Acupuncture for Hot Flashes in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment
研究概览
简要总结
RATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer.
PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes in patients with prostate cancer who are undergoing androgen deprivation.
详细描述
OBJECTIVES:
- Determine the impact of acupuncture therapy on the frequency and intensity of hot flashes and the quality of life of patients with prostate cancer undergoing androgen deprivation.
- Determine if blood serotonin and urinary 5-HIAA are increased in patients treated with acupuncture.
- Determine if plasma calcitonin gene-related peptide and MHPG are reduced in patients with hot flashes due to androgen deprivation treated with acupuncture.
- Determine the ability of tongue diagnosis, a traditional Chinese clinical assessment method, to predict clinical and biological changes in these patients.
- Determine the effect of acupuncture on insomnia and loss of vitality caused by hot flashes in these patients.
OUTLINE: Patients undergo acupuncture for 30 minutes twice weekly for 4 weeks and then once weekly for an additional 6 weeks.
Quality of life is assessed at baseline, at weeks 2, 4, 6, and 10, and then at 6 weeks after completion of study treatment.
After completion of study treatment, patients are followed at 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of prostate cancer
- •Hot flash score ≥ 4 per day
- •Prior or concurrent treatment with 1 of the following :
- •Bilateral orchiectomy
- •Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy
- •Antiandrogen therapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No mental impairment
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •More than 4 weeks since prior estrogen or progestational drugs
- •See Disease Characteristics
- •No prior placement of a pacemaker or other implantable electrical device
- •More than 4 weeks since prior gabapentin
- •No concurrent antidepressant drugs
排除标准
- 未提供
结局指标
主要结局
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment
时间窗: 10 Weeks after initiation of study treatment.
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment
时间窗: Weeks 4 after initiation of study treatment.
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 16 weeks after initiation of study treatment
时间窗: 16 Weeks after initiation of study treatment.
次要结局
- Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 4 weeks after initiation of study treatment(4 Weeks after initiation of study treatment.)
- Change in biomarkers at baseline after initiation of study treatment(Baseline after initiation of study treatment.)
- Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 10 weeks after initiation of study treatment(10 weeks after initiation of study treatment.)
- Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 16 weeks after initiation of study treatment(16 Weeks after intiation of study treatment.)
- Change in biomarkers at 4 weeks after initiation of study treatment(4 Weeks after initiation of study treatment.)
研究者
Tom Beer
Principal Investigator
OHSU Knight Cancer Institute