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

Not currently recruiting at 50 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Mepitel Film in reducing skin redness and peeling caused by radiation therapy in breast cancer patients who have undergone a mastectomy. Mepitel Film is applied to the skin to determine its protective effects against these side effects. Participants will either receive standard skin care or have Mepitel Film applied weekly during their radiation treatment. The trial seeks individuals who have had a mastectomy, have not received previous radiation on the treatment area, and are beginning a specific type of radiation therapy. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that Mepitel Film is likely to be safe for humans?

Research has shown that Mepitel Film is generally safe for preventing skin problems during radiation therapy. In one study, it reduced skin issues and sped up skin recovery. Patients reported comfort when using it, according to survey responses. Other studies confirm that Mepitel Film is safer and more effective at reducing severe skin reactions than regular skincare creams. Overall, evidence suggests that Mepitel Film is a safe choice for individuals undergoing radiation therapy, especially those with breast cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard of care for radiation dermatitis, which typically involves topical creams and dressings, Mepitel Film offers a unique protective barrier applied weekly before radiation therapy. This film is designed to minimize skin irritation by reducing friction and exposure to radiation, potentially leading to less severe skin reactions. Researchers are excited about Mepitel Film because it promises a more comfortable experience for patients, potentially easing the common side effects of radiation therapy following a mastectomy.

What evidence suggests that Mepitel Film might be an effective treatment for radiation dermatitis?

Studies have shown that Mepitel Film effectively reduces skin problems caused by radiation therapy. In this trial, some participants will have Mepitel Film applied to the breast or chest wall weekly before radiation therapy. Research indicates that Mepitel Film can decrease the severity of skin reactions by 92% compared to using only a standard cream. This results in less redness and peeling for patients undergoing radiation. In breast cancer patients, the film has proven safe and particularly effective, making it a recommended choice for reducing skin damage during treatment. ^{3 4 6 7 8}

Who Is on the Research Team?

Kimberly Corbin, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11919610/

Mepitel® film versus standard care for the prevention of ... The primary outcome was to compare Mepitel® Film versus standard treatment in preventing radiotherapy skin toxicity onset.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2347562524001525

Mepitel film for the prevention of radiation dermatitis: A ... Conclusions. MF is a safe and effective intervention for preventing acute RD. It should be recommended in breast cancer patients where the data is more robust.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03910595

Efficacy Study of Mepitel Film the Prophylaxis of Radiation ... The prophylactic use of Mepitel Film reduced skin reaction severity by 92% compared to skin treated only with aqueous cream.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12361805/

Pilot evaluation of Mepitel Film and StrataXRT for the ... Radiation dermatitis (RD) can significantly impact the quality of life in breast cancer (BC) patients undergoing radiation therapy (RT).

5. practicalradonc.org practicalradonc.org/article/S1879-8500(20)30217-4/abstract

A Feasibility Study of Mepitel Film for the Prevention ... Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiation therapy: Results of a randomized trial.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000266

Mepitel® film versus standard care for the prevention of ... The use of Mepitel Film highlights a lower rate of skin toxicity and skin recovery time. The device was well tolerated, as reported by questionnaires.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268185/

Mepitel film for the prevention of radiation dermatitis MF is a safe and effective intervention for preventing acute RD. It should be recommended in breast cancer patients where the data is more robust.

8. tro.amegroups.org tro.amegroups.org/article/view/4683/html

Can the dermatitis from the hot spot be minimised by barrier ... Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of ...