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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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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