Pilot Study, Single-blind, Candesartan Versus Usual Care of Peripheral Neuropathy Development Induced by Vincristine (PNIV) in Patients Treated for Lymphoma B
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- TNSc score variation between V1 and V4
研究概览
简要总结
Background:
Chemotherapy induced peripheral neuropathy (CIPN) is often painful, and is caused by neurotoxic chemotherapy including vincristine. It is a cause of significant impairment in quality of life in patients surviving to a solid cancer or malignant lymphoma. The only recognized prevention is based on pre-existing neuropathy and early detection of neuropathic signs and symptoms in individuals subjected to neurotoxic chemotherapy, justifying sometimes a change in the therapeutic strategy when other molecules are available. It seems obvious that to identify early markers of CIPN and to develop preventive therapeutic strategies, are priorities for improving patients' quality of life and enable them to follow optimal treatment.
Purpose:
To describe in patients treated for non-Hodgkin's type B malignant lymphoma with multidrug therapy containing vincristine, the impact of candesartan on the occurrence of neuropathy measured by the variation of TNSc (Total Neuropathy Score clinical version, evaluating clinical signs of neuropathy)
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and over and to be treated with Vincristine for non-Hodgkin B lymphoma (first line treatment)
- •All the patients have to be treated with the same chemotherapy protocol (CHOP with or without Rituximab) to avoid confounding factors
- •Normal renal function as measured by CKD-EPI > 30 mmol / min / 1.73 m2
- •Serum potassium < 5.5 mmol / l
- •Systolic arterial pressure > 100 mm Hg (lying and standing position)
- •affiliated with a social security
- •For women of childbearing age: under "highly effective" contraception and negative pregnancy test at inclusion. Highly effective contraception:
- •Combined hormonal contraceptive (containing estrogen and progesterone) (oral, intravaginal, or transdermal) or only progesterone (oral, injectable or implantable),
排除标准
- •Patients with pre-existing neuropathy, Chronic ethylism, HIV infection, etc.
- •Patients under guardianship or unable for another reason to give informed consent.
- •Intolerance to sartans
- •Intolerance to excipients : galactose , lactose.
- •Patients already treated with ACE inhibitors, ARBs or/and diuretics sparing
研究组 & 干预措施
Candesartan
干预措施: Candesartan (Drug)
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
TNSc score variation between V1 and V4
时间窗: Between the base time (V1) and the end of chemotherapy (15 week later).
The primary endpoint in this clinical study is the V1 - V4 variation of the TNSc score TNSc is the Total Neuropathy Score Clinical version scale Validated 7-item TNSc quantifies subjective sensory and motor symptoms, vibration sensation, strength, and reflexes.Items are rated using a 0 to 4 scale and summed to obtain a total score ranging from 0 to 28. Higher scores reflect more severe neuropathy. The evaluation of the TNSc will be performed by a blinded evaluator of the randomization group
次要结局
- Adverse effects(At baseline and each cycle up to 16 week)
- Variation of visual analog scale (VAS)(Between the base time (V1) and 9 week and 15 week later)
- TNSc score variation between V1 and V3(Between the base time (V1) and V3 (9 week later))