Mepitel Film for Radiation Dermatitis in Breast Cancer Patients Post-Mastectomy

Recruiting at 49 trial locations

Overseen By Kimberly Corbin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Adhesive allergy, Inflammatory breast cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

216 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow endocrine therapy and HER2 directed therapies. It does not allow cytotoxic chemotherapy.

What data supports the effectiveness of the treatment Mepitel Film for radiation dermatitis in breast cancer patients post-mastectomy?

Research shows that Mepitel Film can significantly reduce skin reactions caused by radiation in breast cancer patients, making it easier for patients to tolerate treatment and improving their satisfaction. It has been found to be more cost-effective compared to other dressings used for managing severe skin reactions. ^{1 2 3 4 5}

Is Mepitel Film safe for use in humans?

Mepitel Film has been used in studies with breast cancer patients undergoing radiotherapy and was found to be easy to use, reducing skin side effects and improving patient satisfaction. It has been tested in multiple trials, showing a reduction in adverse skin reactions, suggesting it is generally safe for human use. ^{1 2 3 4 5}

How does Mepitel Film treatment differ from other treatments for radiation dermatitis in breast cancer patients?

Mepitel Film is unique because it is a protective film applied directly to the skin to prevent or reduce radiation dermatitis (skin irritation from radiation therapy). It is easy to use, reduces adverse skin reactions, and improves patient satisfaction compared to traditional foam dressings, which are often used after skin damage occurs. ^{1 2 3 4 5}

Research Team

Kimberly Corbin, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients receive either standard of care skin management or Mepitel Film applied weekly during radiation therapy

6 weeks

Weekly visits for radiation therapy

Initial Follow-up

Participants are monitored for skin reactions and effectiveness of the treatment

7-14 days

1 visit (in-person)

Extended Follow-up

Participants are monitored for long-term safety and effectiveness

Up to 2 years

Visits at 3 months, 6 months, 1 year, and 2 years

Treatment Details

Interventions

• Mepitel Film

Trial Overview 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.

Participant Groups

Group I: Arm II (Mepitel Film) Experimental Treatment 3 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 Control 3 Interventions

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

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Mepitel film for the prevention and treatment of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Radiotherapy-induced skin reactions: prevention and cure. [2014]

3. England pubmed.ncbi.nlm.nih.gov

The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Mepitel Film for the Prevention of Breast Radiation Dermatitis in a Canadian Center. [2021]