SCI

17 June 2024

Methylphenidate Versus Placebo for Treating Fatigue in Patients With Advanced Cancer: Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

（Journal of clinical oncology ；IF：45.3）

  • Stone PC, Minton O, Richardson A, Buckle P, Enayat ZE, Marston L, Freemantle N. Methylphenidate Versus Placebo for Treating Fatigue in Patients With Advanced Cancer: Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial. J Clin Oncol. 2024 May 17:JCO2302639. doi: 10.1200/JCO.23.02639. Epub ahead of print. PMID: 38757263.

  • CORRESPONDING AUTHOR ：Patrick Charles Stone, MD, MA, MRCP; e-mail: p.stone@ucl.ac.uk.

    Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London (UCL), London, United Kingdom

Purpose 目的

To compare effects and side effects of 6 weeks of individually dose-titrated methylphenidate or placebo on fatigue in palliative care patients with advanced cancer.

比较6周个体剂量调节的哌甲酯或安慰剂对姑息性治疗晚期癌症患者疲劳的影响和副作用。

 

Methods 方法

This is a randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients had advanced incurable cancer and fatigue >3/10. Principal exclusions were hypertension; psychiatric, cardiovascular, cerebrovascular, renal, liver, or blood disorders; substance dependency; and epilepsy. Patients were randomly assigned 1:1 methylphenidate or placebo starting at 5 mg twice daily. Dose of methylphenidate/placebo was titrated once per week, over 6 weeks, up to a maximum of 20 mg three times daily. Trial ended at 10 weeks. Primary outcome was the difference in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores between groups at 6 ± 2 weeks. Secondary outcomes included adverse effects, quality of life, and mood.

这是一项随机、双盲、安慰剂对照、多中心试验。符合条件的患者患有晚期不可治愈的癌症且疲劳评分大于3/10。主要排除标准包括高血压、精神疾病、心血管疾病、脑血管疾病、肾脏、肝脏或血液疾病、物质依赖和癫痫。患者被随机分配到哌甲酯或安慰剂组，比例为1:1，起始剂量为每天两次，每次5毫克。哌甲酯/安慰剂的剂量每周调节一次，持续6周，最大剂量为每天三次，每次20毫克。试验在10周时结束。主要结果是组间在6 ± 2周时慢性病治疗相关性疲乏功能评估量表（FACIT-F）评分的差异。次要结果包括不良反应、生活质量和情绪。

 

Results 结果

One hundred sixty-two patients (73 men; mean, 65.8; standard deviation [SD], 10.3 years) were randomly assigned, and three were excluded from analysis. Seventy-seven were allocated placebo (baseline FACIT-F = 22 [SD, 10]); 82 were allocated methylphenidate (FACIT-F = 20 [SD, 9]). After 6 ± 2 weeks, FACIT-F scores were 1.97 points (95% CI, -0.95 to 4.90; P = .186) higher (better) on methylphenidate than placebo. Across 10 weeks of the study, FACIT-F was nominally higher in the methylphenidate group versus placebo (Diff, 2.20 [95% CI, 0.39 to 4.01]), but this did not reach the minimally clinically important difference (5-points). At 6 weeks, there were no differences between groups in quality-of-life or symptom domains except for depression scores (nominally reduced in the methylphenidate group: Diff, -1.35 [95% CI, -2.41 to -0.30]). There were no differences in mortality or serious adverse events.

162名患者（73名男性；平均年龄65.8岁；标准差[SD] 10.3岁）被随机分配，3名患者被排除在分析之外。77名患者分配到安慰剂组（基线FACIT-F=22 [SD, 10]）；82名患者分配到哌甲酯组（FACIT-F=20 [SD, 9]）。经过6±2周后，哌甲酯组的FACIT-F评分比安慰剂组高1.97分（95% CI，-0.95至4.90；P=0.186）。在整个10周的研究期间，哌甲酯组的FACIT-F评分名义上高于安慰剂组（差异，2.20 [95% CI，0.39至4.01]），但未达到临床上重要的差异（5分）。在6周时，除了抑郁评分在哌甲酯组名义上降低（差异，-1.35 [95% CI，-2.41至-0.30]）外，两组在生活质量或症状领域没有差异。两组在死亡率或严重不良事件方面没有差异。

 

Conclusion 结论

After 6 ± 2 weeks of treatment, methylphenidate was not superior to placebo for treating fatigue in advanced cancer. Methylphenidate was safe and well-tolerated.

经过6 ± 2周的治疗，哌甲酯在治疗晚期癌症疲劳方面并不优于安慰剂。哌甲酯是安全且耐受性良好的。