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测试 Mepitel 胶片在放射治疗期间的应用，以减少乳房切除术后乳腺癌患者的辐射相关发红和脱皮

2026年8月27日 更新者：Alliance for Clinical Trials in Oncology

美皮贴减少接受乳房切除术后放射治疗的乳腺癌患者的放射性皮炎：一项随机 III 期临床试验

This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care.

KEY SECONDARY OBJECTIVES:

I. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a centralized, blinded provider assessment review of photographs.

II. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a non-blinded institutional provider assessment.

III. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a combined patient and non-blinded institutional provider assessment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care skin management during radiation therapy for up to 6 weeks.

ARM II: Patients receive Mepitel Film applied to breast or chest wall as needed or once every 2 weeks before radiation therapy for up to 6 weeks.

After completion of study, patients are followed up at 7-14 days, 3 months, 6 months, 1 year, 2 years, then every 6 months up to 5 years.

研究类型

介入性

注册 (实际的)

216

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Marysville、California、美国、95901
        • Fremont - Rideout Cancer Center
      • Truckee、California、美国、96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Delaware
      • Frankford、Delaware、美国、19945
        • Beebe South Coastal Health Campus
      • Newark、Delaware、美国、19713
        • Helen F Graham Cancer Center
      • Newark、Delaware、美国、19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach、Delaware、美国、19971
        • Beebe Health Campus
    • Florida
      • Atlantis、Florida、美国、33462
        • John Fitzgerald Kennedy Medical Center
    • Iowa
      • Ames、Iowa、美国、50010
        • McFarland Clinic - Ames
      • Cedar Rapids、Iowa、美国、52403
        • Mercy Hospital
      • Cedar Rapids、Iowa、美国、52403
        • Oncology Associates at Mercy Medical Center
      • Clive、Iowa、美国、50325
        • Mercy Cancer Center-West Lakes
      • Des Moines、Iowa、美国、50309
        • Iowa Methodist Medical Center
      • Des Moines、Iowa、美国、50314
        • Mercy Medical Center - Des Moines
      • Des Moines、Iowa、美国、50309
        • Medical Oncology and Hematology Associates-Des Moines
    • Maine
      • Bath、Maine、美国、04530
        • MaineHealth Coastal Cancer Treatment Center
      • Portland、Maine、美国、04102
        • Maine Medical Center-Bramhall Campus
      • Sanford、Maine、美国、04073
        • MaineHealth Cancer Care Center of York County
      • Scarborough、Maine、美国、04074
        • Maine Medical Center- Scarborough Campus
    • Maryland
      • Annapolis、Maryland、美国、21401
        • Anne Arundel Medical Center
      • Baltimore、Maryland、美国、21215
        • Sinai Hospital of Baltimore
      • Baltimore、Maryland、美国、21201
        • University of Maryland/Greenebaum Cancer Center
      • Columbia、Maryland、美国、21044
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie、Maryland、美国、21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
      • Towson、Maryland、美国、21204
        • UM Saint Joseph Medical Center
    • Michigan
      • Ann Arbor、Michigan、美国、48106
        • Saint Joseph Mercy Hospital
      • Brighton、Michigan、美国、48114
        • Saint Joseph Mercy Brighton
      • Livonia、Michigan、美国、48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic in Rochester
    • Missouri
      • Rolla、Missouri、美国、65401
        • Delbert Day Cancer Institute at PCRMC
      • Springfield、Missouri、美国、65804
        • Mercy Hospital Springfield
      • St Louis、Missouri、美国、63141
        • Mercy Hospital Saint Louis
    • Montana
      • Billings、Montana、美国、59101
        • Billings Clinic Cancer Center
    • New York
      • Glens Falls、New York、美国、12801
        • Glens Falls Hospital
      • White Plains、New York、美国、10601
        • Dickstein Cancer Treatment Center
    • North Dakota
      • Grand Forks、North Dakota、美国、58201
        • Altru Cancer Center
    • Pennsylvania
      • Meadowbrook、Pennsylvania、美国、19046
        • Holy Redeemer Hospital and Medical Center
    • South Carolina
      • Anderson、South Carolina、美国、29621
        • AnMed Health Cancer Center
      • Georgetown、South Carolina、美国、29440
        • Tidelands Georgetown Memorial Hospital
      • Greenville、South Carolina、美国、29607
        • Saint Francis Cancer Center
      • Greenville、South Carolina、美国、29601
        • Saint Francis Hospital
      • Greer、South Carolina、美国、29651
        • Gibbs Cancer Center-Pelham
      • Murrells Inlet、South Carolina、美国、29576
        • MUSC Health Tidelands Health Radiation Therapy Center
      • Spartanburg、South Carolina、美国、29303
        • Spartanburg Medical Center
    • Texas
      • Laredo、Texas、美国、78041
        • Doctor's Hospital of Laredo
    • Utah
      • Salt Lake City、Utah、美国、84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City、Utah、美国、84106
        • University of Utah Sugarhouse Health Center
    • Wisconsin
      • Appleton、Wisconsin、美国、54911
        • ThedaCare Regional Cancer Center
      • Wausau、Wisconsin、美国、54401
        • Aspirus Regional Cancer Center
      • Wisconsin Rapids、Wisconsin、美国、54494
        • Aspirus Cancer Care - Wisconsin Rapids

