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Mepitel Film for Radiation Skin Damage in Breast Cancer

Phase 3

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12 and 24 months following radiotherapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,406 Total Patients Enrolled

29 Trials studying Breast Cancer

15,920 Patients Enrolled for Breast Cancer

Edward LW Chow, MBBSPrincipal InvestigatorSunnybrook Health Sciences Centre

2 Previous Clinical Trials

80 Total Patients Enrolled

2 Trials studying Breast Cancer

80 Patients Enrolled for Breast Cancer

Media Library

Mepitel Film (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04166799 — Phase 3

Breast Cancer Research Study Groups: Mepitel Film Arm, Standard of Care Arm

Breast Cancer Clinical Trial 2023: Mepitel Film Highlights & Side Effects. Trial Name: NCT04166799 — Phase 3

Mepitel Film (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166799 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers looking for new participants in this trial right now?

"The aforementioned website provides evidence that this study is no longer recruiting patients. This trial was first posted on January 30th, 2020 and the most recent update occurred on July 29th, 2022. It's worth mentioning that there are 2,933 other trials currently looking for participants."

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