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
18 Years
N/A
Both
Fatigue, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
Safety Issue:
No
Principal Investigator
Charles L. Loprinzi, MD
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000349424
NCT ID:
NCT00075842
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
Name | Location |
|---|---|
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
| Boulder Community Hospital | Boulder, Colorado 80301-9019 |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
| CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
| Porter Adventist Hospital | Denver, Colorado 80210 |
| Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
| St. Joseph Hospital | Denver, Colorado 80218 |
| Rose Medical Center | Denver, Colorado 80220 |
| Swedish Medical Center | Englewood, Colorado 80110 |
| Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
| Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
| St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
| North Suburban Medical Center | Thornton, Colorado 80229 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
| Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
| HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
| HealthEast Cancer Care at St. Joseph's Hospital | St Paul, Minnesota 55102 |
| United Hospital | St. Paul, Minnesota 55102 |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury, Minnesota 55125 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
