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Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain 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 and Behavioral Change in Patients With Primary Brain Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer Clinical research trials and Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain 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 and Behavioral Change in Patients With Primary Brain Cancer. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain 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 and Behavioral Change in Patients With Primary Brain Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain 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 and Behavioral Change in Patients With Primary Brain Cancer  Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
For Condition: adult brain tumor,Fatigue,cognitive/functional effects
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known. PURPOSE: Randomized clinical trial to determine the effectiveness of modafinil in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
Details: OBJECTIVES: - Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors. - Determine the safety of this drug in these patients. - Compare quality of life of patients treated with 2 different doses of this drug. OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms. - Arm I: Patients receive oral high-dose modafinil twice daily. - Patients receive oral low-dose modafinil twice daily. In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period. - Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses. Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program - Nonmalignant cerebral tumors also allowed - Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy - Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale PATIENT CHARACTERISTICS: Age - 21 to 65 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2.5 times upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 mg/dL Other - Able to speak English - Capable of completing self-rating scales and one-on-one psychometric tests - No severe cognitive impairment - No other terminal illness - No emergency patients - No institutional residents - No prisoners or parolees - No UCLA students or staff - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No concurrent irinotecan - No concurrent participation in UCLA experimental chemotherapy trials - Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed Endocrine therapy - Concurrent glucocorticoids (e.g., dexamethasone) allowed - Concurrent tamoxifen allowed Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics Other - No prior modafinil - At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate) - No concurrent experimental anticancer medication - No concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors - Concurrent anticonvulsants allowed - Concurrent isotretinoin allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyCloughesy, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-6967
United States
Recruiting Thomas Kaleita 310-825-9989
Additional Information:
Study ID Numbers: CDR0000258139; NCI-G02-2133,CEPHALON-UCLA-0206017,UCLA-0206017
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052286
Other Adult Brain Tumor Studies:
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2. Antineoplaston Therapy in Treating Patients With Brain Tumors
3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
4. BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
5. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
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Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
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