유방 절제술 후 유방암 환자의 방사선 관련 발적 및 벗겨짐을 줄이기 위해 방사선 요법 중 Mepitel 필름 적용 테스트
유방 절제술 후 방사선 치료를 받는 유방암 환자의 방사선 피부염 감소를 위한 메피텔 필름: 무작위 3상 임상 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
-
-
California
-
Marysville, California, 미국, 95901
- Fremont - Rideout Cancer Center
-
Truckee, California, 미국, 96161
- Gene Upshaw Memorial Tahoe Forest Cancer Center
-
-
Delaware
-
Frankford, Delaware, 미국, 19945
- Beebe South Coastal Health Campus
-
Newark, Delaware, 미국, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, 미국, 19713
- Medical Oncology Hematology Consultants PA
-
Rehoboth Beach, Delaware, 미국, 19971
- Beebe Health Campus
-
-
Florida
-
Atlantis, Florida, 미국, 33462
- John Fitzgerald Kennedy Medical Center
-
-
Iowa
-
Ames, Iowa, 미국, 50010
- McFarland Clinic - Ames
-
Cedar Rapids, Iowa, 미국, 52403
- Mercy Hospital
-
Cedar Rapids, Iowa, 미국, 52403
- Oncology Associates at Mercy Medical Center
-
Clive, Iowa, 미국, 50325
- Mercy Cancer Center-West Lakes
-
Des Moines, Iowa, 미국, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, 미국, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, 미국, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
-
Maine
-
Bath, Maine, 미국, 04530
- MaineHealth Coastal Cancer Treatment Center
-
Portland, Maine, 미국, 04102
- Maine Medical Center-Bramhall Campus
-
Sanford, Maine, 미국, 04073
- MaineHealth Cancer Care Center of York County
-
Scarborough, Maine, 미국, 04074
- Maine Medical Center- Scarborough Campus
-
-
Maryland
-
Annapolis, Maryland, 미국, 21401
- Anne Arundel Medical Center
-
Baltimore, Maryland, 미국, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, 미국, 21201
- University of Maryland/Greenebaum Cancer Center
-
Columbia, Maryland, 미국, 21044
- Central Maryland Radiation Oncology in Howard County
-
Glen Burnie, Maryland, 미국, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
-
Towson, Maryland, 미국, 21204
- UM Saint Joseph Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48106
- Saint Joseph Mercy Hospital
-
Brighton, Michigan, 미국, 48114
- Saint Joseph Mercy Brighton
-
Livonia, Michigan, 미국, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
-
Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
-
-
Missouri
-
Rolla, Missouri, 미국, 65401
- Delbert Day Cancer Institute at PCRMC
-
Springfield, Missouri, 미국, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, 미국, 63141
- Mercy Hospital Saint Louis
-
-
Montana
-
Billings, Montana, 미국, 59101
- Billings Clinic Cancer Center
-
-
New York
-
Glens Falls, New York, 미국, 12801
- Glens Falls Hospital
-
White Plains, New York, 미국, 10601
- Dickstein Cancer Treatment Center
-
-
North Dakota
-
Grand Forks, North Dakota, 미국, 58201
- Altru Cancer Center
-
-
Pennsylvania
-
Meadowbrook, Pennsylvania, 미국, 19046
- Holy Redeemer Hospital and Medical Center
-
-
South Carolina
-
Anderson, South Carolina, 미국, 29621
- AnMed Health Cancer Center
-
Georgetown, South Carolina, 미국, 29440
- Tidelands Georgetown Memorial Hospital
-
Greenville, South Carolina, 미국, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, 미국, 29601
- Saint Francis Hospital
-
Greer, South Carolina, 미국, 29651
- Gibbs Cancer Center-Pelham
-
Murrells Inlet, South Carolina, 미국, 29576
- MUSC Health Tidelands Health Radiation Therapy Center
-
Spartanburg, South Carolina, 미국, 29303
- Spartanburg Medical Center
-
-
Texas
-
Laredo, Texas, 미국, 78041
- Doctor's Hospital of Laredo
-
-
Utah
-
Salt Lake City, Utah, 미국, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, 미국, 84106
- University of Utah Sugarhouse Health Center
-
-
Wisconsin
-
Appleton, Wisconsin, 미국, 54911
- ThedaCare Regional Cancer Center
-
Wausau, Wisconsin, 미국, 54401
- Aspirus Regional Cancer Center
-
Wisconsin Rapids, Wisconsin, 미국, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Arm I (standard of care)
Patients receive standard of care skin management during radiation therapy for up to 6 weeks. |
Ancillary studies Ancillary studies Receive standard of care
다른 이름들:
|
|
실험적: 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. |
Ancillary studies Ancillary studies Apply Mepitel Film |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 의자: Kimberly Corbin, MD, Mayo Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- A221803
- UG1CA189823 (미국 NIH 보조금/계약)
- NCI-2019-04688 (레지스트리 식별자: NCI Clinical Trial Reporting Program)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .