Efficacy of Hand Cooling and Compression in Preventing Taxane-Induced Neuropathy: The POLAR Randomized Clinical Trial.

Currently, there is no established strategy for prevention or treatment.

目前，尚无确立的预防或治疗方法。

Background

To compare the effectiveness of 1-sided hand cooling and compression for preventing CIPN in patients with primary breast cancer receiving taxane-based chemotherapy.

比较单侧手部冷却和压迫在预防接受紫杉烷类化疗的原发性乳腺癌患者CIPN中的有效性。

DESIGN, SETTING, AND PARTICIPANTS: The POLAR randomized clinical trial was conducted at the National Center for Tumor Diseases Heidelberg between November 2019 and January 2022.

设计、地点和参与者：POLAR随机临床试验于2019年11月至2022年1月在海德堡国家肿瘤疾病中心进行。

Female patients with breast cancer who received weekly nab-paclitaxel-based or paclitaxel-based neoadjuvant or adjuvant chemotherapy were enrolled.

招募了接受每周紫杉醇或紫杉醇基新辅助或辅助化疗的乳腺癌女性患者。

Patients with prior chemotherapy, preexisting neuropathy, or neuropathy-related comorbidities were excluded.

排除了既往接受过化疗、有既往神经病变或与神经病变相关的合并症的患者。

Methods

Patients were randomized 1:1 to cooling or compression of the dominant hand.

患者被随机分为1:1，对优势手进行冷却或压迫。

No intervention was performed on the other hand.

对另一只手不进行任何干预。

Cooling was performed with a frozen glove and compression was applied by 2 surgical gloves (1 size smaller than the tight-fitting size) 30 minutes before, after, and during taxane administration.

在紫杉醇给药前30分钟、给药后和给药期间，通过使用比紧身尺寸小一号的两个手术手套进行冷却和施加压迫。

main_outcomes_and_measures

The primary end point was the efficacy to prevent grade 2 or higher sensory CIPN evaluated by Common Terminology Criteria for Adverse Events, version 5.0.

主要终点是通过不良事件通用术语标准第5.0版评估的预防2级或更高感官CIPN的疗效。

Further CIPN assessment included the clinical version of the Total Neuropathy Score and QLQ CIPN20.

进一步的化疗相关周围神经病变（CIPN）评估包括临床版的总神经病变评分和QLQ CIPN20量表。

CIPN rates were compared between intervention groups.

比较了不同干预组之间的CIPN发生率。

Nail toxic effects, quality of life, CIPN-associated dose reductions, treatment discontinuations, and risk factors were evaluated.

评估了指甲毒性效应、生活质量、与化疗药物神经毒性相关(CIPN)的剂量减少、治疗中断以及风险因素。

Follow-up examinations were performed 1 week, 1 month, and 6 to 8 months after the last taxane dose.

末次使用紫杉类药物后1周、1个月以及6至8个月进行了随访检查。

Results

A total of 122 female patients with primary breast cancer (mean [SD] age, 50 [12] years) were randomized to either cooling or compression of the dominant hand.

共有122名原发性乳腺癌女性患者（平均[标准差]年龄为50[12]岁）被随机分配至主导手的冷却或压迫治疗组。

Twenty-one individuals withdrew from the study, so 101 patients were included in the final analysis (n = 52 and n = 49 for cooling and compression, respectively).

有21名个体退出了研究，因此最终分析纳入了101名患者（冷却组52人，压迫组49人）。

Both interventions significantly reduced the incidenceof grade 2 or higher CIPN (cooling: 15 participants experiencing high-grade CIPN in the cooling arm [29%] vs 26 in the control arm [50%]; P = .002; effect size, 21.15% [95% CI, 5.98%-35.55%]; compression: 12 participants experiencing CIPN in the intervention arm [24%] vs 19 in the control arm [38%]; P = .008; effect size, 14.29% [95% CI, 2.02%-27.24%]).

两种干预措施显著降低了2级或更高级别CIPN的发生率（冷却组：29%的参与者（15人）在冷却组出现高级别CIPN，对照组为50%（26人）；P = .002；效应量为21.15% [95% 置信区间，5.98%-35.55%]；压迫组：24%的参与者（12人）在干预组出现CIPN，对照组为38%（19人）；P = .008；效应量为14.29% [95% 置信区间，2.02%-27.24%]。）

CIPN was the main reason for treatment discontinuations in 16 of 24 participants (67%).

CIPN是24名参与者中16名（67%）治疗中断的主要原因。

The predominant risk factors were the cumulative taxane dosage and the neurotoxic agent.

主要风险因素是累积的紫杉类药物剂量和神经毒性药物。

Participants experiencing grade 2 or higher CIPN showed a reduced global health status during and 6 to 8 months after taxane therapy.

经历2级或更高级别CIPN的参与者在紫杉类药物治疗期间及治疗后6到8个月内显示出全球健康状况下降。

conclusions_and_relevance

In this randomized clinical trial, cooling and compression were highly effective and significantly reduced the risk of high-grade CIPN.

在这项随机临床试验中，冷却和压迫治疗非常有效，并显著降低了高级别CIPN（化疗相关周围神经病变）的风险。

trial_registration

ClinicalTrials.gov Identifier: NCT06541769.

ClinicalTrials.gov注册号：NCT06541769。