Chemotherapy-induced peripheral neuropathy

化疗引起的周围神经病变
  • 文章类型: Journal Article
    化疗引起的周围神经病变(CIPN)仍然缺乏有效的治疗药物。本研究旨在系统评价黄芪桂枝五物汤(HGWD)单独或联合阳性药物对CIPN防治的效果。
    PubMed,Embase,WebofScience,科克伦,中国国家知识基础设施(CNKI),万方数据,在中国科学技术杂志(VIP)和中国生物医学(CBM)数据库中搜索HGWD用于CIPN预防和治疗的随机对照试验(RCT)。搜索时间从数据库建立到2023年10月17日不等。Cochrane偏差风险评估工具用于质量评估,ReviewManager5.3和STATA12.0用于荟萃分析,和GRADEprofiler用于证据水平评估。
    共32个RCT,涉及1987名患者。荟萃分析结果显示:1.就总CIPN发生率而言,HGWD组低于空白对照组。HGWD和HGWD阳性药物组的发生率均低于单药阳性药物组。2.就严重CIPN的发生率而言,HGWD组低于空白对照组和阳性药物组。HGWD+阳性药物组与阳性药物组之间无统计学差别。敏感性分析显示,HGWD组的严重发生率低于阳性药物组3。HGWD没有增加化疗相关不良事件的数量。
    HGWD可以安全有效地预防CIPN,减少症状,提高生活质量,减少化疗药物对感觉神经传导的影响。然而,需要更多高质量的RCT来比较HGWD与阳性对照药物预防严重CIPN的疗效.
    UNASSIGNED: Chemotherapy-induced peripheral neuropathy (CIPN) still lacks efficient therapeutic drugs. This study aimed to systematically evaluate the effects of Huangqi Guizhi Wuwu Decoction (HGWD) alone or combined with positive drugs on CIPN prevention and treatment.
    UNASSIGNED: The PubMed, Embase, Web of Science, Cochrane, China National Knowledge Infrastructure (CNKI), Wan Fang Data, China Science and Technology Journal (VIP) and Chinese Biomedical (CBM) databases were searched for randomized controlled trials (RCTs) of HGWD for CIPN prevention and treatment. The search time ranged from database establishment to October 17, 2023. The Cochrane risk-of-bias assessment tool was used for quality assessment, Review Manager 5.3 and STATA 12.0 were used for meta-analysis, and GRADEprofiler was used for evidence level assessment.
    UNASSIGNED: A total of 32 RCTs involving 1987 patients were included. The meta-analysis results revealed the following: 1. In terms of the total CIPN incidence, that in the HGWD group was lower than that in the blank control group. The incidence in both the HGWD and HGWD+positive drug groups was lower than that in the monotherapy-positive drug group. 2. In terms of the incidence of severe CIPN, that in the HGWD group was lower than that in the blank control and positive drug groups. There was no statistically significant difference between the HGWD+positive drug and positive drug groups. Sensitivity analysis revealed that the results of severe incidence in the HGWD group was lower than that in the positive drug group were unstable 3. HGWD did not increase the number of chemotherapy-related adverse events.
    UNASSIGNED: HGWD can safely and effectively prevent CIPN, reduce symptoms, improve quality of life and reduce the impact of chemotherapy drugs on sensory nerve conduction. However, more high-quality RCTs are needed to compare the efficacy of HGWD with that of positive control drugs in preventing severe CIPN.
