Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 650-662 , November 2009

Efficacy of Dexmethylphenidate for the Treatment of Fatigue After Cancer Chemotherapy: A Randomized Clinical Trial

  • Elyse E. Lower, MD

      Affiliations

    • University of Cincinnati Medical Center, Cincinnati, Ohio, USA
    • Corresponding Author InformationAddress correspondence to: Elyse E. Lower, MD, University of Cincinnati Medical Center, Albert Sabin Way, 1001 Holmes, Cincinnati, OH 45267-0565, USA.
  • ,
  • Stewart Fleishman, MD

      Affiliations

    • Continuum Cancer Centers of New York, Beth Israel Medical Center & St. Luke's-Roosevelt Hospital Center, New York, New York, USA
  • ,
  • Alyse Cooper, MBA

      Affiliations

    • Celgene Corporation, Summit, New Jersey, USA
  • ,
  • Jerome Zeldis, MD, PhD

      Affiliations

    • Celgene Corporation, Summit, New Jersey, USA
  • ,
  • Herbert Faleck, DO

      Affiliations

    • Celgene Corporation, Summit, New Jersey, USA
  • ,
  • Zhinuan Yu, PhD

      Affiliations

    • Celgene Corporation, Summit, New Jersey, USA
  • ,
  • Donald Manning, MD, PhD

      Affiliations

    • Celgene Corporation, Summit, New Jersey, USA

,Accepted 1 April 2009.

