NCT00075842已完成3 期
The Use Of Valeriana Officinalis (Valerian) In Improving Sleep In Patients Who Are Undergoing Adjuvant Treatment For Cancer" A Phase III Randomized, Placebo-Controlled, Double-Blind Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 33
- 主要终点
- Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
研究概览
简要总结
RATIONALE: The herb Valeriana officinalis (valerian) may promote sleep. It is not yet known whether valerian is effective in improving sleep in patients who are receiving adjuvant therapy for cancer.
PURPOSE: This randomized phase III trial is studying how well valerian improves the quality of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or hormone therapy) for cancer.
详细描述
OBJECTIVES:
Primary
- Determine the effect of Valeriana officinalis (Valerian) for improving the quality of sleep in patients with cancer receiving adjuvant therapy.
Secondary
- Determine the safety of this therapy, in terms of frequency and severity of adverse events, in these patients.
- Determine the effect of this therapy on the degree of anxiety, fatigue, and activities of daily living in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cancer
- •Receiving adjuvant therapy, including any of the following:
- •Radiotherapy
- •Parenteral chemotherapy
- •Oral drugs
- •Hormonal therapy
- •Previously resected tumor, microscopic disease, or nodal or margin involvement allowed
- •Patients receiving intended curative treatment without future planned surgery (i.e., prostate cancer patients receiving radiotherapy followed by hormonal therapy) are eligible
- •Reports difficulty sleeping and seeking therapeutic intervention
- •Defined as a score over 3 on the numerical analogue scale
- •No obstructive sleep apnea
- •No prior diagnosis of primary insomnia per DSM IV criteria
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •SGOT ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No chronic symptom that consistently interrupts sleep (e.g., hot flashes, unmanaged pain, or diarrhea)
- •PRIOR CONCURRENT THERAPY:
- •No prior Valeriana officinalis (Valerian) for sleep
- •More than 1 month since other prior prescription sleeping-aid medication
- •No concurrent benzodiazepines except as short-term treatment for nausea
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.
干预措施: Valeriana officinalis extract (Dietary Supplement)
Arm II
Placebo Comparator
Patients receive an oral placebo once daily for 8 weeks.
干预措施: placebo (Other)
结局指标
主要结局
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
时间窗: at 6 weeks
次要结局
- Toxicity by questionnaires weekly and CTC grading every 2 weeks(Up to 2 weeks post-treatment)
研究者
研究点 (33)
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