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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075842 |
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 |
Drug: Valeriana officinalis extrtact Drug: placebo |
Phase III |
MedlinePlus related topics: | Cancer Sleep Disorders |
ChemIDplus related topics: | Valerian |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
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 |
Estimated Enrollment: | 220 |
Study Start Date: | August 2003 |
Arms | Assigned Interventions |
Arm I: Experimental
Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.
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Drug: Valeriana officinalis extrtact
Given orally
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Arm II: Placebo Comparator
Patients receive an oral placebo once daily for 8 weeks.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Receiving adjuvant therapy, including any of the following:
Reports difficulty sleeping and seeking therapeutic intervention
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Colorado | |||||
Aurora Presbyterian Hospital | |||||
Aurora, Colorado, United States, 80012 | |||||
Boulder Community Hospital | |||||
Boulder, Colorado, United States, 80301-9019 | |||||
CCOP - Colorado Cancer Research Program | |||||
Denver, Colorado, United States, 80224-2522 | |||||
Hope Cancer Care Center at Longmont United Hospital | |||||
Longmont, Colorado, United States, 80502 | |||||
Presbyterian - St. Luke's Medical Center | |||||
Denver, Colorado, United States, 80218 | |||||
Penrose Cancer Center at Penrose Hospital | |||||
Colorado Springs, Colorado, United States, 80933 | |||||
Porter Adventist Hospital | |||||
Denver, Colorado, United States, 80210 | |||||
North Suburban Medical Center | |||||
Thornton, Colorado, United States, 80229 | |||||
Rose Medical Center | |||||
Denver, Colorado, United States, 80220 | |||||
Sky Ridge Medical Center | |||||
Lone Tree, Colorado, United States, 80124 | |||||
St. Joseph Hospital | |||||
Denver, Colorado, United States, 80218 | |||||
St. Mary - Corwin Regional Medical Center | |||||
Pueblo, Colorado, United States, 81004 | |||||
Swedish Medical Center | |||||
Englewood, Colorado, United States, 80110 | |||||
United States, Iowa | |||||
Mercy Cancer Center at Mercy Medical Center - North Iowa | |||||
Mason City, Iowa, United States, 50401 | |||||
Siouxland Hematology-Oncology Associates, LLP | |||||
Sioux City, Iowa, United States, 51101 | |||||
St. Luke's Regional Medical Center | |||||
Sioux City, Iowa, United States, 51104 | |||||
United States, Kansas | |||||
CCOP - Wichita | |||||
Wichita, Kansas, United States, 67214 | |||||
United States, Minnesota | |||||
CCOP - Metro-Minnesota | |||||
Saint Louis Park, Minnesota, United States, 55416 | |||||
Fairview Ridges Hospital | |||||
Burnsville, Minnesota, United States, 55337 | |||||
Fairview Southdale Hospital | |||||
Edina, Minnesota, United States, 55435 | |||||
HealthEast Cancer Care at St. John's Hospital | |||||
Maplewood, Minnesota, United States, 55109 | |||||
HealthEast Cancer Care at St. Joseph's Hospital | |||||
St Paul, Minnesota, United States, 55102 | |||||
HealthEast Cancer Care at Woodwinds Health Campus | |||||
Woodbury, Minnesota, United States, 55125 | |||||
Hennepin County Medical Center - Minneapolis | |||||
Minneapolis, Minnesota, United States, 55415 | |||||
Hutchinson Area Health Care | |||||
Hutchinson, Minnesota, United States, 55350 | |||||
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |||||
Minneapolis, Minnesota, United States, 55407 | |||||
Mercy and Unity Cancer Center at Mercy Hospital | |||||
Coon Rapids, Minnesota, United States, 55433 | |||||
Mercy and Unity Cancer Center at Unity Hospital | |||||
Fridley, Minnesota, United States, 55432 | |||||
Minnesota Oncology Hematology, PA - Maplewood | |||||
Maplewood, Minnesota, United States, 55109 | |||||
Minnesota Oncology Hematology, PA - Woodbury | |||||
Woodbury, Minnesota, United States, 55125 | |||||
St. Francis Cancer Center at St. Francis Medical Center | |||||
Shakopee, Minnesota, United States, 55379 | |||||
United Hospital | |||||
St. Paul, Minnesota, United States, 55102 | |||||
Meeker County Memorial Hospital | |||||
Lichfield, Minnesota, United States, 55355 |
North Central Cancer Treatment Group |
National Cancer Institute (NCI) |
Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
Investigator: | James A. Mailliard, MD | CCOP - Missouri Valley Cancer Consortium |
Investigator: | Debra Barton, RN, PhD | Mayo Clinic |
Study Chair: | Timothy I. Morgenthaler, MD | Mayo Clinic |
Investigator: | Brent A. Bauer, MD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000349424, NCCTG-N01C5 |
First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075842 |
Health Authority: | United States: Federal Government |
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