Modafinil for the treatment of fatigue in lung cancer: Results of a placebo-controlled, double-blind, randomized trial

Journal of Clinical Oncology

Volumn 32, Issue 18, 2014, Pages 1882-1888

  Spathis, Anna ^a   Fife, Kate ^a   Blackhall, Fiona ^b   Dutton, Susan ^c   Bahadori, Ronja ^c   Wharton, Rose ^c   O'Brien, Mary ^e   Stone, Patrick ^f   Benepal, Tim ^g   Bates, Nick ^h   Wee, Bee ^c,d  

^a CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d Sir Michael Sobell House   (United Kingdom)

^e ROYAL MARSDEN HOSPITAL   (United Kingdom)

^f ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^g ST GEORGE'S UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^h BUCKINGHAMSHIRE HEALTHCARE NHS TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

METHYLPHENIDATE; MODAFINIL; PLACEBO; BENZHYDRYL DERIVATIVE; CENTRAL STIMULANT AGENT; WAKEFULNESS PROMOTING AGENT;

ADULT; ADVANCED CANCER; ARTICLE; CANCER CHEMOTHERAPY; CANCER FATIGUE; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SCREENING; CANCER STAGING; COMPARATIVE STUDY; CONTROLLED STUDY; DAYTIME SOMNOLENCE; DEPRESSION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; EPWORTH SLEEPINESS SCALE; FEMALE; FUNCTIONAL ASSESSMENT; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; LUNG CANCER; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PLACEBO EFFECT; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; AGED; CONTROLLED CLINICAL TRIAL; DRUG ADMINISTRATION; FATIGUE; LUNG TUMOR; MIDDLE AGED; MULTICENTER STUDY; SEVERITY OF ILLNESS INDEX; TREATMENT FAILURE; UNITED KINGDOM; VERY ELDERLY;

AGED; AGED, 80 AND OVER; BENZHYDRYL COMPOUNDS; CARCINOMA, NON-SMALL-CELL LUNG; CENTRAL NERVOUS SYSTEM STIMULANTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FATIGUE; FEMALE; GREAT BRITAIN; HUMANS; LUNG NEOPLASMS; MALE; METHYLPHENIDATE; MIDDLE AGED; PLACEBO EFFECT; SEVERITY OF ILLNESS INDEX; TREATMENT FAILURE; WAKEFULNESS-PROMOTING AGENTS;

EID: 84905374182     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2013.54.4346     Document Type: Article

References (31)

