StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of acute >grade 2 radiation dermatitis
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •At least 18 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Life expectancy of at least 6 months
- •Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
- •Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
- •No known allergy to studied products
- •Able to give written informed consent, or have written consent given on their behalf
- •Patients who are able and willing to attend the post-radiation weekly skin assessment appointments
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if preferred by patient. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
排除标准
- •Patients with gross cancer involvement of either or both inguinal regions.
- •Patients who have received prior pelvic and/or inguinal radiation therapy.
- •Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
- •Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
- •Patients with existing rashes or wounds in either inguinal region at baseline.
- •Planned inguinal dissection within 90 days after completion of radiation therapy on this study.
- •Female patients who are pregnant or breast feeding.
- •Patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.
结局指标
主要结局
Incidence of acute >grade 2 radiation dermatitis
时间窗: Until 8 weeks post radiation therapy; up to 4 months
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions. The amount of \> grade 2 RD cases will be compared in both study groups.
次要结局
- Itchiness score(Until 8 weeks post radiation therapy; up to 4 months)
- Average toxicity assessed using the CTCAE(Until 8 weeks post radiation therapy; up to 4 months)
- Time to onset of moist desquamation(Until 8 weeks post radiation therapy; up to 4 months)
- Pain scores(Until 8 weeks post radiation therapy; up to 4 months)