Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading.
研究概览
简要总结
Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy plays an indispensable role in the course of breast cancer treatment, and the radiation dermatitis is the major side effect affected quality of life. Radiation dermatitis can be divided into acute and chronic. Severe acute radiation dermatitis affects the quality of life of patients during the course of treatment, and may cause treatment interruption and affect the efficacy. Chronic radiation dermatitis may cause irreversible skin problems, and lead to so-called "radiation-irritated skin" (radiation-irritated skin) seriously affects the quality of life of breast cancer patients after treatment.
This study will enroll 30 breast cancer patients who received whole breast radiation therapy after breast conserving surgery. Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up" effect.
Subjects will need to come back to clinics for assessment weekly during radiotherapy, 2 weeks after radiotherapy, and 6 weeks after radiotherapy. The evaluation includes physical examinations, questionnaire surveys, skin observation and measurements, and photographs. The total study time is at least 3 months. The target area of radiation-irritated skin condition will be observed and graded according to CTCAE rate. The skin physiological parameters will be detected by MoistureMeter SC, Vapometer, SkinColorCatch and HX-YL001 infrared thermometer.
Statistical analysis of skin physiological parameters is used to evaluate the efficacy of FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be males or non-pregnant females at least 20 years of age.
- •Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
- •Patients were scheduled to receive five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy or hypofraction irradiation fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy.
- •Participant must give informed consent.
排除标准
- •Bilateral breast cancer
- •Previous radiotherapy to the chest
- •Chemotherapy concurrent with radiation treatment
- •Prior breast reconstructions, implants, and/or expanders
- •Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
- •Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE)
- •Participation in any clinical trial in the prior 30 days from baseline.
- •Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
结局指标
主要结局
Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading.
时间窗: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later
Skin toxicity at the radiotherapy site will be assessed by investigator and NCI CTCAE v5.0 will be used for grading, on a scale of: Grade 1 (faint erythema or dry desquamation); Grade 2 (moderate to brisk erythema;patchy moist desquamation,mostly confined to skin foldsand creases; moderate edema); Grade 3 (moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion); Grade 4 (life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated); Grade 5 (death)
次要结局
- To compare the skin moisture percentage.(1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later)
- To compare the skin temperature of target region.(1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later)
- To compare the skin trans-epidermal water loss.(1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later)
- Median time to G2 radiation dermatitis development(1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later)
- The score of quality of life with the Skindex-16 questionnaire.(1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later)
研究者
Chih-Ying Liao
Attending physician
China Medical University Hospital