Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation:A Randomized Trial, Double Blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 11
- 主要终点
- Percentage of Participants With Moist Desquamation
研究概览
简要总结
The purpose of this study is to find out if the effect of mometasone furoate is any different from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing the skin from peeling, or reducing the amount of irritation the patient reports during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age ≥18 years
- •Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC
- •Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT
- •ECOG Performance Status of 0 or 1
排除标准
- •Patients with clinical evidence of gross disease
- •Patients who are pregnant or breastfeeding
- •Prior radiation therapy to the ipsilateral chest wall or thorax
- •Patients requiring a chest wall boost
- •Concurrent chemotherapy (biologic agents are allowed)
- •Psychiatric illness that would prevent the patient from giving informed consent
- •Inability or unwillingness to comply with skin care instructions and follow-up
- •Allergy to either Eucerin or MF
- •Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT
- •Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)
- •Treatment with palliative or pre-operative radiation
研究组 & 干预措施
Mometasone Furoate 0.1%
Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Patients should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.
干预措施: Mometasone Furoate 0.1% (Other)
Eucerin
Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.
干预措施: Eucerin (Other)
结局指标
主要结局
Percentage of Participants With Moist Desquamation
时间窗: 2 years
Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice.
次要结局
- Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment(5 weeks and Baseline)
- Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up(2 weeks after end of Radiation Therapy)