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  • 文章类型: Journal Article
    目的:本研究旨在证明在预防化疗引起的2级或以上周围神经病变(CIPN)方面,冷冻压缩优于单独的冷冻疗法。
    方法:这项前瞻性随机研究于2020年5月至2023年1月在因斯布鲁克进行。符合条件的患者诊断为妇科癌症,并接受了至少3个周期的基于紫杉烷的CT(新辅助,辅助或姑息治疗)。在化疗(CT)期间,患者以1:1的比例随机分配给上肢接受冷冻治疗或冷冻压缩。我们进行了温度测量,在CT期间以及CT完成后3个月和6-9个月的随访期间,进行了两次QoL问卷和神经学检查。使用CTCAE评分评估CIPN。
    结果:在招募的200名患者中,与最近的文献相比,两组在本研究中的CIPN患病率均较低.在接受冷冻治疗的组中,1CIPN的患病率为30.1%,2CIPN或以上等级为13.7%;在冷冻压缩治疗组中,1CIPN的患病率为32.8%,二级及以上CIPN为17.2%。我们发现冷冻疗法和冷冻压缩组的温度显着降低。关于两个QOL问卷以及神经学测试,两组之间没有发现显着差异。
    结论:我们的研究表明,冷冻治疗和冷冻压缩是一种安全有效的方法,可以使患者四肢降温,从而降低CIPN的患病率。在预防CIPN方面,冷冻压缩并不比单独的冷冻疗法更有效。
    OBJECTIVE: This study aimed to demonstrate the superiority of cryocompression over cryotherapy alone in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) grade 2 or above.
    METHODS: This prospective randomized study was conducted between May 2020 and January 2023 in Innsbruck. Eligible patients had a diagnosis of gynecological cancer and received a minimum of 3 cycles of taxane-based CT (neoadjuvant, adjuvant or palliative therapy). Patients were randomized 1:1 to receive either cryotherapy or cryocompression on their upper extremities during chemotherapy (CT). We performed temperature measurements, two QoL questionnaires and neurological tests during CT and at follow-up 3 and 6-9 months after the completion of CT. CIPN was assessed using the CTCAE score.
    RESULTS: Of 200 patients recruited, both groups showed a lower prevalence of CIPN in this study compared to recent literature. In the group receiving cryotherapy, the prevalence of grade 1 CIPN was 30.1 %, and that of grade 2 CIPN or above was 13.7 %; in the group treated with cryocompression, the prevalence of grade 1 CIPN was 32.8 %, and that of grade 2 or above CIPN was 17.2 %. We found a significant reduction in temperature in the cryotherapy and cryocompression groups. Regarding the two QOL questionnaires as well as the neurological tests no significant differences were found between the two groups.
    CONCLUSIONS: Our study suggests that cryotherapy as well as cryocompression is a safe and effective way to cool patients\' extremities to lower the prevalence of CIPN. Cryocompression was not more effective than cryotherapy alone in the prevention of CIPN.
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  • 文章类型: Journal Article
    背景对于接受紫杉烷抗有丝分裂药物的乳腺癌患者,化疗诱导的周围神经病变(CIPN)是一个有问题的不良事件。我们评估了接受紫杉烷类药物的乳腺癌患者下肢压迫治疗对CIPN的有效性。方法选择围手术期接受紫杉烷类药物治疗的早期乳腺癌患者。每个病人都戴着不含乳胶的手术手套和压缩袜,在施用紫杉烷类前15分钟穿上两层,并在施用后15分钟去除它们。使用不良事件通用术语标准(CTCAE)4.0版和患者神经毒性问卷(PNQ)评估周围神经病变(PN)。主要终点是在整个紫杉烷类围手术期化疗期间,下肢CTCAE4.0版本2级或较高CIPN的发生率。结果CTCAE对下肢的PN评估,主要结果,显示13.3%发展为2级感觉障碍,8.3%发展为2级电机扰动。在整个研究期间,手部CTCAE2级或更高PN的发生率为感觉障碍的26.7%,运动障碍的发生率为13.3%。没有患者有3级或更高的PN。没有观察到由于压迫治疗引起的不良事件。结论与一般情况相比,用压缩袜压缩下肢有降低CIPN发生率的趋势。压迫治疗可能有助于预防CIPN的发展。
    Background Chemotherapy-induced peripheral neuropathy (CIPN) is a problematic adverse event for breast cancer patients receiving taxane antimitotic agents. We evaluated the effectiveness of compression therapy against CIPN in the lower extremities of breast cancer patients receiving taxanes. Methods Eligible patients scheduled for perioperative treatment with taxanes for early-stage breast cancer were enrolled. Each patient wore latex-free surgical gloves and compression socks, putting on two layers of each 15 minutes before the administration of taxanes and removing them 15 minutes after administration. Peripheral neuropathy (PN) was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and the Patient Neurotoxicity Questionnaire (PNQ). The primary endpoint was the incidence of CTCAE version 4.0 grade 2 or higher CIPN in the lower extremities during the entire period of perioperative chemotherapy with taxanes. Results PN assessment by CTCAE in the lower extremities, the primary outcome, showed that 13.3% developed grade 2 sensory disturbances, and 8.3% developed grade 2 motor disturbances. The incidence of CTCAE grade 2 or higher PN in the hands was 26.7% for sensory disturbances and 13.3% for motor disturbances during the entire study period. No patient had grade 3 or higher PN. No adverse events due to compression therapy were observed. Conclusion Compression of the lower extremities with compression socks tended to reduce the incidence of CIPN compared to the general incidence. Compression therapy may help prevent the development of CIPN.
