Fatigue, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
sleep disorders, unspecified adult solid tumor, protocol specific, fatigue
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.
Interventions
DIETARY_SUPPLEMENTValeriana officinalis extract
Given orally
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Hepatic * SGOT ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 1.5 times ULN 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks | at 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity by questionnaires weekly and CTC grading every 2 weeks | Up to 2 weeks post-treatment |
Countries
United States
Outcome results
None listed