Compression Therapy as a Prophylactic Method Against Paclitaxel-induced Peripheral Neuropathy: a Prospective Self-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Evaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)
研究概览
简要总结
This is a single-center, self-controlled, evaluator-blinded prospective study, which applies pressurized gloves and foot caps to prevent paclitaxel-induced peripheral neuropathy in patients with nasopharyngeal carcinoma.
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
- Single (Outcomes Assessor)
盲法说明
Evaluator blind design was adopted, and all evaluations were made after the participants had received the intervention and withdrawn the intervention. At this time, the blinded evaluator did not know the tribal groups, while both the participants and researchers knew the trial groups.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 70
- •ECOG physical status score: 0-2
- •Newly diagnosed patients who have not received antitumor therapy
- •Nasopharyngeal carcinoma confirmed by pathology
- •Paclitaxel is included in the chemotherapy regimen
- •Laboratory examination results within one week before enrollment should meet the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥80×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal value (2mg/ dL), ALT and AST ≤2× upper limit of normal value
- •Patients voluntarily participate and provide written informed consent
排除标准
- •Patients with peripheral neuropathy, hand-foot syndrome, and dermatomyositis
- •Patients with missing fingers or toes
- •Patients with Raynaud's syndrome and peripheral vascular ischemia
- •Pregnant or lactating women
- •Those considered unsuitable for inclusion by the researcher
研究组 & 干预措施
Group A
Participants wear pressurized gloves and foot caps for 15 minutes before their chemotherapy treatment, during the treatment, and for 15 minutes after it ended.
干预措施: Pressurized gloves and foot caps (Other)
Group B
No intervention was done before and after chemotherapy with paclitaxels.
结局指标
主要结局
Evaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)
时间窗: Pretreatment (baseline=0), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.
The incidence of common adverse event evaluation criteria (CTCAE) 5.0 ≥ 2°CIPN after compression therapy with pressurized gloves and foot caps is used to objectively assess the peripheral neurotoxicity of chemotherapy. The grade of CTCAE 5.0 CIPN before treatment was the baseline (=0). We assess changes from baseline at 15 minutes after the end of each cycle, 3 and 6 months after the end of treatment. (The duration of chemotherapy varies according to the type of paclitaxel and the interval of each cycle of chemotherapy is 21 days). CIPN includes the symptoms of a sensory nerve and motor nerve injury. The symptoms are graded from 1 to 5, indicating none, mild, severe, life-threatening, and death. The higher the grade, the worse the neurotoxicity. The most severe grade is the final grade for each patient.
次要结局
- EORTC QLQ-CIPN20 score(Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.)
- EORTC QLQ-C30 score(Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days), 3 and 6 months after chemotherapy completion.)
- NRS score(Pretreatment（baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.))
研究者
Chen Chunyan
Professor
Sun Yat-sen University