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.
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.
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DOI：
10.1002/cncr.25083
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发表时间：
2010-07-15
期刊：
影响因子：
6.2
通讯作者：
Hopkins, Judith O.
中科院分区：
文献类型：
--
作者：
Jean-Pierre, Pascal;Morrow, Gary R.;Roscoe, Joseph A.;Heckler, Charles;Mohile, Supriya;Janelsins, Michelle;Peppone, Luke;Hemstad, Amy;Esparaz, Benjamin T.;Hopkins, Judith O.
关键词：
癌症相关性疲劳（CRF）是一种使人衰弱的症状，影响70%至100%的癌症患者在治疗期间和治疗后的心理社会功能和生活质量。我们研究了每日200 mg莫达非尼对CRF严重程度的影响。我们进行了一项多中心、随机、双盲、安慰剂对照的III期临床试验，以检查莫达非尼对接受化疗的癌症患者的患者报告疲劳的影响。在23个地理上独立的URCC CCOP附属机构开始化疗的877名癌症患者的样本进行了疲劳评估。报告疲劳的患者（N=867）被随机分配接受每日200 mg口服莫达非尼（PROVIGIL®）或安慰剂。治疗从第2周期第5天开始，在第4周期第7天后结束。在周期2至4期间，使用心理测量学有效指标评估疲劳和抑郁。使用协方差分析（ANCOVA）对基线疲乏（周期2）进行调整，检查周期4前一周内最差疲乏水平的组间差异（治疗组与对照组）。631例患者（莫达非尼组315例，安慰剂组316例）提供了可评价数据。ANCOVA显示治疗条件和基线疲劳之间存在显着的相互作用（p = 0.017），其中重度基线疲劳的患者（n=458）从莫达非尼中受益，而轻度或中度疲劳的患者则没有。莫达非尼对抑郁症的疗效无统计学意义（p > 0.05）。莫达非尼可能有助于控制严重疲劳患者的CRF，但对轻度或中度疲劳患者无效。
Cancer-related fatigue (CRF) is a debilitating symptom affecting psychosocial functioning and quality of life in 70 to 100% of cancer patients during and following treatment. We examined the effect of 200 mg of modafinil daily on the severity of CRF. We conducted a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to examine the effect of modafinil on patient-reported fatigue in cancer patients undergoing chemotherapy. A sample of 877 cancer patients beginning chemotherapy at 23 geographically separate URCC CCOP affiliates were assessed for fatigue. Patients who reported fatigue (N=867) were randomly assigned to receive either 200 mg of oral modafinil (PROVIGIL®) daily or a placebo. Treatment began on Day 5 of Cycle 2 and ended after Day 7 of Cycle 4. Fatigue and depression were assessed during Cycles 2 to 4 using psychometrically valid measures. Group differences (treatment versus control) in the worst level of fatigue during the previous week at Cycle 4 were examined using an analysis of covariance (ANCOVA) adjusting for baseline fatigue (Cycle 2). 631 patients (315 modafinil, 316 placebo) provided evaluable data. ANCOVA showed a significant interaction between treatment condition and baseline fatigue (p = 0.017), where patients with severe baseline fatigue (n=458) benefited from modafinil while patients with mild or moderate fatigue did not. Modafinil had no statistically significant effect on depression (p > 0.05). Modafinil may be useful in controlling CRF in patients presenting with severe fatigue but not in patients with mild or moderate fatigue.
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影响因子：
45.3
作者：
Morrow, GR;Hickok, JT;King, DK
通讯作者：
King, DK
影响因子：
5.8
作者：
Jean-Pierre, Pascal;Figueroa-Moseley, Colmar D.;Morrow, Gary R.
通讯作者：
Morrow, Gary R.
影响因子：
3.1
作者：
Curran, SL;Beacham, AO;Andrykowski, MA
通讯作者：
Andrykowski, MA
影响因子：
3.8
作者：
Roscoe, JA;Morrow, GR;Smith, B
通讯作者：
Smith, B
DOI：
10.1046/j.1523-5394.1999.75008.x
发表时间：
1999-09-01
期刊：
CANCER PRACTICE
影响因子：
--
作者：
Gaston-Johansson, F;Fall-Dickson, JM;Kennedy, MJ
通讯作者：
Kennedy, MJ