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
- 4
- 主要终点
- Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 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
- 未提供
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 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 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 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