Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	NCCTG-N01C5 N01C5, NCT00075842

Objectives

Primary

1. Determine the effect of Valeriana officinalis (Valerian) for improving the quality of sleep in patients with cancer receiving adjuvant therapy.

Secondary

1. Determine the safety of this therapy, in terms of frequency and severity of adverse events, in these patients.
2. 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

A total of 220 patients (110 per treatment arm) will be accrued for this study within approximately 11-22 months.

Outcomes

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
James Mailliard, MD, Protocol co-chair		Ph: 402-280-4364 Email: jamailliard@mrcc.cc
Debra Barton, RN, PhD, AOCN, FAAN, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Timothy Morgenthaler, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Brent Bauer, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
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
Trial Start Date		2003-08-22
Trial Completion Date		2007-03-09 (estimated)
Registered in ClinicalTrials.gov		NCT00075842
Date Submitted to PDQ		2003-12-09
Information Last Verified		2009-01-13

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