A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This phase I trial studies the side effects of a silicone topical wound dressing (StrataXRT) and to see how well it works in preventing radiation dermatitis (skin burns and side effects caused by radiation) in pediatric patients undergoing radiation therapy. StrataXRT may help prevent or decrease severe skin rash, pain, itching, skin peeling, and dry skin in pediatric patients undergoing radiation therapy to the brain or spinal cord.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the safety (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) of StrataXRT and placebo by assessing gel-associated toxicities among pediatric patients, aged 2-17 undergoing proton cerebrospinal irradiation (CSI) for central nervous system (CNS) tumors.
II. To estimate the efficacy of StrataXRT as a preventative agent for radiation-associated dermatitis among pediatric patients, aged 2-17 undergoing proton CSI for CNS tumors.
SECONDARY OBJECTIVES:
I. To explore the relationship between dosing and the efficacy of StrataXRT. II. To explore the relationship between the use of StrataXRT and parent-reported symptom experience, as measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients between the ages of 2 years old and 17 years old
- •Patients diagnosed with primary CNS tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton CSI
- •Patients planned to receive at least 20 Gy CSI at 1.8 - 2.0 Gy per fraction
- •Patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the StrataXRT and placebo twice a day for the duration of the study and complete the study instruments
- •Informed consent by parents or legal guardian; consent documents will be translated with non-English speaking participants
排除标准
- •Patients who have already started proton CSI treatment
- •Patients receiving > 10 fractions photon therapy
- •Patients with pre-existing dermal scarring, as determined by a clinical member of the study staff
- •Patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18)
- •Patients planned to receive less than 20 Gy CSI at 1.8-2.0 Gy per fraction
研究组 & 干预措施
Supportive care (StrataXRT, placebo)
Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear BID until the last day of radiation therapy.
干预措施: Placebo Administration (Other)
Supportive care (StrataXRT, placebo)
Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear BID until the last day of radiation therapy.
干预措施: Questionnaire Administration (Other)
Supportive care (StrataXRT, placebo)
Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear BID until the last day of radiation therapy.
干预措施: Wound Dressing Material (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 6 weeks
Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will be calculated for each control and experimental forehead and ears.
StrataXRT as a preventative agent for radiation-associated dermatitis
时间窗: Up to 6 weeks
To estimate the efficacy of StrataXRT among pediatric patients.
次要结局
- Dosing of StrataXRT(Up to 6 weeks)
- Parent-reported symptom experience(Up to 6 weeks)
- Compliance(Up to 6 weeks)