Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- EORTC QLQ-CIPN20 subscales
研究概览
简要总结
The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years and ≤ 75 years, female
- •early-stage breast cancer or locally advanced breast cancer
- •Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel
- •The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4/
- •The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.
排除标准
- •Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.
- •Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.
- •Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).
- •Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.
- •Karnofsky Performance Status score < 80
- •Patients with any other conditions that the investigator deems unsuitable for participation in the study.
研究组 & 干预措施
HBOT group
hyperbaric oxygen intervention：Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)
干预措施: Hyperbaric oxygen treatment (Device)
Control group
Standard care
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
EORTC QLQ-CIPN20 subscales
时间窗: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
Self-reported neuropathy was assessed with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20, which contains 20 items divided into three subscales assessing sensory, motor and autonomic symptoms. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much'. Scores were transformed to a 0-100 scale, with higher scores representing more complaints
次要结局
- NCI-CTCAE 5.0(baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended)
- EORTC QLQ-C30(baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended)
- BPI-SF(baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended)
- Nerve Conduction Velocity(baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended)
研究者
Kun Wang
Professor
Guangdong Provincial People's Hospital