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Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy Clinical research trials and Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy. Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy clinical trial. Test subjects typically receive the most effective healthcare possible for their Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy  Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy
Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy
For Condition: unspecified adult solid tumor, protocol specific,Fatigue,cognitive/functional effects
Status: Completed
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Dexmethylphenidate may be effective in relieving fatigue and improving neurobehavioral changes such as loss of concentration and memory in patients with cancer who have received chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of dexmethylphenidate in treating patients who have fatigue and neurobehavioral changes after undergoing chemotherapy.
Details: OBJECTIVES: - Determine the efficacy of dexmethylphenidate, in terms of reduced fatigue and improved neurobehavioral function, in cancer patients with chemotherapy-induced fatigue and neurobehavioral impairment. - Determine the safety of this drug in these patients. - Determine the efficacious dose range required to maintain the effectiveness of this drug in these patients. OUTLINE: This is a randomized, single- and double-blind, placebo-controlled, parallel-group, multicenter study. Treatment is divided into single-blind prerandomization and double-blind treatment phases. - Patients receive oral study drug twice daily for 7 days. Patients complete the Clinical Global Impression and Clinical Global Impression-Improvement scales at baseline and at completion of the pre-randomization phase. Patients with no improvement on these scales proceed to the double-blind treatment phase. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral dexmethylphenidate twice daily. - Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity. Patients in both arms complete efficacy assessments at baseline, weekly during treatment, and at end of treatment. PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of cancer - No primary or metastatic brain tumors - At least 4 prior courses of cytotoxic chemotherapy - No more than 2 months since completion of chemotherapy - Absence of a focal neurological deficit by physical and neurological examination - Must meet all of the following parameters: - Cancer-related fatigue (CRF) as determined by International Classification of Disease-10 Criteria for CRF - Score of at least 20 on Mini-Mental Status Exam - Score less than 18 on Beck Depression Inventory-II - Score of at least 3 on Clinical Global Impression-Severity PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - ECOG 0-2 Life expectancy - More than 6 months Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Neurologic - No history of seizure disorder - No severe mental impairment that would preclude study compliance - No major psychiatric illness (e.g., suicidal ideation) that would preclude study - None of the following: - Attention-deficit disorder - Learning disabilities - Special education support Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of drug or alcohol abuse - Able to speak and understand English - At least 8^th-grade education - No concurrent symptoms of menopause - No other concurrent severe acute or chronic medical condition that would preclude study - No medical contraindication to the use of dexmethylphenidate or methylphenidate, including: - Marked anxiety - Tension - Agitation - Glaucoma - Diagnosis or family history of Tourette's syndrome - Presence of motor or vocal tics PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - No prior prophylactic cranial radiotherapy Surgery - Not specified Other - More than 30 days since prior investigational drugs - No prior dexmethylphenidate - No prior methylphenidate - More than 30 days since prior monoamine oxidase inhibitors (MAOIs) - No concurrent MAOIs - No concurrent opioids or narcotic-like drugs - Concurrent antidepressants (e.g., tricyclics, selective serotonin reuptake inhibitors) allowed if dose has been stable for at least the past 6 weeks - No concurrent anticancer therapy - No concurrent new treatment may be initiated after study enrollment - No concurrent stimulant medication (e.g., racemic methylphenidate, d-amphetamine, or mixed amphetamine salts [Adderall])
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGlaspy, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: CDR0000258509; UCLA-0204034,CELGENE-d-MPH-COG-002
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052533
Other Fatigue Studies:
1. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
2. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
3. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
4. Darbepoetin Alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
5. Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer
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Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy
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