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Histologic confirmation of breast malignancy with TNM staging.
  • Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy.
  • No prior radiotherapy to any portion of the planned treatment site.
  • No documented history of adhesive or tape allergy.
  • Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible.
  • No active rash or pre-existing dermatitis within the treatment field.
  • No co-existing medical conditions resulting in life expectancy < 2 years.
  • No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis).
  • No concomitant cytotoxic chemotherapy. Endocrine therapy and HER2 directed therapies are allowed.
  • No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy.
  • No previous history of organ or bone marrow transplant.
  • Age >= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and read English.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Arm I (standard of care)

Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
其他：Quality-of-Life Assessment

Ancillary studies

其他：Questionnaire Administration

Ancillary studies

其他：Best Practice

Receive standard of care

其他名称：
  • 护理标准
实验性的：Arm II (Mepitel Film)

Patients receive Mepitel Film applied to breast or chest wall every 2 weeks before radiation therapy for up to 6 weeks.
其他：Quality-of-Life Assessment

Ancillary studies

其他：Questionnaire Administration

Ancillary studies

设备：Wound Dressing Material

Apply Mepitel Film

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
大体时间：Up to 5 months

Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a patient-completed mRISRAS score ranges from 0 to 12, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Up to 5 months

次要结果测量

结果测量
措施说明
大体时间
Centralized, Blinded Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores Obtained From a Blinded Grading of the Photographs Taken at the End of Radiation Therapy
大体时间：Up to 2 months

At the completion of radiation therapy, photographs will be obtained one hour after the removal of the Mepitel Film or immediately following completion of radiation therapy for patients on the standard of care arm. A panel of radiation oncology providers will perform the blinded, central review to score the photographs. Each provider will independently assign a provider-completed mRISRAS score to each photograph, and the average score will be calculated for each patient. The provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The Wilcoxon rank-sum test will be used to test for an effect of the Mepitel Film.
Up to 2 months
Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
大体时间：Up to 5 months

Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Up to 5 months
Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
大体时间：Up to 5 months

Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 36, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Up to 5 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Kimberly Corbin, MD、Mayo Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年7月26日

初级完成 (实际的)

2024年5月29日

研究完成 (估计的)

2029年2月15日

研究注册日期

首次提交

2021年7月26日

首先提交符合 QC 标准的

2021年7月26日

首次发布 (实际的)

2021年8月4日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • A221803
  • UG1CA189823 (美国 NIH 拨款/合同)
  • NCI-2019-04688 (注册表标识符：NCI Clinical Trial Reporting Program)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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