METHODS: This is a pilot, double-blind, randomized controlled trial of oral minocycline (100 mg BID) versus placebo for chemotherapy-induced affective disorders in women initiating chemotherapy for stage I-III BC. Participants received minocycline or placebo up to one week before chemotherapy, continuing through cycle 4 (C4). Epidemiologic Studies Depression Scale (CES-D) and State-Trait Anxiety Inventory (STAI) were assessed at baseline, each cycle of chemotherapy (C1-C4), 2-3-week post-chemotherapy (end of chemotherapy), and 6-month post-chemotherapy (6 M) as the primary outcomes. Sub-group analysis of CES-D and STAI based on the severity of symptoms was also performed. Changes in self-reported cognition and serum inflammatory markers were also evaluated.
RESULTS: Fifty-seven women enrolled and 55 completed the study. Except for Interleukin-8 (p ≤ 0.03), changes in inflammatory markers, cognitive function, CES-D, and STAI were not significantly different between groups from baseline to any cycle or post-chemotherapy time point (all p > 0.05), adjusting for baseline scores. Increases in serum Interleukin-8 from baseline to C4 and 6 M were ameliorated by minocycline (p < 0.05). The sub-group symptomatic for depression (CES-D > = 16 at baseline) treated with minocycline had a greater reduction in CES-D score compared to placebo from baseline to 6 M (p = 0.01).
CONCLUSIONS: Despite attenuation of IL-8, minocycline did not alter self-reported affective symptoms or cognition in this cohort of BC survivors undergoing chemotherapy. The effect of minocycline on BC survivors symptomatic for depression before chemotherapy warrants further investigation.
方法:这是一个试点项目,双盲,口服米诺环素(100mgBID)与安慰剂治疗开始I-III期BC化疗的女性化疗引起的情感障碍的随机对照试验。参与者在化疗前一周接受米诺环素或安慰剂,继续通过周期4(C4)。流行病学研究抑郁量表(CES-D)和状态特质焦虑量表(STAI)在基线时进行评估,每个化疗周期(C1-C4),化疗后2-3周(化疗结束),化疗后6个月(6M)作为主要结果。还进行了基于症状严重程度的CES-D和STAI的亚组分析。还评估了自我报告的认知和血清炎症标志物的变化。
结果:57名妇女参加了这项研究,55名妇女完成了这项研究。除白细胞介素-8(p≤0.03)外,炎症标志物的变化,认知功能,CES-D,从基线到任何周期或化疗后时间点,STAI在组间均无显著差异(均p>0.05),调整基线分数。米诺环素改善了血清白细胞介素-8从基线到C4和6M的增加(p<0.05)。与安慰剂相比,使用米诺环素治疗的有抑郁症症状的亚组(基线CES-D>=16)的CES-D评分从基线降低至6M(p=0.01)。
结论:尽管IL-8减弱,米诺环素在接受化疗的BC幸存者队列中并未改变自我报告的情感症状或认知。米诺环素对化疗前有抑郁症症状的BC幸存者的影响值得进一步研究。