Short summary

Breast cancer patients in post-operative radiotherapy (RT) often experience acute skin reactions like erythema, pain, itching and oversensitivity. In 2014 a New Zealand RCT investigated the prophylactic use of safetac-based film, Mepitel Film, on half of the breast during RT compared to cream, resulting in significant differences in skin moist desquamation (0% vs. 26%). Despite changes in treatment modalities in Denmark toward lower total RT doses, the level of RT-induced skin toxicity could still be of great importance for the patients. The aim of this study is patient-reported symptoms and patient-reported experiences with the prophylactic use of Mepitel Film compared to standard cream treatment.

Rationale

The use of Mepitel Film in the RCT from New Zealand resulted in significant differences in the acute morbidity of the skin. However, the clinical experience in Denmark with the new RT treatment modalities for breast cancer patients with lower total doses and less treatment fractions indicate less severe skin toxicity than the old treatment modalities.

The primary endpoint of this study is to investigate if prophylactic use of Mepitel Film to prevent severe skin reactions makes a difference for the patient experience of their RT induced skin reactions compared to treating the symptoms when they appear with cream according to present clinical guidelines. Additional to the patient-reported experiences with the prophylactic use of Mepitel Film, the patients are asked to report their acute skin symptoms in the area with or without Mepitel Film at the end of treatment and two weeks after treatment. Secondary, the differences in the acute skin toxicity of the medial and lateral side of the breast are graded by two radiotherapists.

Description of the cohort

Danish adult breast cancer patients in post-operative radiotherapy at the Departments of Oncology in Vejle, Herning/Aarhus and Odense.

Data and biological material

Questionnaire for the radiotherapists:

• Information regarding demographics, treatment modality, smoking habits and comorbidity.
• Information about film application and adjustments during the course of treatment.  
• Severity of skin reactions on the medial and lateral side of the breast graded by 2 radiotherapists according to RTOG scale of acute radiotherapy-induced skin toxicity.

Questionnaire for the patient:

• Patient-reported symptoms of the skin with Mepitel Film vs. the skin treated with cream.
• Patient-reported experience with the use of Mepitel Film and preferences regarding Mepitel Film vs. treatment with cream.
• Patient-reported general health and QOL.

Collaborating researchers and departments

Department of Oncology, Veje Hospital

• Clinical Nurse Specialist Karina Olling
• Hospital physician Martin Berg

Department of Oncology, Aarhus University Hospital

• Clinical Nurse Specialist Anne-Mette Iversen

Department of Oncology, Herning Hospital

• Bente Heislund, Stråleterapeut

Department of Oncology, Odense University Hospital

• Radiotherapy nurse Inger Habæk
• Clinical Nurse Specialist Pia Krause Møller
• Hospital physician Ebbe Lorentzen, PhD
• Professor Carsten Brink, PhD
• Professor Marianne Ewertz DMSc