A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- PPE grade
研究概览
简要总结
The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).
详细描述
This will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks.
The intervention group will receive the application of topical vitamin B6 cream to the hands and/or feet of the patients and the control group will receive the placebo.
At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult cancer patients (>18)
- •Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
- •Patients that will experience PPE grade 1 or above
- •Willing to participate
- •Ability to complete the psychometric assessments.
- •A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG
排除标准
- •Patients with hypersensitivity to Vitamin B.
- •Patients with pre-existing dermatological condition affecting the hands or/and feet that may limit the interpretation of results
- •Patients on oral Pyridoxine or nicotine patches
- •Patients with a previous history of PPE
- •Patients whose chemotherapy was discontinued for more than a week
结局指标
主要结局
PPE grade
时间窗: up to 4 weeks
The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials (Scheithauer et al 2003)
次要结局
- Quality of Life in relation to PPE(up to 4 weeks)
- Health Related Quality of Life(up to 4 weeks)
研究者
Dr. Andreas Charalambous
Assistant Professor
Cyprus University of Technology