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Mepitel Film for Radiation Skin Damage in Breast Cancer

N/A

Waitlist Available

Led By Edward LW Chow, MBBS

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with large breasts [bra size 36 in and/or C cup or greater] and have undergone breast-conserving surgery

Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes

Must not have

Active rash or pre-existing dermatitis within the treatment field

Concomitant cytotoxic chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12 and 24 months following radiotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is being done to see if Mepitel Film is better than the current standard of care for preventing and treating radiation-induced skin reactions in breast cancer patients.

Who is the study for?

This trial is for breast cancer patients with large breasts who've had surgery and are set to receive radiation therapy. It's open to adults over 18, regardless of gender. Those with prior radiotherapy, current chemotherapy, skin conditions in the treatment area, or allergies to adhesives/silicon can't participate.

What is being tested?

The study tests Mepitel Film against standard skin treatments for preventing radiation dermatitis in breast cancer patients receiving radiation. Of the 216 participants, two-thirds will use the film while one-third will get usual care; their skin reactions are then compared.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort or allergic reactions from using Mepitel Film on sensitive post-surgery skin undergoing radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have large breasts and had surgery to remove part of one breast.

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My breast cancer diagnosis was confirmed through tissue examination.

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I am 18 years old or older.

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I have had a mastectomy, with or without reconstruction.

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I am scheduled for a specific type of radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a rash or skin condition in the area to be treated.

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I am currently receiving chemotherapy that kills cancer cells.

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I have had radiation therapy on the area that is now planned to be treated again.

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I need assistance with my daily activities.

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I am scheduled for internal radiation therapy or radiation to both sides of my body.

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I have inflammatory breast cancer or visible skin involvement as I start radiotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12 and 24 months following radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12 and 24 months following radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12 and 24 months following radiotherapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0.

Secondary study objectives

Number of participants with acute radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.

Number of participants with acute radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.

Number of participants with late radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mepitel Film ArmExperimental Treatment1 Intervention

Patients randomized to the Mepitel Film arm will receive the film for the entire duration of their radiation treatment and will be worn up to 2 weeks after completion of radiotherapy.

Group II: Standard of Care ArmActive Control1 Intervention

Patients randomized to the Standard of Care arm will be instructed to use the institutional standard of care skin treatments for the entire duration of their radiation treatment and up to 2 weeks after completion of radiotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mepitel Film

2019

Completed Phase 3

~300

0 / 11Eligibility criteria met