Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial.
PURPOSE: Fatigue is a distressing symptom occurring in more than 60% of patients with cancer. The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue, despite a limited evidence base. We aimed to evaluate the efficacy and tolerability of modafinil...
| Main Authors: | , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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American Society of Clinical Oncology
2014
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| _version_ | 1797064723968032768 |
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| author | Spathis, A Fife, K Blackhall, F Dutton, S Bahadori, R Wharton, R O'Brien, M Stone, P Benepal, T Bates, N Wee, B |
| author_facet | Spathis, A Fife, K Blackhall, F Dutton, S Bahadori, R Wharton, R O'Brien, M Stone, P Benepal, T Bates, N Wee, B |
| author_sort | Spathis, A |
| collection | OXFORD |
| description | PURPOSE: Fatigue is a distressing symptom occurring in more than 60% of patients with cancer. The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue, despite a limited evidence base. We aimed to evaluate the efficacy and tolerability of modafinil in the management of fatigue in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Adults with advanced NSCLC and performance status of 0 to 2, who were not treated with chemotherapy or radiotherapy within the last 4 weeks, were randomly assigned to daily modafinil (100 mg on days 1 to 14; 200 mg on days 15 to 28) or matched placebo. The primary outcome was change in Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue score from baseline to 28 days, adjusted for baseline fatigue and performance status. Secondary outcomes included safety and patient-reported measures of depression, daytime sleepiness, and quality of life. RESULTS: A total of 208 patients were randomly assigned, and 160 patients (modafinil, n = 75; placebo, n = 85) completed questionnaires at both baseline and day 28 and were included in the modified intention-to-treat analysis. FACIT-Fatigue scores improved from baseline to day 28 (mean score change: modafinil, 5.29; 95% CI, 2.57 to 8.02; placebo, 5.09; 95% CI, 2.54 to 7.65), but there was no difference between treatments (0.20; 95% CI, -3.56 to 3.97). There was also no difference between treatments for the secondary outcomes; 47% of the modafinil group and 23% of the placebo group stated that the intervention was not helpful. CONCLUSION: Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting. Its use was associated with a clinically significant placebo effect. |
| first_indexed | 2024-03-06T21:18:25Z |
| format | Journal article |
| id | oxford-uuid:4098155e-1f2b-4a9e-8ea8-8315d6f87df8 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T21:18:25Z |
| publishDate | 2014 |
| publisher | American Society of Clinical Oncology |
| record_format | dspace |
| spelling | oxford-uuid:4098155e-1f2b-4a9e-8ea8-8315d6f87df82022-03-26T14:38:51ZModafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:4098155e-1f2b-4a9e-8ea8-8315d6f87df8EnglishSymplectic Elements at OxfordAmerican Society of Clinical Oncology2014Spathis, AFife, KBlackhall, FDutton, SBahadori, RWharton, RO'Brien, MStone, PBenepal, TBates, NWee, BPURPOSE: Fatigue is a distressing symptom occurring in more than 60% of patients with cancer. The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue, despite a limited evidence base. We aimed to evaluate the efficacy and tolerability of modafinil in the management of fatigue in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Adults with advanced NSCLC and performance status of 0 to 2, who were not treated with chemotherapy or radiotherapy within the last 4 weeks, were randomly assigned to daily modafinil (100 mg on days 1 to 14; 200 mg on days 15 to 28) or matched placebo. The primary outcome was change in Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue score from baseline to 28 days, adjusted for baseline fatigue and performance status. Secondary outcomes included safety and patient-reported measures of depression, daytime sleepiness, and quality of life. RESULTS: A total of 208 patients were randomly assigned, and 160 patients (modafinil, n = 75; placebo, n = 85) completed questionnaires at both baseline and day 28 and were included in the modified intention-to-treat analysis. FACIT-Fatigue scores improved from baseline to day 28 (mean score change: modafinil, 5.29; 95% CI, 2.57 to 8.02; placebo, 5.09; 95% CI, 2.54 to 7.65), but there was no difference between treatments (0.20; 95% CI, -3.56 to 3.97). There was also no difference between treatments for the secondary outcomes; 47% of the modafinil group and 23% of the placebo group stated that the intervention was not helpful. CONCLUSION: Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting. Its use was associated with a clinically significant placebo effect. |
| spellingShingle | Spathis, A Fife, K Blackhall, F Dutton, S Bahadori, R Wharton, R O'Brien, M Stone, P Benepal, T Bates, N Wee, B Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. |
| title | Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. |
| title_full | Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. |
| title_fullStr | Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. |
| title_full_unstemmed | Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. |
| title_short | Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. |
| title_sort | modafinil for the treatment of fatigue in lung cancer results of a placebo controlled double blind randomized trial |
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