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

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ClinicalTrials.gov Identifier: NCT03910595
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Edward Chow, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation Dermatitis Other: Mepitel Film Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Efficacy Study of Mepitel Film in the Prophylaxis of Radiation-Induced Skin Reactions in Breast Cancer Patients Undergoing Adjuvant Radiotherapy
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Mepitel Film Arm
This is a single arm trial where all patients will receive the intervention of Mepitel Film.
Other: Mepitel Film
Mepitel film is a barrier film that may help in reducing radiation dermatitis by limiting friction.




Primary Outcome Measures :
  1. Observable differences between treated and non-treated breasts/chest wall [ Time Frame: Within 3 months following radiation ]
    Determined by a cosmetic dermatologist from photographs of the treated and non-treated breast/chest wall.


Secondary Outcome Measures :
  1. Patient reports of acute skin toxicity [ Time Frame: Within 3 months following radiotherapy ]
    Measured by the Skin Symptom Assessment (SSA); subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much"

  2. Patient reports of late skin toxicity [ Time Frame: 6 months following radiotherapy ]
    Measured by the SSA; subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much"

  3. Clinician reports of acute skin toxicity [ Time Frame: Within 3 months following radiotherapy ]
    Measured by the SSA; subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much"

  4. Clinician reports of late skin toxicity [ Time Frame: 6 months following radiotherapy ]
    Measured by the SSA; subscales for itchiness, pain/soreness, blistering/peeling, redness, discolouration/darkness, swelling, and trouble fitting brassieres graded as "not at all", "a little", "quite a bit", or "very much"

  5. Clinician grading of acute skin toxicity [ Time Frame: Within 3 months following radiotherapy ]
    Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE); graded on a scale from 0 (best) to 4 (worst)

  6. Clinician grading of late skin toxicity [ Time Frame: 6 months following radiotherapy ]
    Measured by the NCI CTCAE; graded on a scale from 0 (best) to 4 (worst)

  7. Degree of acute skin toxicity and interference with daily functioning [ Time Frame: Within 3 months following radiotherapy ]
    Measured by the Radiation Induced Skin Reaction Assessment System (RISRAS); researcher subscales for erythema and dry desquamation rated from 0 (best) to 4 (worst); researcher subscale for moist desquamation rated from 0 (best) to 6 (worst); researcher subscale for necrosis rated from 0 (best) to 10 (worst); patient subscales for tenderness/discomfort/pain, itchiness, burning sensation, and interference with daily activities rated from 0 (best) to 3 (worst).

  8. Degree of late skin toxicity and interference with daily functioning [ Time Frame: 6 months following radiotherapy ]
    Measured by the RISRAS; researcher subscales for erythema and dry desquamation rated from 0 (best) to 4 (worst); researcher subscale for moist desquamation rated from 0 (best) to 6 (worst); researcher subscale for necrosis rated from 0 (best) to 10 (worst); patient subscales for tenderness/discomfort/pain, itchiness, burning sensation, and interference with daily activities rated from 0 (best) to 3 (worst).

  9. Long-term changes in skin pigmentation [ Time Frame: Changes from baseline to 6 months following radiotherapy ]
    Measured by photographs of the treated and non-treated breast and graded by a cosmetic dermatologist

  10. Acute changes in breast cosmesis [ Time Frame: Within 3 months following radiotherapy ]
    Measured by the European Organization for Research and Treatment of Cancer (EORTC) Breast Cosmetic Rating System; subscales for breast size, breast shape, location of areola/nipple, shape of areola/nipple, tanning, pallor, breast edema, appearance of scar, and telangiectasia graded from 0 (best) to 3 (worst); overall grade assigned from 0 (best) to 2 (worst).

  11. Late changes in breast cosmesis [ Time Frame: 6 months following radiotherapy ]
    Measured by the EORTC Breast Cosmetic Rating System; subscales for breast size, breast shape, location of areola/nipple, shape of areola/nipple, tanning, pallor, breast edema, appearance of scar, and telangiectasia graded from 0 (best) to 3 (worst); overall grade assigned from 0 (best) to 2 (worst).

  12. Film Integrity Assessment [ Time Frame: Until film is removed, 2 weeks following radiotherapy ]
    Evaluated daily prior to the patient's radiotherapy treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910595


Contacts
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Contact: Edward LW Chow, MBBS (416) 480-4974 Edward.Chow@sunnybrook.ca
Contact: Caitlin Yee, BSc caitlin.yee@sunnybrook.ca

Locations
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Canada, Ontario
Odette Cancer Centre, Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Edward Chow, MBBS         
Principal Investigator: Edward Chow, MBBS         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Edward LW Chow, MBBS Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Edward Chow, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03910595     History of Changes
Other Study ID Numbers: 294-2018
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Edward Chow, Sunnybrook Health Sciences Centre:
Barrier Film
Mepitel
Quality of Life
Radiation Dermatitis
Skin toxicity

Additional relevant MeSH terms:
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Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries