A Phase III, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial of d-Threo-Methylphenidate HCl in Brain Tumor Patients Receiving Radiation Therapy

Jerome M. Butler, L. Douglas Case, James Atkins, Bart Frizzell, George Sanders, Patricia Griffin, Glenn Lesser, Kevin McMullen, Richard McQuellon, Michelle Naughton, Stephen Rapp, Volker Stieber, Edward G. Shaw

Research output: Contribution to journalArticle

133 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1496-1501
Number of pages6
JournalInternational Journal of Radiation Oncology Biology Physics
Volume69
Issue number5
DOIs
StatePublished - Dec 1 2007
Externally publishedYes

Fingerprint

Methylphenidate
Brain Neoplasms
brain
radiation therapy
Radiotherapy
tumors
Randomized Controlled Trials
Fatigue
Placebos
Quality of Life
central nervous system stimulants
Brain
Central Nervous System Stimulants
Brain Diseases
Least-Squares Analysis
Cognition
Epidemiologic Studies
therapy
cancer
dosage

Keywords

  • Cognitive function
  • Fatigue
  • Methylphenidate
  • Quality of life
  • Radiation therapy

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation

Cite this

A Phase III, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial of d-Threo-Methylphenidate HCl in Brain Tumor Patients Receiving Radiation Therapy. / Butler, Jerome M.; Case, L. Douglas; Atkins, James; Frizzell, Bart; Sanders, George; Griffin, Patricia; Lesser, Glenn; McMullen, Kevin; McQuellon, Richard; Naughton, Michelle; Rapp, Stephen; Stieber, Volker; Shaw, Edward G.

In: International Journal of Radiation Oncology Biology Physics, Vol. 69, No. 5, 01.12.2007, p. 1496-1501.

Research output: Contribution to journalArticle

Butler, JM, Case, LD, Atkins, J, Frizzell, B, Sanders, G, Griffin, P, Lesser, G, McMullen, K, McQuellon, R, Naughton, M, Rapp, S, Stieber, V & Shaw, EG 2007, 'A Phase III, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial of d-Threo-Methylphenidate HCl in Brain Tumor Patients Receiving Radiation Therapy', International Journal of Radiation Oncology Biology Physics, vol. 69, no. 5, pp. 1496-1501. https://doi.org/10.1016/j.ijrobp.2007.05.076
Butler, Jerome M. ; Case, L. Douglas ; Atkins, James ; Frizzell, Bart ; Sanders, George ; Griffin, Patricia ; Lesser, Glenn ; McMullen, Kevin ; McQuellon, Richard ; Naughton, Michelle ; Rapp, Stephen ; Stieber, Volker ; Shaw, Edward G. / A Phase III, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial of d-Threo-Methylphenidate HCl in Brain Tumor Patients Receiving Radiation Therapy. In: International Journal of Radiation Oncology Biology Physics. 2007 ; Vol. 69, No. 5. pp. 1496-1501.
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AU - Case, L. Douglas

AU - Atkins, James

AU - Frizzell, Bart

AU - Sanders, George

AU - Griffin, Patricia

AU - Lesser, Glenn

AU - McMullen, Kevin

AU - McQuellon, Richard

AU - Naughton, Michelle

AU - Rapp, Stephen

AU - Stieber, Volker

AU - Shaw, Edward G.

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N2 - 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.

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