Modafinil for attentional and psychomotor dysfunction in advanced cancer: A double-blind, randomised, cross-over trial

Palliative Medicine

Volumn 23, Issue 8, 2009, Pages 731-738

  Lundorff, L E ^a   Jonsson B H ^a   Sjogren P ^b  

^a HERNING HOSPITAL   (Denmark)

^b Rigshospitalet   (Denmark)

Author keywords

Cancer; Cognition; Modafinil; Neuropsychological assessment and symptoms

Indexed keywords

AMITRIPTYLINE; CITALOPRAM; FENTANYL; METHADONE; METHYLPREDNISOLONE; MODAFINIL; MORPHINE; NARCOTIC ANALGESIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; NORTRIPTYLINE; OXAZEPAM; OXYCODONE; PARACETAMOL; PLACEBO; PREGABALIN; SEROTONIN UPTAKE INHIBITOR; ZOPICLONE;

ADULT; ADVANCED CANCER; AGED; ANXIETY; ARTICLE; ATTENTION DISTURBANCE; BREAST CANCER; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEPRESSION; DIARRHEA; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG INDUCED HEADACHE; EDMONTON SYMPTOM ASSESSMENT SYSTEM; FATIGUE; FEMALE; HANDEDNESS; HEAD AND NECK CANCER; HEMATOLOGIC MALIGNANCY; HUMAN; KARNOFSKY PERFORMANCE STATUS; LUNG CANCER; MALE; NAUSEA; NEUROPSYCHOLOGICAL TEST; PAIN; PSYCHOMOTOR DISORDER; PSYCHOMOTOR PERFORMANCE; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; SCORING SYSTEM; SIDE EFFECT; SINGLE DRUG DOSE; SLEEP DISORDER; UNSPECIFIED SIDE EFFECT; UROGENITAL TRACT CANCER; VIVID DREAM;

ADULT; AGED; ATTENTION; BENZHYDRYL COMPOUNDS; CENTRAL NERVOUS SYSTEM STIMULANTS; COGNITION DISORDERS; CROSS-OVER STUDIES; FATIGUE; FEMALE; HUMANS; KARNOFSKY PERFORMANCE STATUS; MALE; MIDDLE AGED; NEOPLASMS; NEUROPSYCHOLOGICAL TESTS; PSYCHOMOTOR PERFORMANCE; SLEEP;

EID: 74849106904     PISSN: 02692163     EISSN: None     Source Type: Journal    
DOI: 10.1177/0269216309106872     Document Type: Article

References (56)

