Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Difference in change in CIPN score due to paclitaxel analogues compared to baseline
研究概览
简要总结
The goal of this study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed breast cancer by pathology
- •Age 18-60 years
- •CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs
排除标准
- •Patients with contraindications to hyperbaric oxygen i. Untreated pneumothorax. ii. concomitant administration of disulfiram. iii. concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. iv. premature and/or low body mass newborns.
- •iv. Premature and/or low body mass neonates.
- •Other cancers
研究组 & 干预措施
Hyperbaric Oxygen group
Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times and administration of pressurised ice gloves 30 minutes before, during and 30 minutes after the administration of paclitaxel-based chemotherapeutic agents.
干预措施: hyperbaric oxygenation treatment (Device)
Hyperbaric Oxygen group
Administration of 100% oxygen at a pressure of 2.0ATA once daily for 60-90 minutes for a total of 30-40 times and administration of pressurised ice gloves 30 minutes before, during and 30 minutes after the administration of paclitaxel-based chemotherapeutic agents.
干预措施: routine care (Behavioral)
Control group
Administration of pressurised ice gloves 30 minutes before, during, and 30 minutes after administering paclitaxel chemotherapy drugs.
干预措施: routine care (Behavioral)
结局指标
主要结局
Difference in change in CIPN score due to paclitaxel analogues compared to baseline
时间窗: Baseline, 2 week, 4 week, 6 week, 8 week
Difference in change in CIPN score due to paclitaxel analogues compared to baseline
次要结局
- insomnia score(Baseline, 2 week, 4 week, 6 week, 8 week)
- neuromyography(Baseline, 8 week)
- NPS degree(Baseline, 2 week, 4 week, 6 week, 8 week)
- ENS score(Baseline, 2 week, 4 week, 6 week, 8 week)
- EORTC QLQ - CIPN20(Baseline, 2 week, 4 week, 6 week, 8 week)
- life quality(Baseline, 2 week, 4 week, 6 week, 8 week)
- Side effects of hyperbaric oxygen therapy(during the hyperbaric oxygen therapy (up to 2 months))
- depression score(Baseline, 2 week, 4 week, 6 week, 8 week)
- Exhaustion score(Baseline, 2 week, 4 week, 6 week, 8 week)
研究者
Kun Wang
Professor
Guangdong Provincial People's Hospital