Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:
- improve sleep thereby decreasing need for opiates via PCA
- improve sleep thereby decreasing pain by self report
- improve sleep thereby decreasing fatigue by self report
详细描述
Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue.
One of the less commonly recognized side effects of opiate use is sleep disruption.
Experimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli.
Cancer patients requiring chemotherapy commonly require PCA because of oral mucositis. The objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.
- •Age 20 - 75
- •Not currently regularly taking any prescribed sleeping pill more often than 4x/week.
- •Can tolerate oral medication.
排除标准
- •Patients with a current history of substance abuse
- •Patients with a history of allergic response to Lunesta.
- •Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.
研究组 & 干预措施
eszopiclone
active drug
干预措施: Eszopiclone (Drug)
placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pain
时间窗: post dosing
Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").
Patient Self-report Data on Fatigue
时间窗: 2 days post treatment
Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).
次要结局
- Opiate Dosing From Patient Controlled Analgesia(2 days post dosing)
研究者
Joel E. Dimsdale, M.D.
Professor
University of California, San Diego