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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

Phase 3
18 Years
Not Enrolling
Fatigue, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



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


- 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.

Inclusion Criteria


- 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

- Patients receiving intended curative treatment without future planned surgery (i.e.,
prostate cancer patients receiving radiotherapy followed by hormonal therapy) are

- 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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 6 months


- Not specified


- SGOT ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 1.5 times ULN


- Not specified


- 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)


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- See Disease Characteristics


- See Disease Characteristics


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks

Safety Issue:


Principal Investigator

Charles L. Loprinzi, MD

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Fatigue
  • Sleep Disorders
  • Unspecified Adult Solid Tumor, Protocol Specific
  • sleep disorders
  • unspecified adult solid tumor, protocol specific
  • fatigue
  • Fatigue
  • Sleep Disorders
  • Parasomnias



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