Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 30
- 主要终点
- Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2
研究概览
简要总结
RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women receiving doxorubicin hydrochloride liposome for metastatic breast cancer.
PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients receiving doxorubicin hydrochloride liposome for metastatic breast cancer.
详细描述
OBJECTIVES:
- Evaluate the effects of F511 cream on the occurrence of palmar-plantar erythrodysesthesia (PPE) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin hydrochloride.
OUTLINE: This is a multicenter study.
Patients receive pegylated liposomal doxorubicin hydrochloride according to local practice on 1, 2, or 4 weeks course schedules with at least 10 mg/m^2 per week allowed.
Patients apply F511 cream on one side, hand and foot and the corresponding placebo on the other side hand and foot once daily (the morning) during the first week of the first pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times per week thereafter. Treatment continues throughout chemotherapy administration in the absence of palmar-plantar erythrodysesthesia (PPE) ≥ grade 2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of metastatic breast cancer
- •No cutaneous metastases on hands or feet
- •Pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to the local investigator
- •Planned dose at least 10 mg/m^2 per week
- •No sign of palmar-plantar erythrodysesthesia (PPE) at study entry
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Able to apply topical medication (cream) or provide for another person to apply cream
- •Not pregnant or breastfeeding
- •Fertile patients must use effective contraception during trial participation and for 1 month after completion
- •Negative pregnancy test
- •Compliant and geographically proximal in order to allow proper evaluation and follow-up
- •No dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
- •No known allergy or hypersensitivity to F511 cream
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 30 days since prior and no concurrent treatment with other experimental drugs or anticancer therapy
- •More than 30 days since prior and no concurrent treatment on another clinical trial
- •No concurrent local use of other ointments or creams for hands or feet other than Excipial Repair®
排除标准
- 未提供
结局指标
主要结局
Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2
时间窗: Until PPE grade ≥2
次要结局
- Extent of symptom relief(Until PPE grade ≥2)
- Recurrence of PPE grade ≥ 2(Until PPE grade ≥2)
- Adverse skin reaction to local therapy(Until PPE grade ≥2)
- Patient-reported outcome(Until PPE grade ≥2)