|
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer conditions. Clinical Trials Search.org is a website committed 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally 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 typically receive the most expert healthcare available for their Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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:
1. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
2. Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases
3. Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy
Related Studies:
Other adult brain tumor Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
|
|
|
|
|
|
|
|
