Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information
Valeriana officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Supportive care | Completed | 18 and over | NCI | NCCTG-N01C5 N01C5, NCT00075842 |
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.
Entry Criteria
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
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
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
Patient Characteristics:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- SGOT ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 times ULN
Renal
- Not specified
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)
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
and CTC grading every 2 weeks
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.
Published ResultsBarton DL, Atherton PJ, Bauer BA, et al.: The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: a phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5). J Support Oncol 9 (1): 24-31, 2011 Jan-Feb.[PUBMED Abstract]
Trial Lead Organizations
North Central Cancer Treatment Group
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| Charles Loprinzi, MD, Protocol co-chair | |
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| James Mailliard, MD, Protocol co-chair | |
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| Debra Barton, RN, PhD, AOCN, FAAN, Protocol co-chair | |
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| Timothy Morgenthaler, MD, Protocol chair | |
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| Brent Bauer, MD, Protocol co-chair | |
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| Registry Information | ||
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| Official Title | 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 | |
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| Trial Start Date | 2003-08-22 | |
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| Trial Completion Date | 2010-01-29 | |
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| Registered in ClinicalTrials.gov | NCT00075842 | |
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| Date Submitted to PDQ | 2003-12-09 | |
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| Information Last Verified | 2009-01-13 | |
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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