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  • 文章类型: Journal Article
    背景:化疗(CT)仍然是上皮性卵巢癌(EOC)引起的持续性周围神经病变(CIPN)的主要治疗方法。使用专用的患者报告结果工具,这项研究调查了长期EOC幸存者队列中的持续性CIPN及其药物遗传学预测因子.
    方法:Vivrovaire是法国多中心队列研究,研究了CT完成后3年无疾病的EOC患者。使用FACT/GOG-Ntx4自我问卷评估PersistentCIPN。评估了所选基因中纯合(hom)或杂合(het)单核苷酸多态性(SNP)的关联。
    结果:130例患者被纳入,CT完成的中位时间为63[35-180]个月。medianCIPN得分为37[18-44],35例(26.9%)患者报告严重CIPN(<33)。SNP鉴定如下:CYP2C8[hom,n=32(24.6%)/het,n=99,(76.2%)];CYP3A4[hom,n=0(0%)/het,n=8(6.2%)],ERCC1[hom,n=21(16.2%)/het,n=57(43.8%)],和XPC[hom,n=45(34.6%)/het,n=66(50.8%)]。在单变量分析中,≥1个homSNP的鉴定与较低的CIPN评分相关(连续变量;p=0.045).携带hom或hetCYP2C8_rs1934951SNP的患者报告更可能严重CIPN(阈值<33)评分(OR2.482;95%CI[1.126-5.47],p=0.024)。在多变量分析中,年龄,从CT完成的间隔,CT病程的类型和数量与CIPN评分无显著相关(OR5.165,95%CI[0.478-55.83],p=0.176)。
    结论:持续CIPN在卵巢癌长期存活者中很常见。CYP2C8_rs1934951SNP可能与EOC幸存者的严重残留CIPN相关。有必要进行更多的研究来确定CIPN的预测因素。
    Chemotherapy (CT) remains a backbone treatment of epithelial ovarian cancer (EOC) inducing persistent peripheral neuropathy (CIPN). Using a dedicated patient-reported outcome tool, this study investigated persistent CIPN and its pharmacogenetic predictors in a cohort of long-term EOC survivors.
    Vivrovaire was a French multicenter cohort of patients with EOC free of disease 3 years after CT completion. Persistent CIPN was assessed using the FACT/GOG-Ntx4 self-questionnaire. The association of homozygous (hom) or heterozygous (het) single nucleotide polymorphisms (SNPs) in selected genes was evaluated.
