A Paired Double Blind Randomised Comparison of Cavilon(TM) Durable Barrier Cream(TM)[CDBC] to 10% Glycerine ("Sorbolene") Cream in the Prophylactic Management of Post-Mastectomy Irradiation Skin Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 333
- 试验地点
- 12
- 主要终点
- Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
研究概览
简要总结
This study has patients using two different moisturising creams during radiation therapy after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may be reduced by the Cavilon cream compared to sorbolene.
详细描述
Skin reactions are a common and undesirable result of radiation treatment. Preventative measures are often used although there are few controlled trials. Commonly employed agents for established reactions have included sorbolene (10% Glycerine), silver sulphadiazine, hydrocolloid dressings, topical steroids, salt water or bicarbonate of soda water solution bathing and hydrogen peroxide. One trial found that Cavilon No-Sting Barrier film reduced Grade 3 skin reaction compared to sorbolene, although this film did not contain any moisturising agents.
General Hypothesis: That in a paired double blind randomised study peak and overall skin reactions experienced by post mastectomy breast cancer patients receiving radiotherapy may be reduced by Cavilon Durable Barrier Cream (CDBC) compared to Sorbolene.
Alternative Hypothesis of primary outcome: the frequency of grade 3 or more skin reaction will be reduced from 35% to 25% for skin care using sorbolene or CDBC respectively.
Alternative Hypothesis of secondary outcome: the mean area under the curve (AUC) of total skin reaction will be reduced from 9 to 8 for skin care using sorbolene or CDBC respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Ages 18 or more years
- •Post total mastectomy
- •Planned dose at least 45 Gy in 25 fractions
- •Able to attend weekly during treatment for review and photo and for up to 6 weeks after radiotherapy
- •Patients capable of childbearing using adequate contraception
- •Written informed consent
排除标准
- •Previous radiotherapy to the chest wall to be treated
- •Macroscopic cutaneous involvement by malignancy at time of radiotherapy
- •Known allergy to product contents
- •Patients who are pregnant or lactating.
研究组 & 干预措施
1
干预措施: Cavilon (TM) Durable Barrier Cream (Drug)
1
干预措施: Sorbolene (Drug)
1
干预措施: Radiotherapy (Radiation)
2
干预措施: Cavilon (TM) Durable Barrier Cream (Drug)
2
干预措施: Sorbolene (Drug)
2
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
时间窗: 12 weeks
次要结局
- Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks(12 weeks)