Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- SERT uptake ratios
研究概览
简要总结
RATIONALE: New imaging procedures, such as single photon emission computed tomography, may help in learning how acupuncture affects serotonin levels in the brain of breast cancer survivors. PURPOSE: This phase I trial is studying the best way to visualize the effect of acupuncture on brain serotonin in breast cancer survivors.
详细描述
Detailed Description
OBJECTIVES:
I. To determine the feasibility of using [123-I] ADAM Serotonin transporter (SERT) binding as a putative biomarker to visualize the mechanism of effects of acupuncture for hot flashes involving serotonin.
OUTLINE: Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.
After completion of study treatment, patients are followed for 4 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
- Diagnostic
- 盲法
- None
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
- •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
- •Have been receiving endocrine therapy (tamoxifen or aromatase inhibitors for at least four weeks)
- •Experienced hot flashes with a hot flash composite score of 5 or greater per day
- •Hot flashes have been present for at least a month before study entry
排除标准
- •Currently on chemotherapy or radiation therapy as adjuvant treatment
- •Started with 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
- •Any history of use of psychotropic medication such as SSRI use for the past 6 months
- •Any past use of centrally acting medications such as clonidine for the past 6 months
- •Any past diagnosis of a Major Depressive Episode within the last 6 months
- •Any allergy to iodine or shell-fish or radio-nuclear materials
- •Current use of estrogen and/or progestin
- •Pregnancy
- •Breast feeding
- •Women of child-bearing potential NOT willing to use a medically acceptable form of contraception
- •Current use of any anti-convulsant such as gabapentin
- •History of cerebral infarction (including lacunar infarct with symptoms >= 24 hours duration)
- •History of Binswanger's disease (or a history of hypertensive encephalopathy)
- •History of intracranial hemorrhage
- •History of head trauma with loss of consciousness
- •History of encephalitis
- •History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide)
- •Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus)
- •History of normal pressure hydrocephalus
- •History of Parkinson's or other basal ganglia disease
- •History of substance abuse in the previous 6 months
研究组 & 干预措施
I
Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.
干预措施: Single Photon Emission Computed Tomography (Procedure)
I
Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.
干预措施: Acupuncture Therapy (Procedure)
I
Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.
干预措施: Questionnaire Administration (Other)
I
Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
SERT uptake ratios
Hot flash composite score (HFCS)
次要结局
- Hot flash related daily interference scale (HFRDIS)
- Pittsburgh sleep quality index (PSQI)
- Brief Fatigue Inventory (BFI)
- HADS
- Global assessment scale
- Hot flash frequency and severity
- Acupuncture expectancy scale
- Credibility rating of acupuncture