Comparison of Surgical Glove Compressions as a Prophylactic Method to Prevent Paclitaxel-induced Peripheral Neuropathy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
研究概览
简要总结
This study aims to evaluate the effect of surgical glove compression as a prophylactic method to prevent paclitaxel-induced peripheral neuropathy. Participants will be randomly assigned to two groups: one receiving standard care, and the other receiving prophylactic surgical glove compression. The study will compare the development, severity of neuropathy in the hands and fingers, and its impact on quality of life.
详细描述
This study aims to evaluate the effectiveness of surgical glove compression to prevent peripheral neuropathy in patients receiving paclitaxel. Participants will be divided into two groups: one receiving standard care, and the other receiving glove compression. The study will compare the development and severity of neuropathy in the hands and fingers, as well as its impact on quality of life. This method is considered a practical, cost-effective, and well-tolerated preventive approach.
Method:
Patients receiving paclitaxel will be randomly assigned to either the intervention or control group.
Intervention Group 1: Each patient will wear a standard surgical glove (½ size smaller) on the same hand for all treatment sessions. Since surgeons typically use gloves that fit their hands perfectly, a standard-sized surgical glove is defined as a "surgeon fit." Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after the infusion. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient by measuring from the base of the palm to the tip of the middle finger. The measurements will be converted to glove sizes using a reference table.
Intervention Group 2: Each patient will wear two standard surgical gloves on the same hand: the first ½ size smaller and the second one size smaller. Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In addition to participants and study staff, outcome assessors and data analysts will be blinded to group assignments to minimize bias in evaluating peripheral neuropathy and quality of life outcomes.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years
- •Diagnosed with Stage II-III breast cancer
- •No distant metastasis
- •Planned to receive adjuvant or neoadjuvant paclitaxel for at least 12 weeks
- •Willing and able to provide informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Karnofsky ≥ 60%)
排除标准
- •Recurrent breast cancer
- •Prior treatment associated with neuropathy (e.g., taxanes, platinum-based chemotherapy, anti-tubulin or proteasome inhibitors)
研究组 & 干预措施
Intervention Group 2
Two standard surgical gloves will be worn on the same hand: first ½ size smaller, second 1 size smaller. Gloves will be worn 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove sizes determined by study nurse.
干预措施: Surgical glove compression during paclitaxel infusion (Other)
Intervention Group 1
A standard surgical glove (½ size smaller) will be worn on the same hand 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove size will be determined by the study nurse based on hand measurements.
干预措施: Surgical glove compression during paclitaxel infusion (Other)
Control Group
Patients will receive standard clinical care only, with no additional intervention.
干预措施: Surgical glove compression during paclitaxel infusion (Other)
结局指标
主要结局
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
时间窗: 4 weeks after the first assessment
The first section assesses the nine main symptoms as well as their severity, the extent to which they cause emotional disruption, and the frequency of their occurrence. The first six items in this section are related to sensory symptoms, while the seventh, eighth and ninth items are related to sub-dimensions of motor symptoms. In the second part, 14 activities were evaluated and questions were asked about the effect level of these substances. The activities assessed included fine motor and general activities. To assess the symptoms listed in the first section, "Yes" was considered equal to 1 point and "No" equal to 0 (0-9); their severity, symptoms, extent and frequency of emotional impairment were scored between 0 and 10 (0-270). The total score for the first part of the instrument is between 0 and 279. The effect level on the 14 activities in the second part was calculated between 0 and 10 (0-140). The Cronbach's alpha value of the original scale is 0.95
次要结局
未报告次要终点
研究者
Deniz Ozdemir
PHD
Konya City Hospital
