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Mepitel Film for Radiation Dermatitis in Breast Cancer Patients Post-Mastectomy
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis)
No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 months
Awards & highlights
Study Summary
This trial studies Mepitel Film for reducing radiation dermatitis in patients with breast cancer during radiation therapy after a mastectomy.
Who is the study for?
This trial is for breast cancer patients who've had a mastectomy and are scheduled for radiation therapy without active rashes, inflammatory breast cancer, or severe skin conditions. They shouldn't have had prior radiotherapy in the area, be allergic to adhesives, or be on cytotoxic chemotherapy. Participants must speak English and have a life expectancy over 2 years.Check my eligibility
What is being tested?
The study is testing Mepitel Film's effectiveness in reducing skin redness and peeling caused by radiation therapy in post-mastectomy breast cancer patients. It involves questionnaire administration and quality-of-life assessments to evaluate patient experiences.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort or an allergic reaction to the Mepitel Film dressing material used during radiation treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any active collagen vascular diseases like lupus.
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I do not have inflammatory breast cancer or visible skin involvement.
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I do not have any health conditions that would limit my life to less than 2 years.
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I have never had an organ or bone marrow transplant.
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I can speak and read English.
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I do not have an active rash or skin condition in the area to be treated.
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I am scheduled for standard photon radiation therapy.
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I am not on any chemotherapy, but I may be taking hormone therapy or HER2 treatments.
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My breast cancer has been confirmed and staged.
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I have not had radiation therapy on the area to be treated.
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I had a mastectomy recently, with or without reconstruction.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serially measured patient-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
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
Serially measured combined patient- and provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
Serially measured non-blinded institutional provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (Mepitel Film)Experimental Treatment3 Interventions
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
Group II: Arm I (standard of care)Active Control3 Interventions
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
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Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,422 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,451 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Kimberly Corbin, MDStudy ChairMayo Clinic
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active collagen vascular diseases like lupus.I do not have inflammatory breast cancer or visible skin involvement.I do not have any health conditions that would limit my life to less than 2 years.I have never had an organ or bone marrow transplant.I can speak and read English.I do not have an active rash or skin condition in the area to be treated.I am scheduled for standard photon radiation therapy.I am not on any chemotherapy, but I may be taking hormone therapy or HER2 treatments.My breast cancer has been confirmed and staged.I have not had radiation therapy on the area to be treated.I had a mastectomy recently, with or without reconstruction.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (standard of care)
- Group 2: Arm II (Mepitel Film)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the possible side effects of using Wound Dressing Material?
"Wound Dressing Material is considered to be safe because it has gone through multiple rounds of clinical trials, receiving a 3 on our team's safety scale."
Answered by AI
Is this research project happening in more than one state within the US?
"There are 11 hospitals participating in this trial, which include Mercy Hospital Springfield, Saint Francis Hospital, and Glens Falls Hospital."
Answered by AI
Are more people needed for this experiment?
"The clinical trial is recruiting patients, as indicated by the most recent information on clinicaltrials.gov. This particular study was first posted on 6/15/2022 and edited last on 8/2/2022; it is looking to enroll 216 individuals at 11 different sites."
Answered by AI
How many research subjects are needed for this trial?
"To carry out this trial, we need to enroll 216 willing participants that meet the specified inclusion criteria. These patients can come from different locations, such as Mercy Hospital Springfield in Springfield, Missouri and Saint Francis Hospital in Greenville, South carolina."
Answered by AI
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