Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Measure of average pain intensity by a numerical rating scale
研究概览
简要总结
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
详细描述
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing dextromethorphan and placebo for the treatment of chemotherapy-induced peripheral neuropathy, assessed with a (0-10) numerical scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.
The influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Age ≥ 18 years
- •Breast cancer patients suffering from chemotherapy-induced peripheral neuropathy for at least 3 months after the end of their last cancer chemotherapy
- •Numerical rating scale ≥ 4
- •Patient in stable clinical situation on the next month (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled in the month following the enrollment)
- •Patients affiliated to the French Social Security
- •Patients with free and informed consent has been obtained
排除标准
- •- Hypersensitivity to the active substance or to any of the excipients
- •Hypertension
- •History of stroke
- •Severe heart failure
- •Severe hepatic impairment
- •Shortness of breath
- •Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
- •Association with linezolid
- •Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
- •Diabetes (type I and II)
- •Medical and surgical history incompatible with the study
- •Patient receiving treatment with amantadine, ketamine, memantine, L-Dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, Monoamine oxidase inhibitor, dantrolene or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, amiodarone, fluoxetine, paroxetine, propafenone, thioridazine, ritonavir, nicotine, hydrochlorothiazide, warfarin
- •Present or past psychotropic substances and alcohol dependence
- •Childbearing age, no use of effective contraceptive method, pregnancy or lactation
- •Patient exclusion period, or the total allowable compensation exceeded
- •Patients undergoing a measure of legal protection (guardianship, supervision ...)
研究组 & 干预措施
Dextromethorphan
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
干预措施: Dextromethorphan (Drug)
placebo
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
干预措施: Dextromethorphan (Drug)
结局指标
主要结局
Measure of average pain intensity by a numerical rating scale
时间窗: 7 days before the visit at 1 month
次要结局
- Evaluation of analgesic consumption(at 1 month)
- Cognitive assessment by Trail Making Test A and B(at 1 month)
- Cognitive assessment by FACT-COG test(at 1 month)
- Quality of life assessment by EORTC QLQ-C30(at 1 month)
- total neuropathy score clinical version (TNSc)(at 1 month)
- St Antoine questionnaire (QDSA)(at 1 month)
- Cognitive assessment by Digit Symbol Substitution Test(at 1 month)
- Pain assessment by DN4(at 1 month)
- Cognitive assessment by Purdue Pegboard Test(at 1 month)
- Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)(at 1 month)
- Quality of life assessment by Patient Global Impression of Change (PGIC)(at 1 month)
- Anxiety and Depression assessment by HAD scale(at 1 month)