None listed
Conditions
Brief summary
This is a randomized, non-inferiority, non-blinded, clinical trial with the two treatments StrataXRT and Mepitel Film being compared within each patient. The purpose of this trial is to determine if StrataXRT is as good as Mepitel Film in reducing the severity and duration of radiation-induced dermatitis,
Interventions
StrataXRT versus Mepitel film for radiation-induced dermatitis in patients receiving post-mastectomy radiotherapy for breast cancer.
The purpose of this study is to determine is StrataXRT as good as Mepitel Film in reducing the severity and duration of dermatitis caused by post-mastectomy radiotherapy for breast cancer.
Mepitel Film is a thin, transparent, breathable film which is applied to the skin as a dressing.
StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation tha
StrataXRT versus Mepitel film for radiation-induced dermatitis in patients receiving post-mastectomy radiotherapy for breast cancer. The purpose of this study is to determine is StrataXRT as good as Mepitel Film in reducing the severity and duration of dermatitis caused by post-mastectomy radiotherapy for breast cancer. Mepitel Film is a thin, transparent, breathable film which is applied to the skin as a dressing. StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation that forms a film and lightly bonds to the most superficial skin layer. In order to compare these two treatments we want to test both of them on each patient. Once a patient agrees to enter the trial and is registered, she will be randomly allocated to have Mepitel Film applied to either the lateral (outer) or medial (inner) half of the irradiated area of the chest wall. Mepitel Film will be applied by a nurse at the commencement of radiotherapy and re-applied every 1 – 2 weeks as required during and after radiotherapy until any dermatitis is resolved. StrataXRT will be applied by the patient to the other half of the irradiated area daily throughout radiotherapy and afterwards until any dermatitis is resolved. Duration of intervention will be approximately 10 weeks. Adherence to the intervention will be monitored by clinical nurses by direct observation as well as patient feedback.
Sponsors
Genesis Cancer Care
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically confirmed breast cancer. Recent mastectomy. Suitable for post-mastectomy chest wall and nodal radiotherapy. Able and willing to comply with daily treatments and weekly assessments up to 10 weeks from commencement of radiotherapy Age at least 18 years. Has given written informed consent.
Exclusion criteria
Contraindication to radiotherapy, eg ataxia, telangiectasia. Prior radiotherapy to the breast Skin which is unsuitable for application of Mepitel Film or StrataXRT. Not medically competent to provide informed consent.
Outcome results
None listed