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Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

Primary Purpose

Breast Carcinoma, Mastectomy Patient

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Wound Dressing Material
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • 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.

Sites / Locations

  • Fremont - Rideout Cancer Center
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Beebe South Coastal Health CampusRecruiting
  • Helen F Graham Cancer CenterRecruiting
  • Medical Oncology Hematology Consultants PARecruiting
  • Beebe Health CampusRecruiting
  • John Fitzgerald Kennedy Medical CenterRecruiting
  • McFarland Clinic PC - AmesRecruiting
  • Mercy HospitalRecruiting
  • Oncology Associates at Mercy Medical CenterRecruiting
  • Mercy Cancer Center-West LakesRecruiting
  • Iowa Methodist Medical CenterRecruiting
  • Medical Oncology and Hematology Associates-Des MoinesRecruiting
  • Mercy Medical Center - Des MoinesRecruiting
  • MaineHealth Coastal Cancer Treatment CenterRecruiting
  • Maine Medical Center-Bramhall CampusRecruiting
  • MaineHealth Cancer Care Center of York CountyRecruiting
  • Maine Medical Center- Scarborough CampusRecruiting
  • Anne Arundel Medical CenterRecruiting
  • University of Maryland/Greenebaum Cancer CenterRecruiting
  • Sinai Hospital of BaltimoreRecruiting
  • UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
  • Saint Joseph Mercy HospitalRecruiting
  • Saint Joseph Mercy BrightonRecruiting
  • Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
  • Mayo Clinic in Rochester
  • Delbert Day Cancer Institute at PCRMCRecruiting
  • Mercy Hospital Saint LouisRecruiting
  • Mercy Hospital SpringfieldRecruiting
  • Billings Clinic Cancer CenterRecruiting
  • Glens Falls Hospital
  • Dickstein Cancer Treatment CenterRecruiting
  • Altru Cancer CenterRecruiting
  • Holy Redeemer Hospital and Medical CenterRecruiting
  • AnMed Health Cancer CenterRecruiting
  • Tidelands Georgetown Memorial HospitalRecruiting
  • Saint Francis HospitalRecruiting
  • Saint Francis Cancer CenterRecruiting
  • Gibbs Cancer Center-PelhamRecruiting
  • MUSC Health Tidelands Health Radiation Therapy CenterRecruiting
  • Spartanburg Medical CenterRecruiting
  • Doctor's Hospital of LaredoRecruiting
  • Huntsman Cancer Institute/University of UtahRecruiting
  • ThedaCare Regional Cancer CenterRecruiting
  • Aspirus Regional Cancer CenterRecruiting
  • Aspirus Cancer Care - Wisconsin RapidsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard of care)

Arm II (Mepitel Film)

Arm Description

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

Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.

Outcomes

Primary Outcome Measures

Serially measured patient-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
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.

Secondary Outcome Measures

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
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.
Serially measured non-blinded institutional provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
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.
Serially measured combined patient- and provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
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.

Full Information

First Posted
July 26, 2021
Last Updated
April 3, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04989504
Brief Title
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
Official Title
Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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 every week 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, and 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Mastectomy Patient

