Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity
研究概览
简要总结
This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.
详细描述
PRIMARY OBJECTIVES:
I. To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study.
SECONDARY OBJECTIVES:
I. To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ [DCIS])
- •Status post-lumpectomy, -quadrantectomy, or -mastectomy
- •Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
- •Total dose >= 40Gy
- •Dose per fraction >= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
- •Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
- •Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist
- •Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
- •Patients who are able and willing to sign protocol consent form
排除标准
- •Prior radiation to the involved breast or chest wall
- •Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
- •Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
- •Patients undergoing partial breast irradiation
- •Patients who have undergone MammoSite® or any other form of brachytherapy
- •Patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
Supportive Care (KeraStat Skin Therapy)
Patients apply KeraStat Skin Therapy topically BID during radiation therapy.
干预措施: dermatologic complications management/prevention (Procedure)
Supportive Care (KeraStat Skin Therapy)
Patients apply KeraStat Skin Therapy topically BID during radiation therapy.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity
时间窗: Up to 2 months after completion of radiation therapy
At each time point the proportion of women who have RT-induced EASR present will be estimated and a 95% confidence interval will be calculated around this estimate.
次要结局
未报告次要终点