    130 patients were included with a median time from CT completion of 63 [35-180] months. The median CIPN score was 37 [18-44], with 35 (26.9%) patients reporting severe CIPN (<33). SNPs were identified as follows: CYP2C8 [hom, n = 32 (24.6%)/het, n = 99, (76.2%)]; CYP3A4 [hom, n = 0 (0%)/het, n = 8 (6.2%)], ERCC1 [hom, n = 21 (16.2%)/het, n = 57 (43.8%)], and XPC [hom, n = 45 (34.6%)/het, n = 66 (50.8%)]. In univariate analysis, the identification of ≥1 hom SNP was associated with a lower CIPN score (continuous variable; p = 0.045). Patients harboring hom or het CYP2C8_rs1934951 SNP reported more likely severe CIPN (threshold <33) score (OR 2.482; 95% CI [1.126-5.47], p = 0.024). In the multivariate analyses, age, interval from CT completion, type and number of CT courses were not significantly associated with CIPN score (OR 5.165, 95% CI [0.478-55.83], p = 0.176).
    Persistent CIPN is common among ovarian cancer long-term survivors. CYP2C8_rs1934951 SNP may be associated with severe residual CIPN in EOC survivors. More studies are warranted to identify predictive factors of CIPN.
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  • 文章类型: Journal Article
    目的:探讨血液肿瘤幸存者在日常生活中化疗引起的周围神经病变(CIPN)的经历。
    方法:通过对12名在完成治疗后经历CIPN的血液学癌症幸存者的个人半结构化访谈来产生数据。采用专题分析法对数据进行分析。
    结果:主题分析对CIPN症状的经历以及症状对日常生活的影响进行了深入的描述。分析中出现了四个主要主题:(1)在日常生活中无法忽视的弥散和矛盾的感觉,(2)感觉不舒服,即使我治好了,(3)与CIPN生活在一起,尽管有局限性,(4)一个看不见的伴侣,每个人都知道。
    结论:研究结果表明,血液癌症的生存率并不总是等于幸福感,作为经验CIPN对日常生活有广泛的影响。CIPN影响血液学癌症幸存者向普通日常生活的过渡,身体功能受到干扰,日常活动,社会关系,心理方面,和工作能力。作为一种分散和矛盾的症状,CIPN似乎是一个看不见的伴侣,导致一种孤独的感觉。
    结论:对血液病癌症幸存者日常生活中的CIPN经验的更好和更深入的了解可能会改善沟通,指导,以及CIPN症状的治疗。结果表明,需要采取干预措施和策略来适应实践中的差距,并解决CIPN在日常生活中的影响。
    OBJECTIVE: To explore haematological cancer survivors\' experience of chemotherapy-induced peripheral neuropathy (CIPN) in everyday life.
    METHODS: Data were generated by means of individual semi-structured interviews with 12 haematological cancer survivors who experience CIPN after completion of treatment. Data were analysed using thematic analysis.
    RESULTS: The thematic analysis yielded an in-depth description of the experience of CIPN symptoms and the influence of the symptoms on everyday life as being unwell despite being cured. Four main themes emerged from the analysis: (1) A diffuse and contradictory sensation which is impossible to ignore in everyday life, (2) Not feeling well, even though I\'m cured, (3) Living with CIPN, despite limitations, and (4) An invisible companion, that everybody knows about.
    CONCLUSIONS: The findings shows that survival from haematological cancer does not always equal well-being, as experiencing CIPN has extensive consequences on everyday life. CIPN affects haematological cancer survivors\' transition to an ordinary everyday life, with disturbances in the physical function, daily activities, social relationships, psychological aspects, and work ability. As a diffuse and contradictory symptom, CIPN appears as an invisible companion that leads to a feeling of being alone.
    CONCLUSIONS: A better and deeper understanding of haematological cancer survivors\' experience of CIPN in everyday life may improve communication, guidance, and treatment of CIPN symptoms. The results suggest a need for interventions and strategies to accommodate the gap in practice and to address the impact of CIPN in everyday life.
