Official Title
An Efficacy Study of Mepitel Film in the Prophylaxis of Radiation-Induced Skin Reactions in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy
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). Patients with large breasts or patients
receiving chest wall radiation may be more likely to have worse skin reactions
following radiation. 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 prevented moist desquamation (26% vs. 0%,
p < 0.001) and reduced skin reaction severity by 92% (p < 0.001) compared
to skin treated only with aqueous cream. Another study by Moller et al. (n=101)
in Denmark reported a non-significant improvement in observer-rated radiation
dermatitis with the film (p=0.1) compared to cream, and significant
improvements in several patient-reported outcomes. Moreover, patients with
breast cancer complain of hyperpigmentation in the radiated area during and
after radiation.
Mepitel Film has not been widely adopted in North American
clinical practice. To further study and validate the efficacy of Mepitel Film
in preventing acute skin reactions caused by breast radiation and elucidate its
efficacy in preventing poor cosmetic outcomes, a phase II efficacy study of
three patient populations will be conducted:
- Patients with large breasts
- Patients with small or medium sized breasts
- Patients with chest wall radiation
The results of the phase II efficacy study can guide the
development of a subsequent multi-centre phase II and III trials to further
validate the use of Mepitel film and increase its adoption rate.
The primary objective is to examine the efficacy of Mepitel
film in the prophylaxis of radiation-induced skin reactions. Secondary
objectives include an evaluation of patient-reported and healthcare
professional (HCP)-reported skin toxicities including moist desquamation with
the use of Mepitel film.
Radiation oncologists will first introduce the study to
their patients in their breast clinic, showing a sample of the product and also
pictures from the trial conducted in New Zealand. Patients if interested may be
provided a patient information sheet to review at home. Then, patients will be
approached by a CRA at their radiation planning appointment to review all
information and obtain informed consent.
All patients will receive Mepitel film for the duration of
treatment. Radiation treatment will be delivered as prescribed by the treating
radiation oncologist and may include a variety of techniques and beam
modifiers.
Trained clinical research assistants (CRA) or the radiation
review nurse will apply the Mepitel film for patients prior to their first
radiation treatment at a designated clinic room and will check daily prior to
radiation that the breast/chest wall has not been distorted by the film. If the
film needs to be readjusted, the CRAs or nurses will remove peeling sections of
film and reapply where needed. The film will be removed two weeks post
radiation treatment.
Patients will complete evaluations once a week at their
regular review clinic visit and will be assessed by an HCP or CRA. At the last
treatment or last review appointment, a photo of the patient's breasts/chest
wall will be taken, and they will be asked to complete an assessment. An HCP
will also conduct an assessment.
After completion of radiation, patients will be called at
week 1 and weeks 3-6 to assess endpoints. Patients will be asked to return for
a 2-week, 3-month, and 6-month follow-up assessment where photos of their
breasts/chest wall will be taken, and they will complete their personal
assessments. The film will be removed at the 2-week follow-up appointment. The
3-month follow-up assessment will occur at the same time as their regular
clinic follow-up with their radiation oncologist. At the 3-month and 6-month
follow-up assessment, an HCP will also an assessment.
Trial Description
Primary Outcome:
- Observable differences between treated and non-treated breasts/chest wall
Secondary Outcome:
- Patient reports of acute skin toxicity
- Patient reports of late skin toxicity
- Clinician reports of acute skin toxicity
- Clinician reports of late skin toxicity
- Clinician grading of acute skin toxicity
- Clinician grading of late skin toxicity
- Degree of acute skin toxicity and interference with daily functioning
- Degree of late skin toxicity and interference with daily functioning
- Long-term changes in skin pigmentation
- Acute changes in breast cosmesis
- Late changes in breast cosmesis
- Film Integrity Assessment
In patients undergoing adjuvant radiation therapy for breast cancer, radiation-induced skin
toxicities are a common occurrence and adversely impact patients' quality of life (QOL).
Patients with large breasts or patients receiving chest wall radiation may be more likely to
have worse skin reactions following radiation. 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 prevented moist desquamation (26% vs. 0%, p < 0.001) and reduced skin
reaction severity by 92% (p < 0.001) compared to skin treated only with aqueous cream.
Another study by Moller et al. (n=101) in Denmark reported a non-significant improvement in
observer-rated radiation dermatitis with the film (p=0.1) compared to cream, and significant
improvements in several patient-reported outcomes. Moreover, patients with breast cancer
complain of hyperpigmentation in the radiated area during and after radiation.
Mepitel Film has not been widely adopted in North American clinical practice. To further
study and validate the efficacy of Mepitel Film in preventing acute skin reactions caused by
breast radiation and elucidate its efficacy in preventing poor cosmetic outcomes, a phase II
efficacy study of three patient populations will be conducted:
1. Patients with large breasts
2. Patients with small or medium sized breasts
3. Patients with chest wall radiation
The results of the phase II efficacy study can guide the development of a subsequent
multi-centre phase II and III trials to further validate the use of Mepitel film and increase
its adoption rate.
The primary objective is to examine the efficacy of Mepitel film in the prophylaxis of
radiation-induced skin reactions. Secondary objectives include an evaluation of
patient-reported and healthcare professional (HCP)-reported skin toxicities including moist
desquamation with the use of Mepitel film.
Radiation oncologists will first introduce the study to their patients in their breast
clinic, showing a sample of the product and also pictures from the trial conducted in New
Zealand. Patients if interested may be provided a patient information sheet to review at
home. Then, patients will be approached by a CRA at their radiation planning appointment to
review all information and obtain informed consent.
All patients will receive Mepitel film for the duration of treatment. Radiation treatment
will be delivered as prescribed by the treating radiation oncologist and may include a
variety of techniques and beam modifiers.
Trained clinical research assistants (CRA) or the radiation review nurse will apply the
Mepitel film for patients prior to their first radiation treatment at a designated clinic
room and will check daily prior to radiation that the breast/chest wall has not been
distorted by the film. If the film needs to be readjusted, the CRAs or nurses will remove
peeling sections of film and reapply where needed. The film will be removed two weeks post
radiation treatment.
Patients will complete evaluations once a week at their regular review clinic visit and will
be assessed by an HCP or CRA. At the last treatment or last review appointment, a photo of
the patient's breasts/chest wall will be taken, and they will be asked to complete an
assessment. An HCP will also conduct an assessment.
After completion of radiation, patients will be called at week 1 and weeks 3-6 to assess
endpoints. Patients will be asked to return for a 2-week, 3-month, and 6-month follow-up
assessment where photos of their breasts/chest wall will be taken, and they will complete
their personal assessments. The film will be removed at the 2-week follow-up appointment. The
3-month follow-up assessment will occur at the same time as their regular clinic follow-up
with their radiation oncologist. At the 3-month and 6-month follow-up assessment, an HCP will
also an assessment.
View this trial on ClinicalTrials.gov
