Neuro Glove: A Prospective Self-Controlled Study of Glove Compression as a Protective Strategy Against Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the Intervention vs. Control Hand
研究概览
简要总结
This study investigates whether wearing tight-fitting surgical gloves on the non-dominant hand could help prevent chemotherapy-induced peripheral neuropathy (CIPN) in women with gynecologic cancers treated with paclitaxel. In this prospective, self-controlled observational study, seventy-six patients wear two tight surgical gloves on their non-dominant hand during each paclitaxel infusion. The dominant hand, without gloves, serves as a control. Neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire at baseline, mid-treatment, and end of treatment. Electromyography (EMG) is performed if clinically indicated.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting, and often persistent adverse effect of taxane-based chemotherapy, particularly in women with gynecologic malignancies. CIPN significantly impairs quality of life and may necessitate chemotherapy dose reductions or discontinuation. Despite its clinical relevance, no pharmacologic agent has been proven to prevent CIPN. Accordingly, non-pharmacologic strategies such as physical compression have gained attention as potential neuroprotective interventions.
This prospective, non-randomized, self-controlled observational study is being conducted at Etlik City Hospital, Ankara, Türkiye. A total of seventy-six female patients aged 18 years or older with histologically confirmed gynecologic cancers (endometrial and ovarian) scheduled to receive six cycles of carboplatin-paclitaxel chemotherapy was enrolled. The intervention involves applying two tight-fitting surgical gloves (one size smaller than standard) to the non-dominant hand starting 30 minutes before each paclitaxel infusion, worn throughout the infusion, and removed 30 minutes afterward. The dominant hand, without compression, serves as an internal control.
Peripheral neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire, a validated tool developed by the European Organisation for Research and Treatment of Cancer. The Turkish version has been previously validated. The CIPN20 includes twenty items scored on a 1 (not at all) to 4 (very much) Likert scale, yielding a total score range from 20 to 80. CIPN20 assessments are conducted at baseline (prior to treatment), after cycle three, and after cycle six. Neurological consultation and electromyography (EMG) are performed only in patients reporting significant neuropathic symptoms and if clinically indicated.
All data collection occurs during routine clinical visits. The study remains entirely non-interventional and is integrated into standard oncology care without additional diagnostic or procedural burdens to participants. The primary objective is to evaluate the feasibility and potential role of glove compression in mitigating CIPN development in the intervention hand compared to the control hand, using validated patient-reported outcome measures.
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
盲法说明
This is an open-label study; no parties are masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years
- •Histologically confirmed gynecologic malignancy (e.g., ovarian, or endometrial cancer)
- •Scheduled to receive carboplatin-paclitaxel chemotherapy administered every 21 days
- •Planned for a total of six chemotherapy cycles
- •ECOG performance status 0-2
- •Ability to provide written informed consent
排除标准
- •Patients receiving neoadjuvant chemotherapy with planned surgery
- •Patients receiving weekly (dose-dense) paclitaxel regimens
- •Prior exposure to neurotoxic chemotherapy agents (e.g., taxanes, platinum compounds, proteasome inhibitors, anti-tubulin agents)
- •History of pre-existing peripheral neuropathy
- •Known allergy to latex or surgical gloves
- •Diagnosed peripheral vascular disease
- •Concurrent use of medications that may mask or modulate neuropathy symptoms (e.g., gabapentinoids, SNRIs, vitamin B complex, alpha-lipoic acid)
- •Clinical diagnosis of diabetic neuropathy or history of alcohol-related neuropathy
- •Raynaud's phenomenon or other cold-sensitive vascular conditions
- •Other neurological disorders that may interfere with neuropathy assessment
- •Refusal or inability to provide informed consent
结局指标
主要结局
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the Intervention vs. Control Hand
时间窗: At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.
Peripheral neuropathy severity will be assessed using the validated EORTC QLQ-CIPN20 questionnaire. The sensory subscale score ranges from 0 to 100, with higher scores indicating worse symptoms. A total score of ≥25 will be defined as grade 2 or higher neuropathy. Each patient will serve as their own control: the non-dominant hand will receive the surgical glove compression intervention, while the dominant hand will not. The difference in incidence of grade ≥2 neuropathy between the two hands will be evaluated. Unit of Measure: Percentage of patients with grade ≥2 neuropathy, defined as a sensory score ≥25 on the EORTC QLQ-CIPN20 (range 0-100; higher scores indicate worse symptoms).
次要结局
- Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by Baseline Weight Loss Status(From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.)
- Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by ECOG Performance Status(From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.)
- Change in EORTC QLQ-CIPN20 Sensory Score Over Time(At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.)
- Change in Quality of Life Based on EORTC QLQ-C30 Global Health Status(From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.)
研究者
Galip Can Uyar
Medical Oncologist, Principal Investigator
Ankara Etlik City Hospital