Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus (MEDISKIN)

Angelos Kassianos

Status: Not yet enrolling

Conditions: Breast Cancer; Head and Neck Cancer

Treatments: Other: MEDISKIN cream; Other: Panthenol cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05588973

CUT_DN_02

RESTART 2016-2020 SEED (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

50 patients will be randomized to the MEDISKIN group and 50 to the panthenol group. Everyone will start using their cream from the start of the treatment and will continue for 2 weeks after the end of the radiation therapy (twice a day). If there are cases of patients using panthenol and it is deemed necessary based on symptoms to use MEDISKIN then they will automatically change group. Before starting to use the skin cosmetic products, patients will be asked to test the product for any allergic reactions. The "mini-patch test" which is standard of practice is carried out by using the substance on the inner elbow or wrist for 24 hours and observing for any reactions.

Treatment:

Other: MEDISKIN cream

Control group

Placebo Comparator group

Description:

The group will be using panthenol istead of the MEDISKIN product

Treatment:

Other: Panthenol cream