Clinical Trial: Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy

This study is currently recruiting patients.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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: Randomized phase III trial to determine the effectiveness of valerian in improving the quality of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or hormone therapy) for cancer.

Condition Treatment or Intervention Phase
Sleep Disorders
unspecified adult solid tumor, protocol specific
Fatigue
 Drug: Valeriana officinalis
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: complications of therapy assessment/management
 Procedure: fatigue assessment/management
 Procedure: herbal medicine / botanical therapy
 Procedure: sleep disorders therapy
 Procedure: supportive care/therapy
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Sleep Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy

Further Study Details: 

OBJECTIVES: Primary

  • Determine the effect of (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.

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 (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 (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.

Patients are followed weekly for 2 weeks to assess withdrawal symptoms.

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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
  • 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

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)

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 (Valerian) for sleep
  • More than 1 month since other prior prescription sleeping-aid medication
  • No concurrent benzodiazepines except as short-term treatment for nausea

Location and Contact Information


Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Tom Robert Fitch, MD  480-301-9875 

Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Edith A. Perez, MD  904-953-7283    perez.edith@mayo.edu 

Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
Martin Wiesenfeld, MD  319-363-8303 

      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-244-7586 

      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Donald Bruce Wender, MD, PhD  712-252-0088    shoaresearch@shoa-research.org 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
Daniel Nikcevich, MD, PhD  218-786-3625    dnikcevich@smdc.org 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Brent A. Bauer, MD  507-284-2511    bauer.brent@mayo.edu 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

Ohio
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
Paul L. Schaefer, MD  419-843-6147 

South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
James Dewitt Bearden, MD  864-560-7050 

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8044    tidemanb@siouxvalley.org 

Study chairs or principal investigators

Charles L. Loprinzi, MD,  Mayo Clinic Cancer Center   
James A. Mailliard, MD,  CCOP - Missouri Valley Cancer Consortium   
Debra Barton, RN, PhD,  Mayo Clinic Cancer Center   
Timothy I. Morgenthaler, MD,  Study Chair,  Mayo Clinic Cancer Center   
Brent A. Bauer, MD,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000349424; NCCTG-N01C5; NCT00075842
Record last reviewed:  January 2005
Last Updated:  April 4, 2005
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075842
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005