Topical corticosteroid in prevention of radiation dermatitis in breast cancer patients undergoing breast conservative treatment - an intrapatient randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To determine the incidence and time to onset of grade 2 or more radiation dermatitis using CTCAE v5.0 criteria and score 3 or more pain score as assessed by the visual analogue scale (VAS)
研究概览
简要总结
Title of the project is "Topical corticosteroid in prevention of radiation dermatitis in breast cancer patients undergoing breast conservative treatment - an intrapatient randomized controlled trial".
Among breast cancer patients receiving radiation, a wide majority of them(74-100%) report radiation dermatitis. Radiation dermatitis has major consequences on adherence to treatment and quality of life. Though there are many methods for prevention of radiation dermatitis there is no standard treatment as such. One of the method is using topical corticosteroids. They are prescribed because of their ability to counteract the cytokine release caused by radiation.They also induce vasoconstriction,decrease capillary permeability & inhibit leukocyte proliferation and migration. Mometasone furoate is well tolerated with only transient, mild to moderate local adverse effects. The result in this study will provide clarity and efficacy on using Mometasone furoate steroid cream in reducing radiation dermatitis and local site pain in early breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Above 18 years of age 2.Breast-conservative surgery for breast cancer 3.A hypofractionation regimen of 40.5Gy in 15 fractions (fx) with simultaneous integrated boost technique.
排除标准
- •1.Hypersensitivity to mometasone furoate 2.Bilateral breast carcinoma 3.Patients receiving leukotriene inhibitors 4.Patients on steroids for chronic conditions 5.Active dermatitis 6.Any preexisting dermatological disorder 7.Tattoos in the irradiation area 8.Previous radiation to ipsilateral breast 9.Metastatic disease 10.Active smoking status 11.Pre-existing skin breakdown within the planned radiotherapy field at the time of study.
结局指标
主要结局
To determine the incidence and time to onset of grade 2 or more radiation dermatitis using CTCAE v5.0 criteria and score 3 or more pain score as assessed by the visual analogue scale (VAS)
时间窗: weekly,at the last fraction of radiation and 4 weeks post radiation
次要结局
- To assess skin toxicity on quality of life as measured by Radiation Induced Skin Reactions Assessment score(RISRAS) and Dermatology life quality index questionnaire (DLQI)(weekly,at the last fraction of radiation and 4 weeks post radiation)
研究者
Dr Adapa Bindu Sai Sree
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH