Palliative Care, Rehabilitation, and Integrative Medicine
Genitourinary Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
J Natl Compr Canc Netw. 2017 Sep;15(9):1111-1120. doi: 10.6004/jnccn.2017.0149.
Despite the high frequency, severity, and effects of cancer-related fatigue (CRF) on the quality of life (QoL) of patients with cancer, limited treatment options are available. The primary objective of this study was to compare the effects of oral extract (PG) and placebo on CRF. Secondary objectives were to determine the effects of PG on QoL, mood, and function. In this randomized, double-blind, placebo-controlled study, patients with CRF ≥4/10 on the Edmonton Symptom Assessment System (ESAS) were eligible. Based on a pilot study, we randomized patients to receive either 400 mg of standardized PG twice daily or a matching placebo for 28 days. The primary end point was change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale from baseline to day 29. Of 127 patients, 112 (88.2%) were evaluable. The mean (SD) FACIT-F subscale scores at baseline, day 15, and day 29 were 22.4 (10.1), 29.9 (10.6), and 30.1 (11.6) for PG (<.001), and 24.0 (9.4), 30.0 (10.1), and 30.4 (11.5) for placebo (<.001). Mean (SD) improvement in the FACIT-F subscale at day 29 was not significantly different in the PG than in the placebo group (7.5 [12.7] vs 6.5 [9.9]; =.67). QoL, anxiety, depression, symptoms, and functional scores were not significantly different between the PG and placebo groups. Improvement in the FACIT-F subscale correlated with baseline scores (=.0005), Hospital Anxiety and Depression Scale results (=.032), and sex (=.023). There were fewer any-grade toxicities in the PG versus placebo group (28/63 vs 33/64; =.024). Both PG and placebo result in significant improvement in CRF. PG was not significantly superior to placebo after 4 weeks of treatment. There is no justification to recommend the use of PG for CRF. Further studies are needed. ClinicalTrials.gov identifier: NCT01375114.
尽管癌症相关性疲劳 (CRF) 在癌症患者的生活质量 (QoL) 方面出现的频率高、程度严重且影响大，但可用的治疗选择有限。本研究的主要目的是比较口服提取物 (PG) 和安慰剂对 CRF 的影响。次要目标是确定 PG 对 QoL、情绪和功能的影响。 在这项随机、双盲、安慰剂对照研究中，符合以下条件的患者被纳入： Edmonton 症状评估系统 (ESAS) 上的 CRF≥4/10。根据一项初步研究，我们将患者随机分为每天两次接受 400 毫克标准化 PG 或匹配安慰剂，共 28 天。主要终点是从基线到第 29 天功能性评估慢性疾病治疗疲劳量表 (FACIT-F) 子量表的变化。 在 127 名患者中，112 名（88.2%）可评估。PG 组基线、第 15 天和第 29 天的 FACIT-F 子量表评分分别为 22.4（10.1）、29.9（10.6）和 30.1（11.6）（<.001），安慰剂组分别为 24.0（9.4）、30.0（10.1）和 30.4（11.5）（<.001）。PG 组和安慰剂组在第 29 天的 FACIT-F 子量表平均（SD）改善无显著差异（7.5[12.7]比 6.5[9.9]；=.67）。PG 组和安慰剂组之间的 QoL、焦虑、抑郁、症状和功能评分无显著差异。FACIT-F 子量表的改善与基线评分相关（=0.0005）、医院焦虑和抑郁量表结果相关（=0.032）和性别相关（=0.023）。PG 组与安慰剂组相比，任何等级的毒性反应发生率较低（28/63 比 33/64；=.024）。 PG 和安慰剂均可显著改善 CRF。在 4 周的治疗后，PG 并不显著优于安慰剂。没有理由推荐使用 PG 治疗 CRF。需要进一步的研究。 ClinicalTrials.gov 标识符：NCT01375114。
