NCT06763575招募中不适用
Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.
研究概览
简要总结
The aim of this randomized controlled trial (RCT) is to compare the incidence of paclitaxel-induced grade 2 or higher sensory peripheral neuropathy, evaluated using the CTCAE version 5.0, between patients receiving surgical glove-compression therapy (SGCT) and those in the control group.
The main question is whether SGCT is effective in preventing paclitaxel-induced sensory peripheral neuropathy.
- Intervention group: receive SGCT.
- Control group: receive non-compressive plastic gloves.
详细描述
- The study aims to test the hypothesis that SGCT is effective in preventing paclitaxel-induced peripheral neuropathy.
- The primary objective is to determine the incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy, assessed using the CTCAE version 5.0. Secondary objectives include evaluating the incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE version 5.0, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) score, the incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy as measured by the Patient Neurotoxicity Questionnaire (PNQ), and the outcomes from the monofilament test.
- Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 36 patients.
- Randomization into two groups. The intervention arm will receive SGCT, while the control arm will receive non-compressive plastic gloves. The duration of treatment is 9 weeks.
- Enrollment and data monitoring are assessed by staff at the Oncology Unit, Rajavithi Hospital, and the data will be recorded in a computer-based information system.
- Data assessment will be conducted on weeks 0, 3, 6, and 9 during the chemotherapy treatment.
- Data analyzed by descriptive and inferential statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed Informed Consent Form
- •Age 18 years or older at the time of signing Informed Consent Form
- •Patients with any pathological diagnosis of solid tumor, such as breast cancer or lung cancer
- •Patients scheduled to be receiving intravenous paclitaxel or paclitaxel-based regimen every 3 weeks
排除标准
- •Patients whose received chemotherapeutic agents that could cause neuropathy, e.g. taxane-based or platinum-based chemotherapy and anti-microtubule
- •History of neuropathy
- •History of carpal tunnel syndrome
- •History of allergic reactions to latex or gloves
- •Patients receiving treatments that may treat neuropathy, e.g. amitriptyline, gabapentin, Acetyl L-Carnitine and Ganglioside-monosialic acid, acupuncture, cryotherapy or exercise therapy
- •History of Raynaud phenomenon
- •History of wounds or large scars on hands
- •Pregnancy or breastfeeding
- •History of poorly controlled diabetes; HbA1c>6.5
结局指标
主要结局
Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.
时间窗: 9 weeks
The incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy was evaluated using the CTCAE version 5.0 for both the intervention and control groups.
次要结局
- Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0(9 weeks)
- FACT/GOG-NTX scores(9 weeks)
- Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ(9 weeks)
- Monofilament test results(9 weeks)
研究者
研究点 (2)
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