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  • 文章类型: Journal Article
    HIV相关非霍奇金淋巴瘤的一线免疫化疗方案是剂量调整的EPOCH±R(依托泊苷,泼尼松,长春新碱,环磷酰胺,阿霉素,和利妥昔单抗)。化疗诱导的周围神经病变(CIPN),由长春新碱引起,是EPOCH±R的常见不良反应,对患者的长期预后产生负面影响。这项研究的主要目的是确定CIPN的发生率,按艾滋病毒状况分层,在接受EPOCH±R治疗的患者中,三级转诊综合癌症中心的一项回顾性队列研究评估了2011年至2018年接受EPOCH±R治疗的患者.最终样本包括27名HIV患者,而没有HIV的患者为279名(总计n=306)。总的来说,CIPN的发生率为29.4%(n=90),包括5名HIV感染者(18.5%)和85名HIV感染者(30.5%)。倾向评分用于根据HIV状况匹配患者。尽管没有发现HIV状态和神经病之间的关系,CIPN影响了太多正在接受淋巴瘤治疗的患者,支持未来的调查,以尽量减少毒性。
    The frontline immuno-chemotherapy regimen for HIV-associated non-Hodgkin Lymphoma is dose-adjusted EPOCH ± R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab). Chemotherapy-induced peripheral neuropathy (CIPN), caused by vincristine, is a common adverse effect of EPOCH ± R, negatively impacting long-term patient outcomes. The primary objective of this study was to determine the incidence of CIPN, stratified by HIV status, in patients treated with EPOCH ± R. A retrospective cohort study at a tertiary referral comprehensive cancer center evaluated patients treated with EPOCH ± R from 2011 to 2018. The final sample included 27 patients with HIV compared to 279 without HIV (total n = 306). Overall, the incidence of CIPN was 29.4% (n = 90), including 5 with HIV (18.5%) and 85 without HIV (30.5%). Propensity scores were used to match patients by HIV status. Although no relationship was found between HIV status and neuropathy, CIPN affects too many undergoing treatments for lymphoma, supporting future investigations to minimize toxicities.
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  • 文章类型: Journal Article
    背景:化疗诱导的周围神经病变(CIPN)在癌症幸存者中很常见且致残。关于CIPN与其他神经系统完整性指标的关联知之甚少,如执行功能障碍。我们比较了有和没有CIPN的老年化疗癌症幸存者的执行功能指标。
    方法:这项横断面研究纳入了50名接受化疗的癌症幸存者(65.6±11.5年,88%的女性)化疗后治疗,先前应癌症幸存者或医疗提供者的要求转诊为门诊康复。22名参与者(44%)有患者报告的远端感觉异常或麻木定义的CIPN,从化疗开始,一直持续到认知测试。执行功能的测量包括Trails-B,Stroop,和快速反应准确性(RRA),并使用t检验在有和没有CIPN的癌症幸存者之间进行评估。然后使用多变量模型来确定CIPN是否是执行功能测量的独立决定因素(Trails-B,Stroop不一致,和RRA)。模型根据年龄进行了调整,性别,焦虑史,和苯二氮卓类药物的使用,因为它们与CIPN和执行功能的已知关联。
    结果:患有CIPN(CIPN)的癌症幸存者与没有CIPN(CIPN-)的幸存者相比,在Trails-B(CIPN:84.9s±44.1s,CIPN-:59.1s±22.5s,p=0.01),Stroop(CIPN+:100.6s±38.2s,CIPN-:82.1s±17.3s,p=0.03),和RRA(CIPN+:60.3%±12.9%,CIPN-:70.6%±15.7%,p=0.01)。根据患者报告或坐姿功能,癌症分期严重程度或功能状态没有差异。校正年龄后,在多变量模型中发现CIPN与执行功能降低之间的关联,性别,焦虑,和苯二氮卓用于Trails-B(β:17.9,p=0.046),Stroop(β:16.9,p=0.02),和RRA(β:-0.072,p=0.03)。
    结论:在这个人群中,在接受化疗的老年癌症幸存者中,CIPN与执行功能降低相关。未来的研究需要进一步了解这种初步的关联,因果关系,以及潜在的风险因素。
    BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is common and disabling among cancer survivors. Little is known about the association of CIPN with other measures of the nervous system\'s integrity, such as executive dysfunction. We compared measures of executive function in older chemotherapy-treated cancer survivors with and without CIPN.
