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

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.

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

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
Ohio
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting

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   

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