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Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer Clinical research trials and Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer  Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
For Condition: unspecified adult solid tumor, protocol specific,Fatigue
Status: Recruiting
Sponsor(s): University of Rochester , National Cancer Institute (NCI)
Synopsis: RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: Randomizedphase III trial to determine the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
Details: OBJECTIVES: - Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy. - Assess the relationship between depression and fatigue in patients treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Beginning on day 10 of the second course of chemotherapy, patients receive oral modafinil once daily. - Arm II: Beginning on day 10 of the second course of chemotherapy, patients receive oral placebo once daily. Treatment is temporarily discontinued for 3 days during courses 3 and 4 of chemotherapy (i.e., the days before, during, and after chemotherapy). Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity. Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy. PROJECTED ACCRUAL: A total of 837 patients will be accrued for this study within approximately 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of cancer - Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy - Each course of chemotherapy must be at least 2 weeks in duration - No concurrent radiotherapy or interferon therapy - Brief Fatigue Inventory question #3 "fatigue worst" score of 2 or greater 1 week after first chemotherapy course PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - At least 6 months Hematopoietic - Not specified Hepatic - No uncontrolled anemia Renal - Not specified Cardiovascular - No history of clinically significant cardiac disease - No uncontrolled hypertension Gastrointestinal - Able to swallow medication - No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract Other - No severe headaches - No glaucoma - No seizure disorder - No narcolepsy - No psychotic disorder - No Tourette's syndrome - No alcohol or drug abuse - Not pregnant or nursing - Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No concurrent interferon alfa or interleukin-2 Chemotherapy - See Disease Characteristics Endocrine therapy - Concurrent oral or IV corticosteroids, such as dexamethasone or prednisolone, used to enhance effects of antiemetics allowed - No other concurrent chronic corticosteroids Radiotherapy - See Disease Characteristics Surgery - Not specified Other - No prior modafinil - At least 30 days since prior investigational drugs - At least 30 days since prior anticonvulsants (e.g., phenytoin), psychostimulants (e.g., amphetamines or methylphenidate), pemoline, or monoamine oxidase inhibitors (MAOIs) - Concurrent low-dose warfarin for maintenance of venous access devices allowed - No concurrent alcohol - Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryMorrow, Study Chair, James P. Wilmot Cancer Center
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
St. Joseph Hospital *Recruiting*
Denver, Colorado, 80218-1191
United States
Recruiting Michael McLaughlin 303-861-3302
St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo, Colorado, 81004
United States
Recruiting Marlow Sloan 719-560-6000
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting David Trevarthen 303-788-8675
Penrose Cancer Center *Recruiting*
Colorado Springs, Colorado, 80933
United States
Recruiting Robert Sayre 719-577-2555
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-435-3941
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6600
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1677
Longmont United Hospital *Recruiting*
Longmont, Colorado, 80501
United States
Recruiting Robert Fisher 303-485-4132
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Scot Sedlacek 303-321-0302
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Presbyterian-St Luke's Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Jotte 303-388-4876
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
Swedish Medical Center *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Marshall Davis 303-788-5860
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 612-863-8585
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-832-1093
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Boulder Community Hospital *Recruiting*
Boulder, Colorado, 80301-9019
United States
Recruiting John Fleagle 303-440-2399
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5900
Rocky Mountain Cancer Centers *Recruiting*
Thornton, Colorado, 80260
United States
Recruiting Alvin Otsuka 303-386-7622
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Medical Center of Aurora - South Campus *Recruiting*
Aurora, Colorado, 80012-0000
United States
Recruiting Sami Diab 303-418-7600
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Sky Ridge Medical Center *Recruiting*
Lone Tree, Colorado, 80124
United States
Recruiting Dennis Carter 720-225-4211
Additional Information:
Study ID Numbers: CDR0000069477; URCC-U2901,NCI-P02-0228,NCI-5952
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042848
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
2. Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
3. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
4. Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
5. Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Colorado Clinical Trials
Other Pueblo Clinical Trials
Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
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