(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificSleep DisordersFatigue
- Interventions
- Dietary Supplement: Valeriana officinalis extractOther: placebo
- Registration Number
- NCT00075842
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I Valeriana officinalis extract Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks. Arm II placebo Patients receive an oral placebo once daily for 8 weeks.
- Primary Outcome Measures
Name Time Method Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks at 6 weeks
- Secondary Outcome Measures
Name Time Method Toxicity by questionnaires weekly and CTC grading every 2 weeks Up to 2 weeks post-treatment
Trial Locations
- Locations (33)
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
St. Mary - Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
North Suburban Medical Center
🇺🇸Thornton, Colorado, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States