Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus

Pilot Double-blind Randomized Controlled Clinical Trial for the Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus

The treatment of cancer as a multidimensional disease has improved in recent years with the development of new chemotherapies, targeted biological therapies or radiation therapy protocols and have led to an overall improvement in the survival of oncology patients. These treatments often cause adverse effects on the skin, which can be accompanied by physical and mental suffering and have a significant impact on patients' quality of life. Improving the quality of life of patients is today a therapeutic challenge. The objective of this clinical study is to assess the tolerability of an innovative skin cosmetic product that will be developed specifically for use during curative anticancer treatments, as well as to study the impact on quality of life of skin side effects caused by the treatments.

Inclusion Criteria:

• over 18 years of age,
• understand and be able to provide signed consent for the purpose of the research,
• be diagnosed with breast or head and neck cancer,
• undergo subfractionated radiotherapy of the breast in 15 sessions of a total dose of 40-42Gy, with or without the administration of a booster dose (boost),
• to know the Greek or English language well
• any wound should have healed after radiotherapy. The criteria will be evaluated by the medical staff of the hospital.

Exclusion Criteria:

• those who do not meet the aforementioned inclusion criteria as well as:
• those who suffer from inflammatory cancer,
• those who have untreated wounds and/or other serious dermatological problems
• those with severe/extensive burns
• those who suffer from serious mental disorders (dementia, drug addiction, etc.) that require intensive treatment or monitoring,
• those who have a sensitivity/allergy to any of the product's ingredients. The criteria will be evaluated by the medical staff of the hospital.