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
Arm Title
Arm II (Mepitel Film)
Arm Type
Experimental
Arm Description
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
Standard of Care
Intervention Description
Receive standard of care
Intervention Type
Device
Intervention Name(s)
Wound Dressing Material
Intervention Description
Apply Mepitel Film
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Serially measured patient-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
Description
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.
Time Frame
Up to 5 months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 2 months
Title
Serially measured non-blinded institutional provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
Description
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.
Time Frame
Up to 5 months
Title
Serially measured combined patient- and provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
Description
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.
Time Frame
Up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Corbin, MD
Phone
855-776-001
Email
corbin.kimberly@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Corbin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Fremont - Rideout Cancer Center
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Individual Site Status
Suspended
Facility Name
Gene Upshaw Memorial Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Individual Site Status
Suspended
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
John Fitzgerald Kennedy Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
561-964-2662
First Name & Middle Initial & Last Name & Degree
Georges F. Hatoum
Facility Name
McFarland Clinic PC - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-239-4734
Email
ksoder@mcfarlandclinic.com
First Name & Middle Initial & Last Name & Degree
Debra M. Prow
Facility Name
Mercy Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
319-365-4673
First Name & Middle Initial & Last Name & Degree
Deborah W. Wilbur
Facility Name
Oncology Associates at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
319-363-2690
First Name & Middle Initial & Last Name & Degree
Deborah W. Wilbur
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-6727
First Name & Middle Initial & Last Name & Degree
Joshua Lukenbill
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Joshua Lukenbill
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
MaineHealth Coastal Cancer Treatment Center
City
Bath
State/Province
Maine
ZIP/Postal Code
04530
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-9171
Email
protocols@AllianceNCTN.org
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Maine Medical Center-Bramhall Campus
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-885-7565
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
MaineHealth Cancer Care Center of York County
City
Sanford
State/Province
Maine
ZIP/Postal Code
04073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-459-1600
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Maine Medical Center- Scarborough Campus
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-8090
Email
wrighd@mmc.org
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
443-481-1320
Email
research@luminishealth.org
First Name & Middle Initial & Last Name & Degree
Mary E. Young
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-888-8823
First Name & Middle Initial & Last Name & Degree
Sarah A. Mcavoy
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-601-6120
Email
pridgely@lifebridgehealth.org
First Name & Middle Initial & Last Name & Degree
Leslie R. Holmes
Facility Name
UM Baltimore Washington Medical Center/Tate Cancer Center
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-553-8100
First Name & Middle Initial & Last Name & Degree
Sarah A. Mcavoy
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Samir Narayan
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Kimberly S. Corbin
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
573-458-7504
Email
research@phelpshealth.org
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-251-7066
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
417-269-4520
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-996-2663
Email
research@billingsclinic.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Glens Falls Hospital
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dickstein Cancer Treatment Center
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
914-849-7582
Email
mcortese@wphospital.org
First Name & Middle Initial & Last Name & Degree
Randy E. Stevens
Facility Name
Altru Cancer Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-780-6520
First Name & Middle Initial & Last Name & Degree
Grant R. Seeger
Facility Name
Holy Redeemer Hospital and Medical Center
City
Meadowbrook
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
215-938-3551
First Name & Middle Initial & Last Name & Degree
Sheena K. Jain
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-512-4651
Email
rhonda.ballew@anmedhealth.org
First Name & Middle Initial & Last Name & Degree
Leander Cannick
Facility Name
Tidelands Georgetown Memorial Hospital
City
Georgetown
State/Province
South Carolina
ZIP/Postal Code
29440
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
843-545-5600
Email
broe@tidelandshealth.org
First Name & Middle Initial & Last Name & Degree
Jennifer L. Harper
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-603-6213
Email
melissa_beckman@bshsi.org
First Name & Middle Initial & Last Name & Degree
Jennifer Vogel
Facility Name
Saint Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-603-6213
Email
melissa_beckman@bshsi.org
First Name & Middle Initial & Last Name & Degree
Jennifer Vogel
Facility Name
Gibbs Cancer Center-Pelham
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-560-6104
Email
kmertz-rivera@gibbscc.org
First Name & Middle Initial & Last Name & Degree
Amarinthia (Amy) Curtis
Facility Name
MUSC Health Tidelands Health Radiation Therapy Center
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
843-652-1607
Email
broe@tidelandshealth.org
First Name & Middle Initial & Last Name & Degree
Jennifer L. Harper
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-560-6104
Email
kmertz-rivera@gibbscc.org
First Name & Middle Initial & Last Name & Degree
Amarinthia (Amy) Curtis
Facility Name
Doctor's Hospital of Laredo
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
956-523-2650
First Name & Middle Initial & Last Name & Degree
Gary W. Unzeitig
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-424-2100
Email
cancerinfo@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Matthew M. Poppe
Facility Name
ThedaCare Regional Cancer Center
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
920-364-3604
Email
ResearchDept@thedacare.org
First Name & Middle Initial & Last Name & Degree
Shaneli A. Fernando
Facility Name
Aspirus Regional Cancer Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-405-6866
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang
Facility Name
Aspirus Cancer Care - Wisconsin Rapids
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
715-422-7718
First Name & Middle Initial & Last Name & Degree
Andrew J. Huang

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

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