Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer : A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prevalence of Paclitaxel induced CIPN-related pain
研究概览
简要总结
Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as
- Pain
- Burning,
- Tingling ("pins and needles" feeling) or electric/shock-like pain,
- Hyperalgesia,
- Allodynia,
- Increased sensitivity to cold or heat These symptoms are classically seen symmetrically in the distal extremities (glove and stocking distribution).
Most adverse effects associated with chemotherapy are ameliorated after cessation of the therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of neuropathic pain in breast cancer patients has high clinical and public health significance.
详细描述
PRIMARY AIM / OBJECTIVE:
Our study aims to observe the prevalence of CIPN-related pain in cancer breast patients who have received Paclitaxel based adjuvant chemotherapy where we define CIPN-related pain as - "possible" neuropathic pain in patients scoring more than 12 on Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS).
SECONDARY AIM / OBJECTIVE Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as
- Pain
- Burning,
- Tingling ("pins and needles" feeling) or electric/shock-like pain,
- Hyperalgesia,
- Allodynia,
- Increased sensitivity to cold or heat These symptoms are classically seen symmetrically in the distal extremities (glove and stocking distribution).
Most adverse effects associated with chemotherapy are ameliorated after cessation of the therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of neuropathic pain in breast cancer patients has high clinical and public health significance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histopathologically confirmed Primary breast cancer
- •Patients who had received adjuvant chemotherapy with Paclitaxel and who have completed their Paclitaxel chemotherapy within the preceding 2 years i.e. between 1stAugust 2014 to 31st July 2016.
排除标准
- •Age below 18 years
- •On current Paclitaxel chemotherapy
- •Patients with radiological evidence of bone metastases.
结局指标
主要结局
Prevalence of Paclitaxel induced CIPN-related pain
时间窗: 2 years post Paclitaxel Chemotherapy
CIPN-related pain is defined as - neuropathic pain as a result of chemotherapy induced nerve damage . All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN-related pain score will be documented by using the LANSS scale. LANSS score\>12 will be considered as possible CIPN-related pain for statistical analysis
次要结局
- Prevalence of Paclitaxel induced CIPN(2 years post Paclitaxel Chemotherapy)
- temporal characteristics and risk factors of CIPN-related pain(2 years post Paclitaxel Chemotherapy)
- Use of Agents offered with an intend to prevent CIPN(2 years post Paclitaxel Chemotherapy)
研究者
parmanand jain
Professor, Anaesthesiology, Critical Care & Pain. Head, Division of Pain.
Tata Memorial Centre