1. Hoffman M, Ryan J, Figueroa-Mosely CD, et al: Cancer-related fatigue: The scale of the problem. Oncologist 12:4-10, 2007 (suppl 1)
2. Forlenza M, Hall P, Lichtenstein P, et al: Epidemiology of cancer-related fatigue in the Swedish Twin Registry. Cancer 104:2022-2031, 2005 (Pubitemid 41513189)
3. 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 5:353-360, 2000
4. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology: Cancer-Related Fatigue (version 1), 2013
5. Estrada A, Kelley A, Webb C, et al: Modafinil as a replacement for dextroamphetamine for sustaining alertness in military helicopter pilots. Aviat Space Environ Med 83:556-564, 2012
6. Minzenberg M, Carter C: Modafinil: A review of neurochemical actions and effects on cognition. Neuropsychopharmacology 33:1477-1502, 2008 (Pubitemid 351684703)
7. Lange R, Volker M, Heesen C, et al: Modafinil effects in multiple sclerosis patients with fatigue. J Neurol 256:645-650, 2009
8. Rabkin J, Gordon P, McElhiney M, et al: Modafinil treatment of fatigue in patients with ALS: A placebo-controlled study. Muscle Nerve 39:297-303, 2009
9. Fava M, Thase ME, DeBattista C, et al: Modafinil augmentation of selective serotonin reuptake inhibitor therapy in MDD partial responders with persistent fatigue and sleepiness. Ann Clin Psychiatry 19:153-159, 2007 (Pubitemid 47345870)
10. Rabkin JG, McElhiney MC, Rabkin R, et al: Modafinil treatment for fatigue for HIV/AIDS: A placebo-controlled study. J Clin Psychiatry 71:707-715, 2010
11. Spathis A, Dhillan R, Booden D, et al: Modafinil for the treatment of fatigue in lung cancer: A pilot study. Palliat Med 23:325-331, 2009
12. Morrow GR, Gillies LJ, Hickok JT, et al: The positive effect of the psychostimulant modafinil on fatigue from cancer that persists after treatment is completed. J Clin Oncol 23:732s, 2005 (suppl; abstr 8012)
13. Blackhall L, Petroni G, Shu J, et al: A pilot study evaluating the safety and efficacy of modafinil for cancer-related fatigue. J Palliat Med 12:433-439, 2009
14. Jean-Pierre P, Morrow GR, Roscoe JA, et al: A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: A University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer 116:3513-3520, 2010
15. Brown S, Thorpe H, Hawkins K, et al: Minimization: Reducing predictability for multi-centre trials whilst retaining balance within centre. Stat Med 24:3715-3727, 2005 (Pubitemid 43115727)
16. Yellen SB, Cella DF, Webster K, et al: Measuring fatigue and other anaemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 13:63-74, 1997 (Pubitemid 27147321)
17. Cella D, Eton DT, Lai JS, et al: Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue subscales. J Pain Symptom Manage 24:574-561, 2002
18. Johns MW: A new method for measuring daytime sleepiness: The Epworth Sleepiness Scale. Sleep 14:540-545, 1991
19. Zigmond AS, Snaith RP: The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 67:361-370, 1983 (Pubitemid 13098606)
20. HuschkaMM,Mandrekar SJ, Schaefer PL, et al: A pooled analysis of quality of life measures and adverse events data in North Central Cancer Treatment Group lung cancer clinical trials. Cancer 109:787-795, 2007 (Pubitemid 46233242)
21. Stankoff B, Waubant E, Confavreux C, et al: Modafinil for fatigue in MS: A randomized placebo-controlled double-blind study. Neurology 64:1139-1143, 2005
22. Möller F, Poettgen J, Broemel F, et al: HAGIL (Hamburg Vigil Study): A randomized placebo-controlled double-blind study with modafinil for the treatment of fatigue in patients with multiple sclerosis. Mult Scler 17:1002-1009, 2011
23. Chan KM, Strohschein FJ, Rydz D, et al: Randomized controlled trial of modafinil for the treatment of fatigue in postpolio patients. Muscle Nerve 33:138-141, 2006 (Pubitemid 43062997)
24. Vasconcelos OM, Prokhorenko OA, Salajegheh MK, et al: Modafinil for treatment of fatigue post-polio syndrome: A randomised controlled trial. Neurology 68:1680-1686, 2007 (Pubitemid 46763255)
25. Jha A, Weintraub A, Allshouse A, et al: A randomised trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury. J Head Trauma Rehab 23:52-63, 2008 (Pubitemid 351161171)
26. Bruera E, Valero V, Driver L, et al: Patient-controlled methylphenidate for cancer fatigue: A double-blind, randomized, placebo-controlled trial. J Clin Oncol 24:2073-2078, 2006 (Pubitemid 46622117)
27. 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 16:577-583, 2008
28. Roth A, Nelson C, Rosenfeld B, et al: Methylphenidate for fatigue in ambulatory men with prostate cancer Cancer 116:5102-5110, 2010
29. Goligher EC, Pouchot J, Brant R, et al: Minimal clinically important difference for 7 measures of fatigue in patients with systemic lupus erythematosis. J Rheumatol 35:635-642, 2008 (Pubitemid 351500059)
30. Pouchot J, Kherani RB, Brant R, et al: Determination of the minimal clinically important difference for seven fatigue measures in rheumatoid arthritis. J Clin Epidemiol 61:705-713, 2008
31. Minton O, Richardson A, Sharpe M, et al: Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev 7:CD006704, 2010