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
Jinsong Lu
Chief of Department of Breast Surgery
RenJi Hospital
研究点 (1)
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