Efficacy Study of Mepitel Film the Prophylaxis of Radiation-Induced Skin Reactions in Breast Cancer Patients

NCT03910595 | Completed

• 1 other identifier: 294-2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In patients undergoing adjuvant radiotherapy for breast cancer, radiation-induced skin toxicities are a common occurrence and adversely impact patients' quality of life (QOL). In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Recently, a phase III randomized trial by Herst et al. (n=78) in New Zealand showed that the prophylactic use of Mepitel Film reduced skin reaction severity by 92% compared to skin treated only with aqueous cream. Mepitel film has not been widely adopted in North America. To validate the efficacy of the film and guide the development of a larger multi-centre phase II study, a pilot study testing the efficacy of the film is proposed. In the study, 30 patients will have the film applied on their breast for the duration of radiation treatment and their skin reactions will be assessed throughout the treatment and after the treatment. The investigators hypothesize that the severity and incidence rates of skin reactions for patients using Mepitel film will be lower when compared to real world data from our centre, and that cosmetic outcomes will be improved with the film.

Conditions

Breast Cancer; Radiation Dermatitis

Keywords

Barrier Film; Mepitel; Quality of Life; Radiation Dermatitis; Skin toxicity

Outcome Measures

Primary Outcomes (1)

• Observable differences between treated and non-treated breasts/chest wall

  Determined by a cosmetic dermatologist from photographs of the treated and non-treated breast/chest wall.

  Within 3 months following radiation

Secondary Outcomes (12)

• Patient reports of acute skin toxicity

  Within 3 months following radiotherapy

• Patient reports of late skin toxicity

  6 months following radiotherapy

• Clinician reports of acute skin toxicity

  Within 3 months following radiotherapy

• Clinician reports of late skin toxicity

  6 months following radiotherapy

• Clinician grading of acute skin toxicity

  Within 3 months following radiotherapy

Study Arms (1)

Mepitel Film Arm

EXPERIMENTAL

This is a single arm trial where all patients will receive the intervention of Mepitel Film.

Other: Mepitel Film

Interventions

Mepitel Film OTHER

Mepitel film is a barrier film that may help in reducing radiation dermatitis by limiting friction.

Mepitel Film Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Patient will receive adjuvant breast or chest wall radiation
• Post-lumpectomy patients with band size of at least 36 inches or cup size of D or larger will be part of the large breast cohort
• Post-lumpectomy patients that do not meet this size requirement will be part of the small or medium sized breast cohort
• Post-mastectomy patients are part of the chest wall radiation cohort
• Can communicate in English or be aided by a hospital translator

You may not qualify if:

• Patient had previous radiation therapy to the treatment area
• Patient had breast reconstruction
• Patient has a Karnofsky Performance Status score \<70
• Patient will have radiation treatment in prone or reverse decubitus positions
• Patient will receive partial breast external beam radiation or brachytherapy
• Patient will receive radiation to the supraclavicular region

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Officials

• Edward LW Chow, MBBS

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients will receive the Mepitel film intervention. This film will be given to patients in one of three patient populations: 1. Patients with large breasts 2. Patients with small or medium sized breasts 3. Patients with chest wall radiation

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: April 10, 2019
• Study Start: March 14, 2019
• Primary Completion: April 28, 2020
• Study Completion: September 8, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CA (1)