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Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy Clinical research trials and Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy. Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy clinical trial. Participants oftentimes recieve the most expert healthcare available for their Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy  Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
For Condition: unspecified adult solid tumor, protocol specific,Sleep Disorders,Fatigue
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase III trial to determine the effectiveness of valerian in improving the quality of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or hormone therapy) for cancer.
Details: OBJECTIVES: Primary - Determine the effect of (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 (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 (Valerian) for an additional 8 weeks and patients in arm II may cross over to arm I. 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. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - 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 (Valerian) for sleep - More than 1 month since other prior sleeping-aid medication - No concurrent benzodiazepines
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrentBauer, , Mayo Clinic Cancer Center
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Anthony Jaslowski 920-884-3135
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
Additional Information:
Study ID Numbers: CDR0000349424; NCCTG-N01C5
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075842
Other Fatigue Studies:
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2. Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
3. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
4. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
5. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
Related Studies:
Other Fatigue Clinical Trials
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Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy
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