Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis

Inclusion Criteria:

• Radiation therapy for Breast Cancer
• Age >= 18 years
• Written informed consent

Exclusion Criteria:

• Ulcerated cancer at beginning of radiation therapy
• Skin lesions in the radiation area before start of radiation therapy
• Known allergies, hypersensitivity or reactions against one of the constituents of theinvestigational product [5]
• Any neurological or psychiatric conditions that, in the evaluation of the treatingphysician, deem the patient incapable to participate in the study
• Other clinically significant concomitant disease states (e.g., renal failure, hepaticdysfunction, cardiovascular disease, etc.) as judged by the PI The following criteria are exclusion criteria for the conduct of the radiation therapy,which is prerequisite for inclusion into the study. Thus, such patients will anyway notmeet the inclusion criteria and are explicitly excluded from participation:
• Women who are pregnant or breast feeding
• Lack of safe contraception, defined as: Female participants of childbearing potential,not using and not willing to continue using a medically reliable method ofcontraception for the entire study duration, such as oral, injectable, or implantablecontraceptives, or intrauterine contraceptive devices, or who are not using any othermethod considered sufficiently reliable by the investigator in individual cases.
• Please note that female participants who are surgically sterilised / hysterectomisedor post-menopausal for longer than 2 years are not considered as being of childbearing potential.