References 

  1. Mock V, Atkinson A, Barsevick A, et al. NCCN practice guidelines for cancer-related fatigue. Oncology. 2000;14(11A):151–161
  2. Curt GA, Breitbart W, Cella D, et al. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5:353–360
  3. Vogelzang NJ, Breitbart W, Cella D, et al. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol. 1997;34(3 Suppl 2):4–12
  4. Wefel JS, Lenzi R, Theriault R, et al. ‘Chemobrain’ in breast carcinoma?: a prologue. Cancer. 2004;101:466–475
  5. Tannock IF, Ahles TA, Ganz PA, Van Dam FS. Cognitive impairment associated with chemotherapy for cancer: report of a workshop. J Clin Oncol. 2004;22:2233–2239
  6. Mar Fan HG, Houédé-Tchen N, Yi QL, et al. Fatigue, menopausal symptoms, and cognitive function in women after adjuvant chemotherapy for breast cancer: 1- and 2-year follow-up of a prospective controlled study. J Clin Oncol. 2005;23:8025–8032
  7. Kibiger G, Kirsh KL, Wall JR, Passik SD. My mind is as clear as it used to be: a pilot study illustrating the difficulties of employing a single-item subjective screen to detect cognitive impairment in outpatients with cancer. J Pain Symptom Manage. 2003;26:705–715
  8. Bruera E, Driver L, Barnes EA, et al. Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. J Clin Oncol. 2003;21:4439–4443
  9. Schwartz AL, Thompson JA, Masood N. Interferon-induced fatigue in patients with melanoma: a pilot study of exercise and methylphenidate. Oncol Nurs Forum. 2002;29:E85–E90
  10. Mulhern RK, Khan RB, Kaplan S, et al. Short-term efficacy of methylphenidate: a randomized, double-blind, placebo-controlled trial among survivors of childhood cancer. J Clin Oncol. 2004;22:4795–4803
  11. Meyers CA, Weitzner MA, Valentine AD, Levin VA. Methylphenidate therapy improves cognition, mood, and function of brain tumor patients. J Clin Oncol. 1998;16:2522–2527
  12. Patrick KS, Caldwell RW, Ferris RM, Breese GR. Pharmacology of the enantiomers of threo-methylphenidate. J Pharmacol Exp Ther. 1987;241:152–158
  13. Ding YS, Gatley SJ, Thanos PK, et al. Brain kinetics of methylphenidate (Ritalin) enantiomers after oral administration. Synapse. 2004;53:168–175
  14. Volkow ND, Fowler JS, Wang G, Ding Y, Gatley SJ. Mechanism of action of methylphenidate: insights from PET imaging studies. J Atten Disord. 2002;6(Suppl 1):S31–S43
  15. Ding YS, Fowler JS, Volkow ND, et al. Chiral drugs: comparison of the pharmacokinetics of [11C]d-threo and l-threo-methylphenidate in the human and baboon brain. Psychopharmacology. 1997;131:71–78
  16. Quinn D, Wigal S, Swanson J, et al. Comparative pharamcodynamics and plasma concentrations of d-threo-methylphenidate hydrochloride after single doses of d-threo-methylphenidate hydrochloride and d, l-threo-methylphenidate hydrochloride in a double-blind, placebo-controlled, crossover laboratory school study in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2004;43:1422–1429
  17. Weiss M, Wasdell M, Patin J. A post hoc analysis of d-threo-methylphenidate hydrochloride (Focalin) versus d, l-threo-methylphenidate hydrochloride (ritalin). J Am Acad Child Adolesc Psychiatry. 2004;43:1415–1421
  18. Wigal S, Swanson JM, Feifel D, et al. A double-blind, placebo-controlled trial of dexmethylphenidate hydrochloride and d,l-threo-methylphenidate hydrochloride in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2004;43:1406–1414
  19. Cella D, Davis K, Breitbart W, Curt G, for the Fatigue Coalition . Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. J Clin Oncol. 2001;19:3385–3391
  20. Faust D, Fogel BS. The development and initial validation of a sensitive bedside cognitive screening test. J Nerv Ment Dis. 1989;177:25–31
  21. Beck AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: twenty-five years of evaluation. Clin Psychol Rev. 1988;8:77–100
  22. National Institute of Mental Health . Clinical global impressions. In:  Bonato RR,  Guy W editor. revised ed. Manual for the ECDEU assessment battery-2. 12:Bethesda, MD: National Institute of Mental Health; 1970;p. 112–116
  23. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the functional assessment of cancer therapy (FACT) measurement system. J Pain Symptom Manage. 1997;13:63–74
  24. Tchen N, Juffs HG, Downie FP, et al. Cognitive function, fatigue, and menopausal symptoms in women receiving adjuvant chemotherapy for breast cancer. J Clin Oncol. 2003;21:4175–4183
  25. Brezden CB, Phillips KA, Abdollel M, Bunston T, Tannock IF. Cognitive function in breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol. 2000;18:2695–2701
  26. Koch GG, Gitmer SL, Skalland L, Stokes ME. Some non-parametric and categorical data analyses for a change-over design study and discussion of apparent carry-over effects. Stat Med. 1983;2:397–412
  27. Reddy SG, Pace E, Zhang T, Bruera E. What is a clinically significant improvement in the intensity of fatigue among cancer patients?. Proceedings of the ASCO Annual Meeting J Clin Oncol. 2006;24(18S):Abstract No: 8560
  28. Reddy S, Bruera E, Pace E, Zhang K, Reyes-Gibby CC. Clinically important improvement in the intensity of fatigue in patients with advanced cancer. J Palliat Med. 2007;10:1068–1075
  29. Bruera E, Valero V, Driver L, et al. Patient-controlled methylphenidate for cancer fatigue: a double-blind, randomized, placebo-controlled trial. J Clin Oncol. 2006;24:2073–2078

 This study was supported by investigator grants to E. E. L. and S. F. from the sponsor, Celgene Corporation. Novartis Corporation, East Hanover, NJ, supplied the study drug.

 Presented as an abstract (No. 8000) at the 2005 American Society of Clinical Oncology Annual Meeting, and as a poster presentation (No. 5026) at the 2005 San Antonio Breast Cancer Symposium Annual Meeting.

PII: S0885-3924(09)00729-5

doi: 10.1016/j.jpainsymman.2009.03.011

Journal of Pain and Symptom Management
Volume 38, Issue 5 , Pages 650-662 , November 2009