An Open-Label, Randomized Study to Evaluate the Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis In Breast Cancer Patients Undergoing Radiation Therapy.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of patients using HO/02/02 20µg that developed grade 1-4 radiation dermatitis during adjuvant radiation therapy for breast cancer compared to SoC (Aloe Vera) commonly used as standard of care treatment.
研究概览
简要总结
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment
详细描述
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment in addition to sterile water for irrigation applied daily for 15 minutes (with gauze) on treatment fields to create the same cooling effect as in treatment arm 1. Both treatment arms 1&2 treatments will be applied topically once daily for up to 8 weeks to reduce radiation dermatitis in up to 90 breast cancer patients undergoing adjuvant radiation therapy.
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
- 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
- •Female patients 18 years old and above.
- •Histology confirmed unilateral breast cancer following lumpectomy
- •Planned to receive 50 Gy, whole breast XRT and regional lymph nodes radiation.
- •ECOG performance status 0-2
- •Completed Chemotherapy 3 weeks prior to XRT (if applicable)
- •Patient should be available for the entire study period, and be able and willing to adhere to protocol requirements;
- •Patient must sign an informed consent form prior to undergoing any study-related procedures
排除标准
- •Known uncontrolled diabetes
- •Prior radiation to breast
- •Known connective tissue disorder
- •Known skin disease over the treated breast
- •Prior burn over treated area
- •Evidence of infection or inflammation of breast to be treated.
- •Receiving biological therapy or hormone therapy (other than Herceptin) during radiation treatment/study duration and 4 weeks prior to study entry.
- •Pre-existing skin breakdown within the planned radiotherapy field at the time of study entry.
- •Pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the Investigator.
- •Participation in another investigational drug or vaccine trial concurrently or within 30 days.
- •Use of any other topical or systemic treatments aimed at radiation dermatitis.
- •Use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation
研究组 & 干预措施
HO/02/02
Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily
干预措施: HO/02/02 20µg (Drug)
Aloe Vera Jel
To be applied topically
干预措施: Aloe Vera Jel (Other)
结局指标
主要结局
Number of patients using HO/02/02 20µg that developed grade 1-4 radiation dermatitis during adjuvant radiation therapy for breast cancer compared to SoC (Aloe Vera) commonly used as standard of care treatment.
时间窗: 62 days
次要结局
- Frequency and severity of adverse events reported by the patients and assessed clinically by NCI CTC v2.0(62 Days)