A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Maximum skin toxicity
研究概览
简要总结
The purpose of this study is to determine whether Alkagin paste is effective at preventing radiodermatitis in patients receiving external beam radiation therapy to the perineal area.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving a dose of 45 Gy or more with concomitant chemotherapy to the perineal skin (for treatment of anal canal, low rectal or gynecological cancer).
- •Patients able to understand and sign an informed consent form.
- •Patients that do not have active connective tissue disorders.
- •Patients 18 years or older.
- •Patients that did not receive any previous radiation.
- •Patients that do not have any known allergy to any ingredients of the Alkagin Paste
- •Patients need to be able to apply the creams themselves or have help with applying the creams.
- •Patients who have been offered to purchase silver clear underpants but have refused
排除标准
- •Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it)
- •The Fitzpatrick Scale:
- •Type I (scores 0-7) White; very fair; freckles. Always burns, never tans
- •Type II (scores 8-16) White; fair. Usually burns, tans with difficulty
- •Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans
- •Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease
- •Type V (scores over 30) Dark brown. Very rarely burns, tans very easily
- •Type VI Black. Never burns, tans very easily
- •2) Patients with an allergic reaction to Alkagin Paste
研究组 & 干预措施
Arm B: standard of care plus Alkagin paste
Patients will apply Alkagin Paste to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. They will also perform standard of care skin treatment.
干预措施: Alkagin paste (Other)
Arm A: standard of care
Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatment
干预措施: Aveeno cream (Other)
Arm B: standard of care plus Alkagin paste
Patients will apply Alkagin Paste to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. They will also perform standard of care skin treatment.
干预措施: Aveeno cream (Other)
结局指标
主要结局
Maximum skin toxicity
时间窗: 7 weeks post beginning of radiation treatments
The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of Alkagin Paste compared to patients treated with institutional standard skin care.
次要结局
未报告次要终点
研究者
Dr. Te Vuong
MD-Director Radiation Oncology
Sir Mortimer B. Davis - Jewish General Hospital