Skin and Connective Tissue Diseases

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Hygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and Cicaderma ointment application)

Preventive standard cares of the site including hygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and a maximum of one topical treatment

Cicaderma ointment (2 applications / day: after the radiotherapy session) and in the evening) + simple hygiene rules

cicaderma + simple hygiene rules

Simple hygiene rules according to the site recommandations including eventually a maximum of one topical treatment

Simple hygiene rules and a maximum of one topical treatment

Séverine METZGER

Youlia KIROVA, MD PhD

Youlia KIROVA, MD

Séverine RACADOT, MD

Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade \> 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

Breast cancer is the most common cancer in women. It accounts for more than 1/3 of new cancer cases and is the 1st cause of death for women.

Management usually includes tumorectomy or mastectomy precede or not by a chemotherapy, then adjuvant irradiation that can be supplemented with adjuvant chemotherapy and / or hormone therapy.

Radiotherapy uses ionizing radiation (photons, electrons ...) to destroy cancer cells and consists in precisely directing these radiations on the area to be treated while preserving as much as possible healthy tissues and surrounding organs.

Radiation-induced dermatitis is a skin lesion that occurs after exposure to ionizing radiation and is commonly seen in patients. Acute radiodermatitis occurs in the days or weeks following the start of irradiation with different degrees of severity (dry or exsudative radiodermatitis, acute radionecrosis) They are responsible for an alteration of patients' quality of life (pain, sensitivity to UV radiation, discomfort sensations ...), which may lead to a temporary or even permanent therapeutic interruption and reduce the probability of tumor control.

The management of these dermatitis is very heterogeneous, no study having demonstrated the superiority of a preventive or curative treatment. Trolamine (Biafine®) is to date the only topic with a Marketing Authorization (MA) for the treatment of radiation-induced secondary erythema.

A study conducted on 254 patients at the Léon Bérard Center from 1999 to 2001 demonstrated that the preventive use of a calendula-based topical was associated with a statistically significant reduction of grade 2 radiodermitis compared to trolamine in patients presenting an early breast cancer treated with post-operative irradiation. However, this calendula ointment, which does not have the MA in the indicated indication, was in practice more difficult to apply than trolamine.

Currently, skin hygiene measures to be applied are systematically explained to patients before carrying out post-operative radiotherapy (cotton clothing, neutral soap, etc.). Some centers such as Center Léon Bérard recommend the systematic use of a topic after each session, while others recommend hygiene measures or implement other options (essential oils ...). However, the effectiveness of these current practices on the prevention of radiodermatitis has not yet been demonstrated.

It is a phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms Patients will be randomized (1 :1) in Arm A (hygiene measures + preventive treatment with Cicaderma ointment) or Arm B (preventive treatment according to the site recommendations (at least the hygiene measures) with a stratification (site, body mass index ≤25 vs \>25 and RT hypofractionning).

Randomized, multicentric Phase III study evaluating the Cicaderma ointment efficacy versus standard practice of each site in the prevention of radiodermatitis in patients presenting a non metastatic breast cancer

Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients

Randomised Multicentric Phase III Study Evaluating the Efficacy of Cicaderma vs Standard Management of Each Site in Preventing Radiodermatitis After Adjuvant Post-operative Breast Irradiation in Patients With Non-metastatic Breast Cancer

Number of patients presenting \>= 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

Patients' satisfaction evaluated using the "Patient's evaluation of the preventive management of radiodermatits" - Likert scale in 5 points (from very unsatisfied to very satisfied)

Patients' quality of life evaluated using the Dermatology Life Quality Index (DLQI) questionnaire (validated questionnaire composed of 10 items leading to a global score)

Patients' pain evaluated using a numeric scale from 0 (no pain) to 10 (unbearable pain)

Temporary or permanent radiotherapy interruption related to the onset of grade 3 radiodermatitis observed during patients' treatment period

Doses of radiation therapy received during each radiotherapy session

Onset of the first grade \>= 2 cutaneous event (radiodermatitis or prurit)

Compliance evaluated according to the ointment tubes brought back by the patients (not used or partially used) and patient's diary

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients	NCT04300829	Breast Adenocar... Radiation Derma... Radiation Toxic...	cicaderma + sim... Simple hygiene ...	18 Years -	Centre Leon Berard
Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients	NCT04300829	Breast Adenocar... Radiation Derma... Radiation Toxic...	cicaderma + sim... Simple hygiene ...	18 Years -	Centre Leon Berard

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