1. Pereira J., Hanson J., Bruera E. The frequency and clinical course of cognitive impairment in patients with terminal cancer. Cancer 1997 ; 97: 835-842.
2. Lawlor PG, Gagnon B., Mancini IL, Pereira JL, Hanson J., Suarez-Almazor ME, et al. Occurrence, causes, and outcome of delirium in advanced cancer patients: a prospective study. Arch Int Med 2000 ; 160: 786-794.
3. Homsi J., Walsh D., Rivera N., Rybicki LA, Nelson KA, Legrand SB, et al. Symptom evaluation in palliative medicine: patient report vs systematic assessment. Support Cancer Care 2006 ; 14: 444-453.
4. Wong YN, King SP, Watson BL, Simcoe D., Laughton W., McCormick GC, et al. Open-label, single-dose pharmacokinetic study of modafinil tablets: influence of age and gender in normal subjects. J Clin Pharmacol 1999 ; 39: 281-288.
5. Cox JM, Pappagallo M. Modafinil: a gift to portmanteau. Am J Hosp Palliat Care 2001 ; 18: 408-410.
6. Lin J. -S, Hou Y., Jouvet M. Potential brain neural targets for amphetamine-, methylphenidate-, and modafinil-induced wakefulness, evidenced by c-fos immunochemistry in the cat. Proc Natl Acad Sci U S A 1996 ; 93: 14128-14133.
7. Ferrano L., Antonelli T., O?Conner WT, Tanganelli S., Rambert FA, Fuxe K. Moddafinil: an antinarcoleptic drug with a different neurochemical profile to amphetamine dopamine uptake blockers. Biol Psychiatry 1997 ; 42: 1181-1183.
8. Engber TM, Dennis SA, Jones MS, Miller MS, Contreras PC Brain regional substrates for the actions of the novel wake-promoting agent modafinil in the rat: comparison with amphetamine. Neuroscience 1998 ; 87: 905-911.
9. Rammohan KW, Rosenberg JH, Lynn DJ, Blumenfeld AM, Nagaraja HN Efficacy and safety of modafinil (ProvigilR) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study. J Neurol Neurosurg Psychiatry 2002 ; 72: 179-183.
10. Pachas WN Modafinil for the treatmenrt of fatigue of fibromyalgia. J Clin Rheumatol 2003 ; 9: 140-146.
11. Webster L., Andrews M., Stoddard G. Modafinil treatment of opioid-induced sedation. Pain Med 2003 ; 4: 135-140.
12. Harsh JR, Hayduk R., Rosenberg R., Wesnes KA, Walsh JK, Arora S., et al. The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated wih narcolepsy. Curr Med Res Opin 2006 ; 22: 761-774.
13. Turner DC, Clark L., Pomarol-Clotet E., McKenna P., Robbins TW, Sahakian BJ Modafinil improves cignition and attentional set shifting in patients with chronic schizophrenia. Neuropsychopharmacol 2004 ; 29: 1363-1373.
14. DeBattista C., Lembke A., Solvason HB, Ghebremichael R., Poirier J. A prospective trial of modafinil as an adjunctive treatment of major depression. J Clin Psychopharmacol 2004 ; 24: 7-90.
15. Morrow GR, Gillies LJ, Hickok JT, Roscoe JA, Padmanaban D., Griggs JJ The positive effect of the psychostimulant modafinil on fatigue from cancer that persists after treatment is completed. 41st ASCO Annual Meeting, May 13-17 2005, Orlando, FL, USA. J Clin Oncol 2005 ; 23(Suppl.): 8012.
16. Kaleita TA, Wellisch DK, Graham CA, Steh B., Nghiemphu P., Ford JM, et al. Pilot study of modafinil for treatment of neurobehavioral dysfunction and fatigue in adult patients with brain tumors. 42th ASCO Annual Meeting. June 2-6, 2006. Atlanta, Georgia, USA. J. Clin. Oncol 2006 ; 24(Suppl.): 1503.
17. Peters M. Prolonged practice of a simple motor task by preferred and non-preferred hands. Percept Mot Skills 1976 ; 42: 447-450.
18. Morrison MW, Gregory RJ, Paul JJ Reliability of the finger tapping test and a note of sex differences. Percept Mot Skills 1979 ; 48: 139-142.
19. Roth N., Battig K. Effects of cigarette smoking upon frequencies of EEG alpha rhythm and finger tapping. Psychopharmacology 1991 ; 205: 186-190.
20. Duchet JM, Balota DA, Ferraro FR Component analysis of a rhythmic finger tapping task in individuals with senile dementia of the Alzheimer type and in individuals with Parkinson?s disease. Neuropsychology 1994 ; 8: 218-226.
21. Boecker H., Kleinschmidt A., Requardt M., Hanicke W., Merboldt KD, Frahm J. Functional cooperativity of human cortical areas during self-paced simple finger movements; a high-solution MRI study. Brain 1994 ; 117: 1231-1239.
22. Bornstein RA Normative data on selected neuropsychological measures from a non-clinical sample. J Clin Psychol 1985 ; 41: 480-482.
23. Sjøgren P., Olsen AK, Thomsen AB, Dalberg J. Neuropsychological performance in cancer patients: the role of opioids, pain and performance status. Pain 2000 ; 86: 237-245. (Pubitemid 30254264)
24. Davies ADM. The influence of age on trail making test performance. J Clin Psychol 1968 ; 24: 96-98.
25. Horton AM Some suggestions regarding the clinical interpretation of the Trial Making Test. Clin Neuropsychol 1979 ; 1: 20-23.
26. Lezak MD Neuropsychological assessment, 3 rd edn. New York: Oxford University Press, 1995.
27. Jensen ML, Sjøgren P., Upton RN, Foster DJR, Bonde P., Graae C., et al. Pharmacokinetic-pharmacodynamic relationships of cognitive and psychomotor effects of intravenous buprenorphine infusion in human volunteers. Basic Clin Pharmacol Toxicol 2008 ; 103: 94-101.
28. Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer 2000 ; 88: 2164-2171.
29. Yates JW, Chalmer B., McKegney TP Evaluation of patients with advanced cancer using the Karnofsky performance status. Cancer 1989 ; 45: 2220-2224.
30. Orr ST, Aisner J. Performance status among oncology patients: a review. Cancer Treat Rev 1986 ; 70: 1423-1429.
31. Karnofsky DA, Abelman WH, Craver LF, Burchenal JH The use of the nitrogen mustards in palliative treatment of carcinoma. Cancer 1948 ; 1: 634-656.
32. Bruera E., Chadwick S., Brenneis C., Hanson J., MacDonald RN Methylphenidate associated with narcotics for the treatment of cancer pain. Cancer Treat Rep 1987 ; 71: 67-70. (Pubitemid 17003435)
33. SAS Institute Inc. SAS/STAT 9.1 User?s Guide. Vol. 1-7, Cary, NC, USA: SAS Institute Inc, 2004.
34. Bruera E., Miller MJ, Macmillan K., Kuehn N. Neuropsychological effects of methylphenidate in patients receiving a continuous infusion of narcotics for cancer pain. Pain 1992 ; 48: 163-166.
35. Bruera E., Valero V., Driver L., Shen L., Willey J., Zhang T., et al. Patient-controlled methylphenidate for cancer fatigue: a double-blind, randomized, placebo-controlled trial. J Clin Oncol 2006 ; 24: 2073-2078.
36. Nasr S., Wendt B., Steiner K. Absence of mood switch with and tolerance to modafinil: a replication study from a large private practice. J Affect Disord 2006 ; 95: 111-114.
37. Castellon SA, Ganz PA, Bower JE, ?...petersen L., Abraham L., Greendale GA Neurocognitive performance in breast cancer survivors exposed to adjuvant chemotherapy and tamoxifen. J Clin Neuropsychol 2004 ; 26: 955-969.
38. Derogatis LR, Morrow GR, Fetting J., Penman D., Piasetsky S., Schmale AM, et al. The prevalence of psychiatric disorders among cancer patients. JAMA 1983 ; 249: 751-757.
39. Ventafridda V., Ripamonti C., DeConno F., Tamburini M., Cassileth BR, et al. Symptom prevalence and control during cancer patients last days of life. J Palliat Care 1990 ; 6: 7-11.
40. Stufel FC, Holland JC Delirium in cancer patients. Int Psychogeriatry 1991 ; 3: 333-336.
41. Strmgren AS, Goldschimdt D., Groenvold M., Petersen MA, Jensen PT, Pedersen L., et al. Self-assessment in cancer patients referred to palliative care: a study of feasibility and symptom epidemiology. Cancer 2002 ; 94: 412-520.
42. Levine PM, Silberfarb PM, Lipowski ZJ Mental disorders in cancer patients: a study of 100 psychiatric referrals. Cancer 1978 ; 43: 1385-1391.
43. Massie MJ, Holland J., Glass E. Delirium in terminally ill cancer patients. Am J Psychiat 1983 ; 140: 1848-1850.
44. Sjøgren P. Psychomotor and cognitive functioning in cancer patients. Acta Anaesth Scand 1997 ; 41: 159-161.
45. Bruera E., Macmillan K., Hanson J., MacDonald RN The cognitive effects of the administration and narcotic analgesics in patients with cancer pain. Pain 1989 ; 39: 13-16. (Pubitemid 19258904)
46. Vainio A., Ollila J., Matikainen E., Rosenberg P., Kaiso E. Driving ability in cancer patients receiving long-term morphine analgesia. Lancet 1995 ; 346: 667-670.
47. Kamboj SV, Tookman A., Jones L., Curran HV The effects of immediate-release morphine on cognitive functioning in patients receiving chronic opioid therapy in palliative care. Pain 2005 ; 117: 388-395.
48. Klepstad P., Hilton P. Moen, Fougner B, Borchgrevink PC, Kaasa S. Self-reports are not related to objective assessment of cognitive function and sedation in patients with cancer pain admitted to a palliative care unit. Palliat Med 2002 ; 16: 513-519.
49. Barsevick AM, Whitmer K., Nail L., Beck SL, Dudley WN Symptom cluster research: conceptual, design, measurement, and analysis issue. J Pain Symptom Manage 2006 ; 31: 85-95.
50. Macleod AD Methylphenidate in terminal depression. J Pain Symptom Manage 1998 ; 16: 193-198.
51. Homsi J., Nelson KA, Sarhill N., Rybicki L., LeGrand SB, Davis MP, et al. A phase II study of methylphenidate for depression in advanced cancer. Am J Hosp Palliat Care 2001 ; 18: 403-407.
52. Lundt L. Modafinil treatment in patients with seasonal affective disorder/winter depression: an open label pilot study. J Affect Disord 2004 ; 81: 173-178.
53. Vaishnavi S., Gadde K., Alamy S., Zhang W., Connor K., Davidson JR Modafinil for atypical depression: effects of open
54. Randall DC, Shneerson JM, Plaha KK, File SE Modafinil affects mood, but not cognitive function, in healthy young volunteers. Hum Psychopharmacol 2003 ; 18: 163-173.
55. Zifko UA, Rupp M., Schwarz S., Zipko HT, Maida EM Modafinil in treatment of fatigue in multiplr sclerosis. Results of an open-label study. J Neurol 2002 ; 249: 983-987.
56. Hart CL, Haney M., Vosburg SK, Comer SD, Gunderson E., Foltin RW Modafinil attenuates disruptions in cognitive performance during simulated night-shift work. Neuropsychopharmacol 2006 ; 31: 1526-1536.