|
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors 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 Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors conditions. Clinical Trials Search.org is a website committed 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 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 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 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 Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors 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 > 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 Quality Of Life Studies:
1. Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue
2. D-MPH in the treatment of fatigue and neurobehavioral function related to chemotherapy in adult cancer patients
3. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
4. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
5. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
Related Studies:
Other Quality of Life Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
|
|
|
|
|
|
|
|
