Exploring paclitaxel inducednail changes in patients receiving weekly paclitaxel - A Clinical observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- 1.Demographic characteristics, clinical presentations, histopathology reports, diagnostic results, and treatment details.
研究概览
简要总结
Newly diagnosed breast cancer patients and who will be assigned for paclitaxel based chemotherapy as a normal care will be approached for the participation in this study. Chemotherapeutic drugs induced nail alterations. However, during the course of treatment, nail changes can transform from tolerable morphological and structural changes into painful lesions that can impair several functionalities. The mechanism by which chemotherapeutic agents affect nails is not well understood or well-studied. In this study, we represent a clinical observation on the nail changes in patients receiving weekly paclitaxel.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years.
- •Female patients Diagnosed with histologically verified, all malignancy breast and ovarian cancers for the first time.
- •Planned for AC-Taxol protocol on weekly (Adriamycin and cyclophosphamide, followed by treatment with paclitaxel).
排除标准
- •Any patients with previous dermatological or systematic disorders which affect nails.
- •Serious nail changes that need interventional management such as acute paronychia and Onycholysis.
结局指标
主要结局
1.Demographic characteristics, clinical presentations, histopathology reports, diagnostic results, and treatment details.
时间窗: 0 weeks - baseline, 9th week and last chemotherapy
2.Evaluate the nails by using National Cancer Institute criteria (Common Terminology Criteria for Adverse Events, Version 4.0) by clinical examination.
时间窗: 0 weeks - baseline, 9th week and last chemotherapy
次要结局
未报告次要终点
研究者
Dr Ananth Pai
Kasturba Medical College and Hospital