A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy
| Autor: | L. Douglas Case, George Sanders, Edward G. Shaw, Patricia C. Griffin, Glenn J. Lesser, Kevin P. McMullen, Jerome M. Butler, Michelle J. Naughton, Bart Frizzell, James N. Atkins, Stephen R. Rapp, Richard P. McQuellon, Volker W. Stieber |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Patient Dropouts medicine.medical_treatment Brain tumor Placebo law.invention Cognition Quality of life Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Least-Squares Analysis Prospective cohort study Fatigue Aged Aged 80 and over Analysis of Variance Radiation business.industry Brain Neoplasms Middle Aged medicine.disease Surgery Radiation therapy Clinical trial Oncology Methylphenidate Quality of Life Central Nervous System Stimulants Female business Neurocognitive |
| Zdroj: | International journal of radiation oncology, biology, physics. 69(5) |
| ISSN: | 0360-3016 |
| Popis: | Purpose The quality of life (QOL) and neurocognitive function of patients with brain tumors are negatively affected by the symptoms of their disease and brain radiation therapy (RT). We assessed the effect of prophylactic d-threo-methylphenidate HCl (d-MPH), a central nervous system (CNS) stimulant on QOL and cognitive function in patients undergoing RT. Methods and Materials Sixty-eight patients with primary or metastatic brain tumors were randomly assigned to receive d-MPH or placebo. The starting dose of d-MPH was 5 mg twice daily (b.i.d.) and was escalated by 5 mg b.i.d. to a maximum of 15 mg b.i.d. The placebo was administered as one pill b.i.d. escalating three pills b.i.d. The primary outcome was fatigue. Patients were assessed at baseline, the end of radiation therapy, and 4, 8, and 12 weeks after brain RT using the Functional Assessment of Cancer Therapy with brain and fatigue (FACIT-F) subscales, as well as the Center for Epidemiologic Studies Scale and Mini-Mental Status Exam. Results The Mean Fatigue Subscale Score at baseline was 34.7 for the d-MPH arm and 33.3 for the placebo arm (p = 0.61). At 8 weeks after the completion of brain RT, there was no difference in fatigue between patient groups. The adjusted least squares estimate of the Mean Fatigue Subscale Score was 33.7 for the d-MPH and 35.6 for the placebo arm (p = 0.64). Secondary outcomes were not different between the two treatment arms. Conclusions Prophylactic use of d-MPH in brain tumor patients undergoing RT did not result in an improvement in QOL. |
| Databáze: | OpenAIRE |
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