Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy

BJU International

Volumn 116, Issue 5, 2015, Pages 744-752

  Richard, Patrick O ^a   Fleshner, Neil E ^a   Bhatt, Jaimin R ^a   Hersey, Karen M ^a   Chahin, Rehab ^a   Alibhai, Shabbir M H ^a,b  

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

Author keywords

androgen deprivation therapy; fatigue; gonadotropin releasing hormone; methylphenidate; prostate cancer

Indexed keywords

GONADORELIN AGONIST; METHYLPHENIDATE; PLACEBO; ANTIANDROGEN; CENTRAL STIMULANT AGENT; GONADORELIN RECEPTOR;

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; BRUERA GLOBAL FATIGUE SEVERITY SCALE; CANCER FATIGUE; CONTROLLED STUDY; DISEASE SEVERITY ASSESSMENT; DRY SKIN; DYSPEPSIA; FUNCTIONAL ASSESSMENT OF CANCER THERAPY FATIGUE SUBSCALE; FUNCTIONAL STATUS ASSESSMENT; GASTROESOPHAGEAL REFLUX; HUMAN; INSOMNIA; LINEAR REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MOOD DISORDER; NAUSEA; OUTCOME ASSESSMENT; OUTPATIENT DEPARTMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SHORT FORM 36; TREATMENT DURATION; URINARY TRACT INFECTION; AGONISTS; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPLICATION; DOUBLE BLIND PROCEDURE; FATIGUE; PROSTATIC NEOPLASMS; TREATMENT OUTCOME;

ANDROGEN ANTAGONISTS; CENTRAL NERVOUS SYSTEM STIMULANTS; DOUBLE-BLIND METHOD; FATIGUE; HUMANS; MALE; METHYLPHENIDATE; PROSTATIC NEOPLASMS; QUALITY OF LIFE; RECEPTORS, LHRH; TREATMENT OUTCOME;

EID: 84943587529     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/bju.12755     Document Type: Article

References (35)

1. American Cancer Society. Cancer Facts and Figures. Atlanta, GA: American Cancer Society, 2013
2. Canadian Cancer Society. 2013 Cancer Statistics. Toronto, ON: Canadian Cancer Society, 2013
3. Storey DJ, McLaren DB, Atkinson MA, et al. Clinically relevant fatigue in men with hormone-sensitive prostate cancer on long-term androgen deprivation therapy. Ann Oncol 2012; 23: 1542-1549
4. Lindqvist O, Rasmussen BH, Widmark A,. Experiences of symptoms in men with hormone refractory prostate cancer and skeletal metastases. Eur J Oncol Nurs 2008; 12: 283-290
5. Kyrdalen AE, Dahl AA, Hernes E, Hem E, Fosså SD,. Fatigue in prostate cancer survivors treated with definitive radiotherapy and LHRH analogs. Prostate 2010; 70: 1480-1489
6. Monga U, Kerrigan AJ, Thornby J, et al. Prospective study of fatigue in localized prostate cancer patients undergoing radiotherapy. Radiat Oncol Investig 1999; 7: 178-185
7. Fletcher BS, Paul SM, Dodd MJ, et al. Prevalence, severity, and impact of symptoms on female family caregivers of patients at the initiation of radiation therapy for prostate cancer. J Clin Oncol 2008; 26: 599-605
8. Danjoux C, Gardner S, Fitch M,. Prospective evaluation of fatigue during a course of curative radiotherapy for localised prostate cancer. Support Care Cancer 2007; 15: 1169-1176
9. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351: 1502-1512
10. Alibhai SMH, Breunis H, Duff Canning S, et al. Fatigue in men starting androgen deprivation therapy (ADT) for non-metastatic prostate cancer. Proc 3rd Int Prostate Cancer Symp 2007; 3: 132
11. Culos-Reed S, Robinson JL, Lau H, et al. Benefits of a physical activity intervention for men with prostate cancer. J Sport Exerc Psychol 2007; 29: 118-127
12. Windsor P, Nicol KF, Potter J,. A randomized, controlled trial of aerobic exercise for treatment-related fatigue in men receiving radical external beam radiotherapy for localized prostate carcinoma. Cancer 2004; 101: 550-557
13. Gjerset GM, Fosså SD, Dahl AA, Loge JH, Ensby T, Thorsen L,. Effects of a 1-week inpatient course including information, physical activity, and group sessions for prostate cancer patients. J Cancer Educ 2011; 26: 754-760
14. Roth AJ, Nelson C, Rosenfeld B, et al. Methylphenidate for fatigue in ambulatory men with prostate cancer. Cancer 2010; 116: 5102-5110
15. Carroll JK, Kohli S, Mustian KM, Roscoe JA, Morrow GR,. Pharmacologic treatment of cancer-related fatigue. Oncologist 2007; 12: 43-51
16. Lower EE, Fleishman S, Cooper A, et al. Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial. J Pain Symptom Manage 2009; 38: 650-662
17. Minton O, Richardson A, Sharpe M, Hotopf M, Stone PC,. A systematic review and meta-analysis of the pharmacological treatment of cancer-related fatigue. J Natl Cancer Inst 2008; 100: 1155-1166
18. 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
19. Mar Fan HG, Clemons M, Xu W, et al. A randomised, placebo-controlled, double-blind trial of the effects of d-methylphenidate on fatigue and cognitive dysfunction in women undergoing adjuvant chemotherapy for breast cancer. Support Care Cancer 2008; 16: 577-583
20. Butler JM, Case LD, Atkins J, et al. A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo methylphenidate HCl in brain tumor patients receiving radiation therapy. Int J Radiat Oncol Biol Phys 2007; 69: 1496-1501
21. Moraska AR, Sood A, Dakhil SR, et al. Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial. J Clin Oncol 2010; 28: 3673-3679
22. Bruera E, Yennurajalingam S, Palmer JL, et al. Methylphenidate and/or a nursingtelephoneintervention for fatigue in patients with advanced cancer: a randomized, placebo-controlled, phase II trial. J Clin Oncol 2013; 31: 2421-2427
23. Breitbart W, Rosefeld B, Kaim M, Funesti-Esch J,. A randomized, double-blind, placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease. Arch Intern Med 2001; 161: 411-420
24. 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
25. Radloff LS,. The CES-D Scale: a self report depression scale for research in the general population. Appl Psychol Meas 1977; 1: 385-401
26. 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
27. Ware JE, Sherbourne CD,. The MOS 36-item short-form health survey (SF-36). Med Care 1992; 30: 473-483
28. Cella D,. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol 1997; 34: 13-19
29. Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE,. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 2002; 24: 547-561
30. Ware JE, Snow KK, Kosinski M, et al. SF-36 Health Survey: Manual & Interpretation Guide. Boston, MA: Nimrod Press, 1993
31. Gong S, Sheng P, Jin H, et al. Effect of methylphenidate in patients with cancer-related fatigue: a systematic review and meta-analysis. PLoS ONE 2014; 9: e84391
32. Godfrey J,. Safety of therapeutic methylphenidate in adults: a systematic review of the evidence. J Psychopharmacol 2009; 23: 194-205
33. Ross RG,. Psychotic and manic-like symptoms during stimulant treatment of attention deficit hyperactivity disorder. Am J Psychiatry 2006; 163: 1149-1152
34. American College of Physicians. Clinical guideline, part 2. Screening for thyroid diseases. Ann Intern Med 1998; 129: 144-158
35. Segal RJ, Reid RD, Courneya KS, et al. Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol 2003; 21: 1653-1659