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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075842
First received: January 9, 2004
Last updated: April 6, 2011
Last verified: January 2009
  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: This randomized phase III trial is studying how well valerian improves the quality of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or hormone therapy) for cancer.


Condition Intervention Phase
Fatigue
Sleep Disorders
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: Valeriana officinalis extract
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity by questionnaires weekly and CTC grading every 2 weeks [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: August 2003
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.
Dietary Supplement: Valeriana officinalis extract
Given orally
Placebo Comparator: Arm II
Patients receive an oral placebo once daily for 8 weeks.
Other: placebo
Given orally

Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075842

Locations
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
St. Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Swedish Medical Center
Englewood, Colorado, United States, 80110
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
United States, Iowa
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
HealthEast Cancer Care at St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
United Hospital
St. Paul, Minnesota, United States, 55102
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Investigator: Charles L. Loprinzi, MD Mayo Clinic
Investigator: James A. Mailliard, MD CCOP - Missouri Valley Cancer Consortium
Investigator: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
Study Chair: Timothy I. Morgenthaler, MD Mayo Clinic
Investigator: Brent A. Bauer, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Charles L. Loprinzi, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00075842     History of Changes
Other Study ID Numbers: CDR0000349424, NCCTG-N01C5
Study First Received: January 9, 2004
Last Updated: April 6, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
sleep disorders
unspecified adult solid tumor, protocol specific
fatigue

Additional relevant MeSH terms:
Fatigue
Sleep Disorders
Parasomnias
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014