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: 8749597
• 负责人: Julie Ryan Wolf
• 金额: $ 20.03万
• 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 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8749597
• 关键词: Acute; Anti Inflammatory Analgesics; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Aquaphor; Atopic Dermatitis; Blinded; Burn injury; Cancer Center; Cancer Control; Cancer Patient; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Cream; Curcumin; Dermatitis; Dermatology; Drug Formulations; Effectiveness; Enrollment; Evaluation; Feedback; Free Radicals; Gel; Goals; Healed; 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; 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; malignant breast neoplasm; multidisciplinary; oncology; palmidrol; pilot trial; placebo controlled study; preclinical study; prevent; prophylactic; public health relevance; 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）：没有经过证实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诱导的皮肤反应。目前放射性皮炎的标准护理涉及一旦发生辐射诱导的皮肤反应就处方的局部产品，尽管缺乏证据支持任何此类治疗的益处。虽然研究表明，具有抗炎和保湿特性的局部药物可以预防和/或减少辐射引起的皮肤反应，但很少有研究测试和/或比较局部治疗的预防作用。例如，临床前和临床研究都表明，增加的经表皮水分损失（TEWL）与放射性皮炎的严重程度增加相关。我们假设，具有抗炎特性的保湿局部干预可以通过最大限度地减少TEWL和放射治疗期间的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、三组、安慰剂对照、盲法临床试验（N=150），以比较两种研究性局部药物MimyX（R）（0.3% PEA）和姜黄素（4%）凝胶与安慰剂凝胶对放射性皮炎和相关疼痛严重程度的预防作用，这些药物添加到罗切斯特大学癌症中心的“标准治疗”中。这项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是最佳选择。此外，结果将决定是否采取“预防性”方法（即，在皮肤反应发生之前）对放射性皮炎的临床护理上级“治疗”方法（即，在皮肤反应开始后）。这项研究计划包括一个独特的，多学科的团队，在皮肤病学，放射肿瘤学和癌症控制领域的专业知识。最终，本研究的目标是确定一种或两种局部药物， 在II/III期疗效试验中进一步评估预防和/或减少RT诱导的皮肤反应和相关疼痛。这项试验的结果可以推进放射性皮炎的临床管理方法，这是大多数接受癌症放射治疗的患者遇到的一种非常常见的毒性。