Effectiveness of Prophylactic Topical Treatments for Radiation Dermatitis

预防性局部治疗放射性皮炎的有效性

• 批准号: 8930084
• 负责人: Julie Ryan Wolf
• 金额: $ 16.69万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8930084
• 关键词: Acute; Anti Inflammatory Analgesics; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Aquaphor; Atopic Dermatitis; Blinded; Breast Cancer Patient; Burn injury; Cancer Center; Cancer Control; Cancer Patient; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Cream; Curcumin; Dermatology; Drug Formulations; Effectiveness; Enrollment; Evaluation; Feedback; Free Radicals; Gel; Goals; Healed; Health; Hydrocortisone; Inflammation; Inflammatory Response; Injury; Intervention; Lidocaine; Measures; Mus; Oral; Pain; Participant; Patient Self-Report; Patients; Phase; Phase II/III Trial; Placebo Control; Placebos; Play; Powder dose form; Prevention strategy; Preventive; Property; Pruritus; Psoriasis; Radiation; Radiation Oncology; Radiation therapy; Radiodermatitis; Randomized; Reaction; Research; Research Proposals; Role; Severities; Skin; Symptoms; Testing; Therapeutic; Topical agent; Topical application; Toxic effect; Tumeric; Universities; Water; arm; base; cancer radiation therapy; cancer therapy; capsule; clinical care; clinically significant; comparative efficacy; compare effectiveness; diaries; efficacy trial; experience; healing; hyaluronate; improved; innovation; multidisciplinary; oncology; palmidrol; pilot trial; placebo controlled study; preclinical study; prevent; prophylactic; standard care; standard of care; treatment site; treatment strategy

DESCRIPTION (provided by applicant): No proven treatments exist to prevent the radiation-induced skin reactions that are experienced by 95% of cancer patients receiving radiation therapy. Current standard care for radiation dermatitis involves topical products that are prescribed once radiation-induced skin reactions occur, despite the lack of evidence to support the benefit of any such treatments. Although research suggests that topical agents with anti-inflammatory and moisturizing properties may prevent and/or reduce radiation-induced skin reactions, few studies have tested and/or compared the prophylactic effects of topical treatments. For example, both preclinical and clinical studies have shown that increased transepidermal water loss (TEWL) correlates with increased severity of radiation dermatitis. We hypothesize that moisturizing topical interventions with anti-inflammatory properties could reduce radiation dermatitis severity by minimizing TEWL and inflammation during radiation therapy. We propose to conduct a randomized, three-armed, placebo-controlled, blinded clinical pilot trial (N=150) to compare the prophylactic effects of two investigational topical agents, MimyX(R) (0.3% PEA) and Curcumin (4%) gel, versus placebo gel added to the University of Rochester Cancer Center "standard care" on the severity of radiation dermatitis and associated pain. The innovative design of this clinical trial will provide results that show either current "standard care" is the best treatment option or that prophylactic use of another topical intervention is the best option., Additionally, results will determine if a "preventive" approach (i.e., before onset of skin reaction) to clinical care of radiation dermatitis is superior to a "treatment" approach (i.e., after onset of skin reaction). This research proposal incorporates a unique, multidisciplinary team with expertise in the fields of dermatology, radiation oncology, and cancer control. Ultimately, the goal of this study is to identify one or two topical agents for further evaluation in a phase II/III efficacy trial for preventing and/or reducing RT-induced skin reactions and associated pain. Findings from this trial could advance the approach to clinical management of radiation dermatitis, an extremely common toxicity encountered by the majority of patients receiving radiation therapy for cancer.

描述（由申请人提供）：目前尚无行之有效的治疗方法可以预防 95% 接受放射治疗的癌症患者所经历的放射引起的皮肤反应。目前放射性皮炎的标准护理涉及一旦发生辐射引起的皮肤反应就开出的局部产品，尽管缺乏证据支持任何此类治疗的益处。尽管研究表明具有抗炎和保湿特性的外用药物可以预防和/或减少辐射引起的皮肤反应，但很少有研究测试和/或比较外用治疗的预防效果。例如，临床前和临床研究均表明，经表皮失水 (TEWL) 的增加与放射性皮炎严重程度的增加相关。我们假设具有抗炎特性的保湿局部干预措施可以通过最大限度地减少放射治疗期间的 TEWL 和炎症来降低放射性皮炎的严重程度。我们建议进行一项随机、三臂、安慰剂对照、盲法临床试点试验 (N=150)，以比较两种研究性外用药物 MimyX(R) (0.3% PEA) 和姜黄素 (4%) 凝胶与罗切斯特大学癌症中心“标准护理”中添加的安慰剂凝胶对放射性皮炎和相关疼痛严重程度的预防效果。该临床试验的创新设计将提供结果，表明当前的“标准护理”是最佳治疗选择，或者预防性使用另一种局部干预措施是最佳选择。此外，结果将确定放射性皮炎临床护理的“预防”方法（即，在皮肤反应发生之前）是否优于“治疗”方法（即，在皮肤反应发生后）。该研究计划由一个独特的多学科团队组成，他们在皮肤病学、放射肿瘤学和癌症控制领域拥有专业知识。最终，本研究的目标是确定一种或两种局部用药 在预防和/或减少放疗引起的皮肤反应和相关疼痛的 II/III 期疗效试验中进行进一步评估。这项试验的结果可能会推进放射性皮炎的临床治疗方法，这是大多数接受癌症放射治疗的患者遇到的一种极其常见的毒性。