Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Acute Skin Toxicity Per NCI-CTC v4.0
研究概览
简要总结
This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.
详细描述
Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age 18 or older
- •Diagnosis of breast cancer
- •Intact breast (not surgically absent)
- •Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)
- •Ability to understand and comply with the requirements of this study
- •Ability to give Informed Consent
- •For sexually active females, patient agrees to use acceptable method of birth control
排除标准
- •Women who are pregnant or lactating
- •Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
- •Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
- •Severe renal failure creatinine > 3.0 within 6 months of study registration
- •Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
- •Planned relocation which would make follow-up visits impossible during the course of the study
- •Collagen vascular disease such as Lupus, or scleroderma
研究组 & 干预措施
HylaCare
HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment.
干预措施: HylaCare (Drug)
Placebo
The patient is her own control.
干预措施: Placebo (Drug)
结局指标
主要结局
Acute Skin Toxicity Per NCI-CTC v4.0
时间窗: Week 2 post-radiation therapy
NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Acute Skin Toxicity Per Investigator Grading Scale
时间窗: Week 2 post-radiation therapy
Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin 1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema 2. = erythema with dry desquamation 3. = wet desquamation \</= 2 cm 4. = wet desquamation from 2.1 - 5cm 5. = wet desquamation from 5.1 - 9 cm 6. = wet desquamation \> 9.1 cm
次要结局
- Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions(Week 5 during radiation therapy)
研究者
Asal Rahimi
Associate Professor of Medicine
University of Texas Southwestern Medical Center