Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
研究概览
简要总结
RATIONALE: Nicotine patches may reduce hand-foot syndrome in patients receiving capecitabine for metastatic breast cancer. It is not yet known which nicotine patch regimen may be more effective in reducing hand-foot syndrome.
PURPOSE: This randomized clinical trial is studying which schedule of using nicotine patches is more effective in reducing hand-foot syndrome in patients who are receiving capecitabine for metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of using nicotine patches, in terms of side effects and the number of voluntary withdrawals from the study, in patients with metastatic breast cancer undergoing chemotherapy with capecitabine.
Secondary
- Determine the efficacy of nicotine patches as preventive agents for hand-foot syndrome (HFS) by assessing the incidence of HFS in each arm.
- Determine the grade of HFS in each arm.
- Determine the percentage of patients requiring a reduction in dose of capecitabine due to adverse events.
- Determine the percentage of patients requiring pain medication for HFS.
- Determine the percentage of patients using other symptomatic treatments for HFS (e.g., moisturizers, ice, cooling packs).
- Evaluate the effect of nicotine patches on quality-of-life of patients undergoing capecitabine chemotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: Prior to initiation of capecitabine
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
干预措施: Nicotine patch (Drug)
Arm B: After hand-foot syndrome symptoms appear
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
时间窗: up to 24 weeks
Incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 for all patients assigned who received at least 1 cycle of capecitabine.
次要结局
- Number of Patients With Reported Use of Pain Medication for HFS(Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year)
- Quality of Life as Measured by FACT-B Scale(Up to 15 weeks)
- Frequency of Side Effects of the Transdermal Nicotine Patch(Up to 15 weeks)
- Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary(up to 15 weeks)
- Number of Patients Requiring Dose Reduction of Capecitabine(up to 24 weeks)
- Number of Patients With Reported Use of Other Symptomatic Treatments for HFS(Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year)