    METHODS: This cross-sectional study enrolled 50 chemotherapy-treated cancer survivors (65.6 ± 11.5 years, 88% female) post-chemotherapy treatment who were previously referred for outpatient rehabilitation at the request of the cancer survivor or a medical provider. Twenty-two participants (44%) had CIPN defined by patient-reported distal paresthesia or numbness, which began with chemotherapy and continued to the time of cognitive testing. Measures of executive function included Trails-B, Stroop, and rapid reaction accuracy (RRA) and were evaluated between cancer survivors with and without CIPN using t-tests. Multivariable models were then used to determine whether CIPN was an independent determinant of the measures of executive function (Trails-B, Stroop Incongruent, and RRA). Models were adjusted for age, sex, history of anxiety, and benzodiazepine use due to their known associations with CIPN and executive function.
    RESULTS: Cancer survivors with CIPN (CIPN+) had reduced executive function compared to survivors without CIPN (CIPN-) on Trails-B (CIPN+: 84.9 s ± 44.1 s, CIPN-: 59.1 s ± 22.5 s, p = 0.01), Stroop (CIPN+: 100.6 s ± 38.2 s, CIPN-: 82.1 s ± 17.3 s, p = 0.03), and RRA (CIPN+: 60.3% ± 12.9%, CIPN-: 70.6% ± 15.7%, p = 0.01). There were no differences in cancer stage severity or functional status by patient report or sit-to-stand function. The association between CIPN and reduced executive function was found in multivariable models after adjusting for age, sex, anxiety, and benzodiazepine use for Trails-B (ß:17.9, p = 0.046), Stroop (ß:16.9, p = 0.02), and RRA (ß:-0.072, p = 0.03).
    CONCLUSIONS: In this population, CIPN is associated with reduced executive function in older cancer survivors treated with chemotherapy. Future research is required to further understand this preliminary association, the causality, and the potential risk factors.
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  • 文章类型: Clinical Trial Protocol
    背景:奥沙利铂诱导的周围神经病变(OIPN)一般,特别是疼痛性OIPN是一种使人衰弱的晚期效应,严重影响癌症幸存者的生活质量,并导致可能挽救生命的治疗过早停止。尽管进行了许多尝试,但仍没有预防性治疗和慢性OIPN的有效治疗方法。几种建议的机制之一包括神经炎症作为OIPN的促成因素。含有长链n-3多不饱和脂肪酸(n-3LCPUFA)的鱼油是介导炎症消退的专门促分解介质的前体。我们的主要假设是n-3LCPUFA的高补充将降低OIPN的患病率和严重程度。
    方法:OxaNeuro项目是由研究者发起的,多中心,双盲,随机化,安慰剂对照临床研究。我们将包括120例有资格在结直肠癌手术后接受奥沙利铂辅助治疗的患者。患者将每天接受含有n-3LCPUFA或玉米油的鱼油胶囊,持续8个月。主要终点是8个月时OIPN的患病率,定义为相关症状,包括以下之一:异常神经传导筛查,异常振动阈值测试,异常皮肤活检,或者异常的针刺测试。其他终点包括OIPN相关神经性疼痛的强度和严重程度,患者报告的OIPN症状,生活质量,心理健康症状,身体成分,和认知评估。此外,我们将评估血液样本和皮肤活检中的炎症生物标志物,包括潜在的OIPN生物标志物神经丝光蛋白(NfL),将在每个化疗周期之前进行测量。
    结论:如果鱼油补充剂可以缓解OIPN的患病率和严重程度,它将显著改善接受奥沙利铂的癌症幸存者和姑息癌症患者的生活;它将改善他们的生活质量,通过降低剂量减少或过早停止的需要来优化化疗治疗计划,并有可能提高生存率。
    背景:ClinicalTrial.gov标识符:NCT05404230协议版本:1.2,4月25日。2023年。
    BACKGROUND: Oxaliplatin-induced peripheral neuropathy (OIPN) in general and painful OIPN in particular is a debilitating late effect that severely affects cancer survivors\' quality of life and causes premature cessation of potentially lifesaving treatment. No preventive treatments and no effective treatment for chronic OIPN exist despite many attempts. One of several suggested mechanisms includes neuroinflammation as a contributing factor to OIPN. Fish oil containing long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFAs) are precursors to specialized proresolving mediators that mediate the resolution of inflammation. Our primary hypothesis is that a high supplementation of n-3 LCPUFAs will lower the prevalence and severity of OIPN.
