A Randomized Clinical Trial Comparing Supplemental Topical Treatments for Acute Radiation Dermatitis in Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Acute Radiation Dermatitis
研究概览
简要总结
This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a radiation-induced skin reaction which can cause itching, swelling, pain, and general discomfort. Aquaphor is a commonly available, inexpensive, petrolatum-based multi-purpose ointment designed to protect and sooth extremely dry skin, chapped lips, cracked hands and feet, minor cuts and burns, and many other skin irritations. Miaderm is a water-based cream and contains ingredients like calendula, hyaluronate, and aloe vera which may help reduce occurrence and severity of radiation dermatitis. Both are commonly recommended and used by breast cancer patients undergoing external beam radiation therapy (EBRT). However, it is not known whether one is better than the other in treating or preventing radiation dermatitis.
详细描述
PRIMARY OBJECTIVE:
I. Determine the efficacy of Miaderm compared to Aquaphor in the treatment and/or prevention of radiation dermatitis caused by EBRT in breast cancer patients undergoing EBRT to the breast/chest wall.
SECONDARY OBJECTIVE:
I. Determine quality of life (QoL) and need for additional concomitant therapies to address dermatitis in breast cancer patients undergoing EBRT to the breast/chest wall using Miaderm compared to Aquaphor.
OUTLINE: Patients are randomized to 1 of 2 arms.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent of the participant and/or legally authorized representative.
- •Age > 18 years.
- •Undergoing external beam radiation therapy (EBRT) to the breast or chest wall following surgical resection (lumpectomy or mastectomy) for ductal carcinoma in situ (DCIS) or invasive breast cancer using either conventional fractionation or hypofractionation.
排除标准
- •Partial breast irradiation.
- •Prior radiation overlapping with the intended radiotherapy field.
- •History of systemic radiation sensitivity diseases (xeroderma pigmentosum, ataxia telangiectasia).
- •Extreme hypofractionation (less than 15 fractions of radiation).
- •Palliative treatment.
- •Patient intention to use topical product other than Aquaphor or Miaderm.
- •Inflammatory breast cancer, skin involvement, planned use of bolus.
研究组 & 干预措施
Arm I (Aquaphor)
Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
干预措施: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment (Other)
Arm I (Aquaphor)
Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
干预措施: Quality-of-Life Assessment (Other)
Arm I (Aquaphor)
Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
干预措施: Questionnaire Administration (Other)
Arm II (Miaderm)
Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
干预措施: Agent Affecting Integumentary System (Drug)
Arm II (Miaderm)
Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
干预措施: Quality-of-Life Assessment (Other)
Arm II (Miaderm)
Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Acute Radiation Dermatitis
时间窗: Up to 120 days after completion of radiation therapy
Depending on prescribed duration of radiation treatment, each subject will contribute between 5 and 8 periodic assessments for the presence of acute radiation dermatitis Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC toxicity score of 2 or higher). The hypothesized association between randomized treatment and the repeated binary outcome of Acute Radiation Dermatitis will be tested using repeated measures logistic regression. That model will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with generalized estimating equation (GEE) for binary data with logit link function. In this way, the analysis will recognize the within-patient correlation inherent in repeated assessments.
次要结局
- Quality of life (QoL)(Up to 120 days after completion of radiation therapy)
- Supportive measures(Up to 120 days after completion of radiation therapy)