(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
This study has been completed.
Sponsor:
North Central Cancer Treatment Group
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
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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 May 23, 2013