دورية أكاديمية
The Effect of Methylphenidate on Fatigue in Advanced Cancer: An Aggregated N-of-1 Trial.
| العنوان: | The Effect of Methylphenidate on Fatigue in Advanced Cancer: An Aggregated N-of-1 Trial. |
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| المؤلفون: | Mitchell GK; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: g.mitchell@uq.edu.au., Hardy JR; Department of Palliative and Supportive Care, Mater Health Services, South Brisbane, Queensland, Australia; Mater Research, University of Queensland, South Brisbane, Queensland, Australia., Nikles CJ; School of Medicine, University of Queensland, Brisbane, Queensland, Australia., Carmont SA; School of Medicine, University of Queensland, Brisbane, Queensland, Australia., Senior HE; School of Medicine, University of Queensland, Brisbane, Queensland, Australia., Schluter PJ; School of Health Sciences, University of Canterbury, Christchurch, New Zealand., Good P; Department of Palliative and Supportive Care, Mater Health Services, South Brisbane, Queensland, Australia; Mater Research, University of Queensland, South Brisbane, Queensland, Australia; St. Vincent's Private Hospital, Brisbane, Queensland, Australia., Currow DC; Cancer Institute of New South Wales, Sydney, New South Wales, Australia; Department of Palliative and Supportive Care, Flinders University, Adelaide, South Australia, Australia. |
| المصدر: | Journal of pain and symptom management [J Pain Symptom Manage] 2015 Sep; Vol. 50 (3), pp. 289-96. Date of Electronic Publication: 2015 Apr 18. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 8605836 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-6513 (Electronic) Linking ISSN: 08853924 NLM ISO Abbreviation: J Pain Symptom Manage Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York, NY : Elsevier Original Publication: [Madison, WI : Dept. of Anesthesiology, University of Wisconsin--Madison, 1986- |
| مواضيع طبية MeSH: | Central Nervous System Stimulants/*therapeutic use , Fatigue/*drug therapy , Fatigue/*physiopathology , Methylphenidate/*therapeutic use , Neoplasms/*physiopathology , Palliative Care/*methods, Adult ; Aged ; Aged, 80 and over ; Australia ; Central Nervous System Stimulants/adverse effects ; Cross-Over Studies ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Male ; Methylphenidate/adverse effects ; Middle Aged ; Neoplasms/drug therapy ; Severity of Illness Index ; Terminal Care/methods ; Treatment Outcome |
| مستخلص: | Context: Fatigue is common in life-limiting cancer. Methylphenidate (MPH), a psychostimulant, may be a useful therapy. Gathering evidence in patients with advanced cancer can be challenging. Objectives: To determine if MPH improves cancer-related fatigue in people with advanced cancer. Methods: N-of-1 trials are multicycle, double-blind, randomized, controlled crossover trials using standardized measures of effect in individuals. They are normally used to assess treatment effects in individuals. Aggregated N-of-1 trials from participants with end-stage cancer suffering fatigue were used to assess the group effect of MPH, producing an estimate of equivalent power to a parallel-group randomized controlled trial (RCT) but requiring less than half of the sample size. Up to three cycles of MPH 5 mg twice daily (three days) vs. identical placebo (three days) capsules were offered to participants. Primary outcome was improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale and the Wu Cancer Fatigue Scale. Analysis used Bayesian statistical methods using intention-to-treat principles. Results: Forty-three participants completed 84 cycles of MPH and placebo in random order, exceeding sample size estimates. Overall, MPH did not improve fatigue (mean difference 3.2; 95% credible interval -2.0, 9.0; posterior probability of favorable effect 0.890). Eight participants showed important improvement, and one participant showed important worsening of fatigue on MPH. There were no features that distinguished participants whose fatigue responded to MPH compared with those who did not. Conclusion: MPH does not improve fatigue in the population of patients with end-stage cancer. Aggregated N-of-1 trial methodology is feasible and produces population-based sample estimates with less than half the sample size required for the equivalent parallel-group RCT. It also identified individuals who did and did not respond to MPH, which is a feature difficult to achieve in a standard RCT. The study was registered with the Australian Clinical Trials Registry (12609000794202). (Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.) |
| التعليقات: | Comment in: J Pain Symptom Manage. 2015 Sep;50(3):287. (PMID: 26254017) |
| فهرسة مساهمة: | Keywords: Methylphenidate; N-of-1 trial; advanced cancer; fatigue; palliative care |
| المشرفين على المادة: | 0 (Central Nervous System Stimulants) 207ZZ9QZ49 (Methylphenidate) |
| تواريخ الأحداث: | Date Created: 20150422 Date Completed: 20161114 Latest Revision: 20220409 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.jpainsymman.2015.03.009 |
| PMID: | 25896104 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1873-6513 |
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| DOI: | 10.1016/j.jpainsymman.2015.03.009 |