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Phase III Randomized Study of Valeriana officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
Alternate Title Valeriana officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
Objectives Primary
Secondary
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Patient Characteristics: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Expected Enrollment 220A total of 220 patients (110 per treatment arm) will be accrued for this study within approximately 11-22 months. Outcomes Primary Outcome(s)Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
Toxicity by questionnaires weekly
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.
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. Trial Lead Organizations North Central Cancer Treatment Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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