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

NCT ID: NCT04300829

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-06
• Study Completion Date: 2022-10-09

Brief Summary

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)

Detailed Description

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).

Conditions

Breast Adenocarcinoma; Radiation Dermatitis; Radiation Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simple hygiene rules of the site + Cicaderma ointment

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)

Group Type: EXPERIMENTAL

cicaderma + simple hygiene rules

Intervention Type: DRUG

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

Preventive standard cares

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

Group Type: ACTIVE_COMPARATOR

Simple hygiene rules and a maximum of one topical treatment

Intervention Type: OTHER

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

Interventions

cicaderma + simple hygiene rules

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

Intervention Type: DRUG

Simple hygiene rules and a maximum of one topical treatment

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

Intervention Type: OTHER

Other Intervention Names

Cicaderma ointment and simple hygiene rules

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Patient requiring a post-operative radiotherapy (post mastectomy or tumorectomy) for a mammary adenocarcinoma or an unilateral in situ breast cancer histologically documented, early stage of disease (non metastatic)
• Patient with no residual tumor (R0 or R1)
• Patient informed and having given her signed consent
• Patient affiliated to a social security regimen

Exclusion Criteria

• Unsolved cutaneous toxicities of any previous treatment
• Hormonotherapy started prior to radiotherapy
• Concomitant use of other topical treatments than the study treatments on the irradiated area
• Patient treated by concomitant chemotherapy and/or targeted therapy
• Known hypersensibility to at least one component of the topicals used or Cicadema ointment
• Patient for whom follow-up does not seem possible even in the short term
• Pregnant or breastfeeding woman
• Participation in another clinical trial that may interfere with the evaluation of the primary endpoint
• Patient Under tutorship or curatorship or deprived of liberty

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Séverine RACADOT, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Youlia KIROVA, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Institut Sainte-Catherine

Avignon, , France

Site Status: RECRUITING

Institut Curie

Paris, , France

Site Status: RECRUITING

Institut Curie

Saint-Cloud, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Séverine METZGER

Role: CONTACT

severine.metzger@lyon.unicancer.fr

+33 4.78.78.27.86

Facility Contacts

Youlia KIROVA, MD PhD

Role: primary

youlia.kirova@curie.fr

Youlia KIROVA, MD

Role: primary

youlia.kirova@curie.fr

References

Racadot S, Arnaud A, Schiffler C, Metzger S, Perol D, Kirova Y. Cicaderma(R) in radiation-related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT. Clin Transl Radiat Oncol. 2023 Jun 1;41:100647. doi: 10.1016/j.ctro.2023.100647. eCollection 2023 Jul.

Reference Type: DERIVED

PMID: 37441546 (View on PubMed)

Other Identifiers

ET19-084 - CICA-RT

Identifier Type: -

Identifier Source: org_study_id