Effectiveness of L-carnitine on paclitaxel induced myopathy and peripheral neuropathy in breast cancer patients : A randomized, double blind, placebo-controlled trail.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum Creatine kinase MM (CK MM) and
研究概览
简要总结
It was evident that the patient receiving Paclitaxel as a first-line chemo therapeuticagent tend to
develop myopathy on successive chemo-cycle.
This myopathic condition expedite the reduction of quality of life of the patient receiving
paclitaxel.
The patient experience severe muscle fatigue and loss of strength which affects the daily
activityof the patient and increase risk of fall by several folds.
L-carnitine which is an energy sparing over the counter supplement works by producing energy
(ATP) from the reserved fat in the body.
The so-called ATP aids in providing energy and reduce the muscle fatigue.
Ubiquitin proteasome system plays a role in protein breakdown in tissues. L-carnitine act on
this system and prevents protein breakdown thereby prevent muscle loss and myopathy.
L-Carnitine even improves the peripheral neuropathy by decreasing the numbness and pricking
pain. Hence, we have designed an interventional trial to evaluate the effect of L-carnitine on
paclitaxel induced myopathy and peripheral neuropathy in breast cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.patients with pre-existing myopathy and peripheral neuropathy induced by paclitaxel and those have high risk for developing these are included.
- •2.patients willing to give informed consent.
排除标准
- •1.patients with history of ESRD and are excluded.
- •2.patients with peripheral neuropathy and myopathy precipitated by other disease and drugs are excluded.
结局指标
主要结局
Serum Creatine kinase MM (CK MM) and
时间窗: Baseline and week 26
Nerve conduction study
时间窗: Baseline and week 26
次要结局
未报告次要终点
研究者
Dr Duraimavalavan
SRM Medical College Hospital and Research centre,