncture-acupressure arm of the study will first be treated by the study acupuncturist in accordance with the protocol described in the Acupuncture arm of the study. At the end of the first session, patients in this group will be taught by the study acupuncturist to self-treat at home with acupressure, on the acupressure points PC-7, ST-36, SP-9. Self-acupressure sessions will last between 3-5 minutes each, and will take place 3-4 times each day. At subsequent acupuncture treatments patients will receive reinforcement and guidance to ensure the fidelity of the self-acupuncture treatments
干预措施: Acupuncture-Acupressure (Other)
结局指标
主要结局
Hot Flash Score - baseline to 8 weeks
时间窗: From baseline (at study recruitment) to end of intervention (8 weeks)
Hot Flash Score will be calculated by the following equation: Mean number daily hot flashes X mean severity of symptoms (Hot flash severity: 1 - mild; 2 - moderate; 3 - severe)
次要结局
- Hot Flash Score - 8 to 16 weeks(From end of study intervention (at 8 weeks) to end of post-intervention period (16 weeks))
- Measure Yourself Concerns and Wellbeing (MYCAW)(Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks))
- Menopause Specific Quality of Life Questionnaire (MenQOL)(Baseline; End of intervention (8 weeks); Post-treatment follow-up (16 weeks))
研究者
Noah Samuels
Director, Center for Integrative Complementary Medicine
Shaare Zedek Medical Center