    METHODS: The OxaNeuro project is an investigator-initiated, multicenter, double-blinded, randomized, placebo-controlled clinical study. We will include 120 patients eligible to receive adjuvant oxaliplatin after colorectal cancer surgery. Patients will receive fish oil capsules containing n-3 LCPUFAs or corn oil daily for 8 months. The primary endpoint is the prevalence of OIPN at 8 months defined as relevant symptoms, including one of the following: abnormal nerve conduction screening, abnormal vibration threshold test, abnormal skin biopsy, or abnormal pinprick test. Additional endpoints include the intensity and severity of OIPN-related neuropathic pain, patient-reported OIPN symptoms, quality of life, mental health symptoms, body composition, and cognitive evaluation. Furthermore, we will evaluate inflammatory biomarkers in blood samples and skin biopsies, including the potential OIPN biomarker neurofilament light protein (NfL) which will be measured before each cycle of chemotherapy.
    CONCLUSIONS: If readily available fish oil supplementation alleviates OIPN prevalence and severity, it will significantly improve the lives of both cancer survivors and palliative cancer patients receiving oxaliplatin; it will improve their quality of life, optimize chemotherapeutic treatment plans by lowering the need for dose reduction or premature cessation, and potentially increase survival.
    BACKGROUND: ClinicalTrial.gov identifier: NCT05404230 Protocol version: 1.2, April 25th. 2023.
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  • 文章类型: Clinical Trial Protocol
    背景:化疗诱导的周围神经病变(CIPN)是神经毒性化疗的常见剂量限制性副作用。治疗期间CIPN的急性症状可导致剂量减少和停止。使用电针(EA)治疗已建立的CIPN化疗后的试验显示出一定的疗效。本试验旨在评估在化疗期间使用EA治疗PN的可行性和初步疗效。
    方法:目前的研究是单中心,1:1随机,在悉尼一家三级癌症医院进行的假对照试点研究,澳大利亚,并将招募40例接受紫杉醇辅助或新辅助化疗的早期乳腺癌成年患者。在化疗的前6周内发生CIPN的患者将每周接受一次真正的EA或假EA,持续10周。主要终点是招募和依从率,患者成功致盲并符合随访期。次要终点是CIPN症状从随机化到治疗结束的平均变化,化疗后8周和24周随访时CIPN症状的持续变化,在没有减少或停止剂量的情况下完成12周化疗的受试者比例,针灸预期反应预处理的变化,在治疗和后处理期间。次要终点的主要评估工具将是经过验证的患者报告的结果指标(欧洲癌症生活质量研究和治疗组织化疗诱导的周围神经病变),从随机分组到化疗的第12周。
    背景:研究方案(2021/ETH12123)已由悉尼圣文森特医院的机构人类研究伦理委员会和ChrisO'BrienLifehouse批准。在开始研究相关程序之前将获得知情同意。结果将在同行评审的期刊和科学会议上传播。
    背景:ACTRN12622000081718。
    Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of neurotoxic chemotherapy. Acute symptoms of CIPN during treatment can lead to dose reduction and cessation. Trials using electroacupuncture (EA) to treat established CIPN postchemotherapy have shown some efficacy. The current trial aims to assess the feasibility and preliminary efficacy of using EA to treat CIPN during chemotherapy.
