NCT01005108已完成2 期
Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)
研究概览
简要总结
Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. The investigators primary specific aim will focus on determining the magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Women 18 years or older with a history of Stage I, II or III breast cancer for at least 12 months.
- •Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history;
- •Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary.
- •Hot flashes have been present for at least a month before study entry.
- •Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal.
排除标准
- •Having metastatic breast cancer ( IV)
- •Currently on chemotherapy or radiation therapy as adjuvant treatment
- •Started hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks.
- •Started or changed with treatments for hot flashes, such as SSRIs or clonidine within the last 4 weeks; or plan to change or terminate these therapies in the next 14 weeks.
- •Current use of estrogen and/or progestin.
- •Breast feeding
- •Bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles.
- •Previous use of gabapentin for hot flashes.
- •Current use of any anti-convulsant.
- •Renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal
- •Known allergy to gabapentin.
研究组 & 干预措施
placebo pill
Experimental
干预措施: Gabapentin (Drug)
placebo accupuncture
Experimental
干预措施: Gabapentin (Drug)
accupuncture
Experimental
干预措施: Gabapentin (Drug)
gabapentin
Experimental
干预措施: Gabapentin (Drug)
结局指标
主要结局
Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)
时间窗: Daily starting from baseline until week 12 and again for one week at week 24.
次要结局
- Brief Fatigue Inventory (BFI) - Secondary Outcome(3 minutes)
- Creditability Rating of Acupuncture - Secondary Aim(1 minute)
- Demographics -Covariates(5 minutes)
- Medication and CAM Usage -Covariates(5 minutes)
- Acupuncture Expectancy Scale (AES) - Secondary Aim(1 minute)
- Actigraph Movement Measuring Device(24 hrs/day for 3 days)
- Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome(3 minutes)
- Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome(6 minutes)
- Global Assessment Scale -Secondary Outcome(30 seconds)
- HADS - Secondary Outcome(2 minutes)
研究者
研究点 (1)
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