Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 16
- 主要终点
- success
研究概览
简要总结
The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Prior PC diagnosis
- •No evidence of Prostate Cancer
- •Clinically meaningful nocturia, defined as ≥2 nocturia episodes every night for the past month
排除标准
- •<1 month since completion of PC treatment (surgery, chemotherapy, radiation, ADT)
- •Score of ≥5 on the STOP-Bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea
- •Other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome)
- •Untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia)
- •Initiation of new medications for urinary symptoms in the past 4 weeks
- •Altered dosing of medications for urinary symptoms in the past 4 weeks
- •Plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study
- •Implanted electronically charged medical device
- •Unable to provide consent for himself
- •Unwilling to adhere to all study-related procedures
结局指标
主要结局
success
时间窗: 1 year
If a participant completes at least 8 out of 10 acupuncture sessions. Feasibility will be evaluated based on the respective definitions of success for the acupuncture.
次要结局
未报告次要终点