A Comparative Study Between Topical Betamethasone Cream or Topical Olive Oil Cream in Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Acute Radiation Dermatitis (ARD) grading
研究概览
简要总结
This study aims to compare the prophylactic effect of topical betamethasone valerate cream and topical olive oil cream in the prevention of acute radiation dermatitis (ARD) in breast cancer patients treated with radiation. Betamethasone valerate, olive oil cream and the base cream will be compared in a randomized trial to evaluate and compare the development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score, percentage of patients with the maximum observed ARD grade for each arm of the study, percentage of patients with moist desquamation for each arm of the study, percentage of radiodermatitis-free patients at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy). In addition, the patients' quality of life will be evaluated using Dermatology Life Quality Index (DLQI).
详细描述
Aim of the study:
- This study will be conducted to compare the efficacy of topical steroid cream and topical olive oil cream instituted from the start of radiotherapy in the prevention of acute radiation dermatitis in breast cancer patients.
Objectives:
- To compare the prophylactic effect of topical betamethasone valerate cream and topical olive oil cream in the prevention of acute radiation dermatitis in breast cancer patients.
- To provide prospective data evaluating the quality of life (QoL), as most data on QoL in breast cancer patients are derived from cross-sectional studies.
Methodology:
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
- Double (Participant, Care Provider)
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
- •Histological confirmation of breast malignancy,
- •Surgical intervention for carcinoma of the breast with or without lymph node metastasis.
- •Treatment with planned course of radiation therapy 5 days a week for 3-6 weeks.
- •Good Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1).
- •Total radiation dose of ≥42 Gy.
排除标准
- •Pregnant and lactating mothers.
- •Previous radiation to the chest or breast area.
- •Concomitant chemotherapy.
- •Concomitant medication that may cause skin reactions.
- •Use of any other product on the skin at the treatment site at any time of the study.
- •Active dermatitis, history of autoimmune and connective tissue diseases, skin inflammatory diseases or any other specific skin disease.
- •Treatment with local or oral corticosteroid, or antioxidant medications.
- •Allergy to olive oil.
- •Inflammatory carcinoma of the breast as well as those with a known allergy to olive oil.
研究组 & 干预措施
Betamethasone cream
Patients will apply Betamethasone Valerate 0.1% cream to the irradiated area twice a day.
干预措施: Betamethasone Valerate Cream (Drug)
Olive oil cream
Patients will apply prepared Olive Oil cream to the irradiated area twice a day.
干预措施: Olive oil cream (Drug)
Base cream
Patients will apply prepared base cream to the irradiated area twice a day.
干预措施: Base Cream (Other)
结局指标
主要结局
Acute Radiation Dermatitis (ARD) grading
时间窗: T1=7 days after beginning treatment +/- 3 days; to T8=56 days after beginning treatment+/- 3 days}.
• Development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score
次要结局
- Quality of Life questionnaire({T1=7 days after beginning treatment +/- 3 days to T8=56 days after beginning treatment+/- 3 days} .)
- Patient Satisfaction(Two weeks post the last dose of radiation therapy)
研究者
Samar Farghali Farid
Professor, Head of Clinical Pharmacy Department
Cairo University