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Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors Clinical research trials and Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors. Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors clinical trial. Participants frequently get the best healthcare available for their Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors  Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
For Condition: cognitive and functional effects,Quality of Life,brain metastases,adult brain tumor,Depression,Fatigue
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors. PURPOSE: Randomizedphase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy.
Details: OBJECTIVES: - Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors. - Determine the effect of this drug on the quality of life of these patients. - Determine the effect of this drug on depression in these patients. - Determine the effect of this drug on global neurocognitive function, including attention and concentration, memory, language, visuospatial skills, and executive function, in these patients. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified by tumor type (primary vs metastatic), treatment (radiotherapy vs radiotherapy and chemotherapy), and Karnofsky performance status (70% or 80% vs 90% or 100%). Patients are randomized to one of two treatment arms. All patients undergo radiotherapy over weeks 1-4. - Arm I: Patients receive oral d-methylphenidate twice daily on weeks 1-12. - Arm II: Patients receive oral placebo twice daily on weeks 1-12. In both arms, quality of life is assessed at baseline, at the end of radiotherapy, and at 4, 8, and 12 weeks after radiotherapy. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic brain tumor OR - Histologically confirmed primary brain tumor - Glioblastoma multiforme - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Anaplastic mixed oligoastrocytoma - Low-grade glioma - Meningioma - Ependymoma - Planned external beam cranial radiotherapy (partial or whole brain) with a total dose of at least 25 Gy in at least 10 fractions of 180-300 cGy each PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - WBC 1,500/mm^3 - Hemoglobin 10.0 g/dL - Platelet count 75,000/mm^3 Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No hypertension or other cardiovascular disease requiring antihypertensives and/or other cardiovascular medications Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other serious medical or psychiatric illness that would preclude study participation - No hypersensitivity to study drug - No history of steroid psychosis - No family history of or active Tourette's Syndrome - No prior or active glaucoma PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior or concurrent chemotherapy allowed Endocrine therapy: - Concurrent steroids allowed Radiotherapy: - See Disease Characteristics - Prior radiotherapy allowed except to brain (including stereotactic radiosurgery) - No concurrent craniospinal axis radiotherapy Surgery: - Not specified Other: - No prior or concurrent medications for attention deficit disorder, anxiety disorder, schizophrenia, or substance abuse - No concurrent anti-depressants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardShaw, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
Additional Information:
Study ID Numbers: CDR0000069227; NCI-P02-0211,CCCWFU-97600
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031798
Other Cognitive And Functional Effects Studies:
1. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
2. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
3. Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy
4. Methylphenidate in Treating Patients With Melanoma
5. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
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Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
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