(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to type of adjuvant treatment (radiotherapy vs parenteral chemotherapy vs oral therapy vs combined modality), age (40 and under vs 41 to 55 vs 56 to 70 vs over 70), and numerical analogue scale for sleep difficulty (mildly impaired sleep quality [4-7] vs moderate or severely impaired sleep quality [8-10]). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks. Arm II: Patients receive an oral placebo once daily for 8 weeks. After 8 weeks of treatment, patients in arm I may receive Valeriana officinalis (Valerian) for an additional 8 weeks and patients in arm II may cross over to arm I. Pittsburgh Sleep Quality Index, functional outcomes of sleep, brief fatigue inventory, and profile of mood states questionnaires are completed at baseline and then at weeks 4, 8, 12, and 16. After completion of study treatment, patients are followed weekly for 2 weeks. PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within approximately 11-22 months.

Official Title
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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

Conditions
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Fatigue, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Dietary Supplement: Valeriana officinalis extract
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 6 months Hepatic SGOT ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 1.5 times ULN Other 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: Other 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks. | Dietary Supplement: Valeriana officinalis extract<br>* Given orally<br>|
| Placebo Comparator: Arm II<br>Patients receive an oral placebo once daily for 8 weeks. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks |  | at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity by questionnaires weekly and CTC grading every 2 weeks |  | Up to 2 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep disorders, unspecified adult solid tumor, protocol specific, fatigue