NCT00075842CompletedPhase 3
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
Alliance for Clinical Trials in Oncology66 sites in 1 country227 target enrollmentStarted: August 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 227
- Locations
- 66
- Primary Endpoint
- Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
Time Frame: at 6 weeks
Secondary Outcomes
- Toxicity by questionnaires weekly and CTC grading every 2 weeks(Up to 2 weeks post-treatment)
Investigators
Study Sites (66)
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