    The current study is a single-centre, 1:1 randomised, sham-controlled pilot study set in a tertiary cancer hospital in Sydney, Australia, and will recruit 40 adult patients with early breast cancer undergoing adjuvant or neoadjuvant paclitaxel chemotherapy. Patients who develop CIPN within the first 6 weeks of chemotherapy will receive either true EA or sham-EA once a week for 10 weeks. The coprimary endpoints are recruitment and adherence rate, successful blinding of patients and compliance with the follow-up period. Secondary endpoints are mean change of CIPN symptoms from randomisation to end of treatment, sustained change in CIPN symptoms at 8-week and 24-week follow-up postchemotherapy, proportion of subjects attaining completion of 12 weeks of chemotherapy without dose reduction or cessation, change in acupuncture expectancy response pretreatment, during treatment and posttreatment. The primary assessment tool for the secondary endpoints will be a validated patient-reported outcome measure (European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy) captured weekly from randomisation to week 12 of chemotherapy.
    The study protocol (2021/ETH12123) has been approved by the institutional Human Research Ethics Committee at St Vincent\'s Hospital Sydney and Chris O\'Brien Lifehouse. Informed consent will be obtained prior to starting study-related procedures. The results will be disseminated in peer-reviewed journals and at scientific conferences.
    ACTRN12622000081718.
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  • 文章类型: Journal Article
    血液生物标志物,包括神经丝轻链(NfL),作为化疗引起的周围神经病变(CIPN)的潜在指标,神经毒性抗癌药物的剂量限制性不良反应。然而,尚未建立用于常规应用或转化研究的血液生物标志物。这项初步研究旨在评估CIPN大鼠模型中有限的一组血液生物标志物及其与神经性疼痛的相关性。通过重复注射奥沙利铂诱导CIPN模型,紫杉醇,硼替佐米,还有长春新碱.电子vonFrey测试用于评估触觉异常性疼痛。抗癌注射后,测定血清中31种蛋白质的浓度。与对照组相比,抗癌治疗的动物异常性疼痛阈值降低。在跨CIPN模型的生物标志物中未观察到一致的修饰。在至少两个CIPN模型中浓度增加的最值得注意的生物标志物是NfL(紫杉醇,长春新碱),MCP-1和RANTES(奥沙利铂,长春新碱)。长春新碱治疗的动物表现出LIX之间的强相关性,MCP-1,NfL,和VEGF浓度和触觉异常性疼痛阈值。没有单一的生物标志物可以推荐作为CIPN相关疼痛的独特指标。由于研究的局限性(每种抗癌药物的单剂量,年轻的动物,和生物标志物的单次测量),需要进一步的研究来定义动力学,特殊性,和MCP-1,RANTES,和NFL。
    Blood biomarkers, including neurofilament light chain (NfL), have garnered attention as potential indicators for chemotherapy-induced peripheral neuropathy (CIPN), a dose-limiting adverse effect of neurotoxic anticancer drugs. However, no blood biomarker has been established for routine application or translational research. This pilot study aimed to evaluate a limited panel of blood biomarkers in rat models of CIPN and their correlations with neuropathic pain. CIPN models were induced through repeated injections of oxaliplatin, paclitaxel, bortezomib, and vincristine. Electronic von Frey testing was used to assess tactile allodynia. Post anticancer injections, serum concentrations of 31 proteins were measured. Allodynia thresholds decreased in anticancer-treated animals compared to controls. No consistent modifications were observed in the biomarkers across CIPN models. The most noteworthy biomarkers with increased concentrations in at least two CIPN models were NfL (paclitaxel, vincristine), MCP-1, and RANTES (oxaliplatin, vincristine). Vincristine-treated animals exhibited strong correlations between LIX, MCP-1, NfL, and VEGF concentrations and tactile allodynia thresholds. No single biomarker can be recommended as a unique indicator of CIPN-related pain. Because of the study limitations (single dose of each anticancer drug, young animals, and single time measurement of biomarkers), further investigations are necessary to define the kinetics, specificities, and sensitivities of MCP-1, RANTES, and NfL.
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