Status:
COMPLETED
(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fatigue
Sleep Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. ...
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 safe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00075842
Start Date
August 1 2003
End Date
January 1 2010
Last Update
December 6 2016
Active Locations (33)
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1
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
2
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
3
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
4
Porter Adventist Hospital
Denver, Colorado, United States, 80210