跳至主要内容
临床试验/NCT07169864
NCT07169864尚未招募不适用

An Exploratory Self-Controlled Study on the Preventive Effect of the Simple Surgical Glove Compression Technique Against Chemotherapy-Induced Peripheral Neuropathy

Jinsong Lu1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Change in the functional assessment of cancer therapy/gynaecologic oncology group-neurotoxicity (FACT/GOG-Ntx) subscale score(range:-44to44; higher scores indicate better neurotoxicity-related quality of life).

研究概览

简要总结

To evaluate the preventive efficacy of a simple surgical glove compression technique in reducing the incidence and severity of Chemotherapy Induced Peripheral Neuropathy among patients receiving chemotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 years;
  • •Histologically confirmed primary invasive breast cancer;
  • •Planned to receive ≥ 8 weeks of weekly neoadjuvant chemotherapy (utidelone plus cisplatin);
  • •ECOG performance status: 0-1;

排除标准

  • •Distant metastasis;
  • •Presence of sensory or motor neurological disorders, or symptoms related to peripheral neuropathy with CTCAE grade ≥ 2, or currently receiving medication for peripheral neuropathy;
  • •Conditions affecting limb function;
  • •Known allergy to glove materials (e.g., latex)

研究组 & 干预措施

Group with surgical glove compression applied to the dominant hand

Experimental

干预措施: Simple Surgical Glove Compression Technique (Procedure)

结局指标

主要结局

Change in the functional assessment of cancer therapy/gynaecologic oncology group-neurotoxicity (FACT/GOG-Ntx) subscale score(range:-44to44; higher scores indicate better neurotoxicity-related quality of life).

时间窗: From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer

次要结局

  • Incidence of CIPN as determined by changes in tactile sensitivity assessed with the Semmes-Weinstein monofilament test(From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy)
  • Incidence of CIPN according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0(From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy)
  • Change in scores and the sum score of four hand-related items of the FACT/GOG-Ntx subscale (range: -16to+16; higher scores indicate better neurotoxicity-related quality of life).(From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer)
  • The overall change in the FACT/GOG-Ntx subscale score (range: -44to44; higher scores indicate better neurotoxicity-related quality of life)(From baseline to the end of neoadjuvant chemotherapy and 6 months after completion of neoadjuvant chemotherapy)
  • Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores (range: -12to12, higher scores on functional and global health domains indicate better quality of life,; -84to84; while higher(At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy.)
  • Changes in the maximum width and height of the lunula of each finger(At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy.)

研究者

发起方
Jinsong Lu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jinsong Lu

Chief of Department of Breast Surgery

RenJi Hospital

研究点 (1)

Loading locations...

相似试验