NCT00879164已完成1 期
Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference in hot flash activity between baseline and week 7
研究概览
简要总结
RATIONALE: A stellate ganglion nerve block may help relieve hot flashes in women.
PURPOSE: This clinical trial is studying how well a stellate ganglion nerve block works in treating women with hot flashes.
详细描述
OBJECTIVES:
- To evaluate the impact of stellate ganglion blockade on hot flash scores.
- To evaluate the toxicity of stellate ganglion blockade.
OUTLINE: Patients undergo fluoroscopic-guided stellate ganglion blockade using bupivacaine hydrochloride in week 1.
Patients complete a hot flash diary daily and a symptom experience diary weekly in weeks 1-7 and the Profile of Mood States questionnaire in weeks 1 and 7.
After completion of study treatment, patients are followed at 2 months and then monthly for 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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
- •DISEASE CHARACTERISTICS:
- •Presence of hot flashes for ≥ 1 month prior to study registration
- •Hot flashes considered bothersome (defined by their occurrence of ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
- •Use of more conventional hot flash treatments (including newer antidepressants and gabapentin) have failed to control hot flashes (as defined by the patient)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy ≥ 6 months
- •Not of childbearing potential, as judged by the attending clinician
- •Able to complete questionnaires alone or with assistance
- •No evidence of an active malignancy
- •No von Willebrand's disease or other bleeding disorders
- •No allergy to chlorhexidine or bupivacaine
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents
- •Tamoxifen, raloxifene, or aromatase inhibitors allowed provided the patient has been on a constant dose for ≥ 4 weeks and continues to receive medication during study treatment
- •More than 10 days since prior and no concurrent anticoagulants (e.g., aspirin, clopidogrel, ticlopidine, or warfarin)
- •Concurrent heparin flushes for venous catheter allowed
- •No concurrent use of other agents (e.g., megestrol acetate, soy, clonidine, or Bellergal) for treating hot flashes
- •Vitamin E, gabapentin, or antidepressants allowed provided the patient has been on a stable dose for > 30 days and continues to receive medication during study treatment
排除标准
- 未提供
结局指标
主要结局
Difference in hot flash activity between baseline and week 7
次要结局
- Difference in quality of life, toxicity, and self-assessment items between baseline and week 7
研究者
研究点 (1)
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