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

NCT04300829 | Unknown Phase 3 DMC

• 1 other identifier: ET19-084 - CICA-RT
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 3

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)

Conditions

Breast Adenocarcinoma; Radiation Dermatitis; Radiation Toxicity

Keywords

Non-metastatic breast cancer; Post operative adjuvant radiotherapy; Radiotherapy cutaneous toxicity

Outcome Measures

Primary Outcomes (1)

• Comparison of the Cicaderma ointment efficacy versus the standard management of each site in preventing the onset of grade >= 2 radiodermatitis (NCI-CTCAE-V5)

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

  Up to 30+/-4 days after the end of radiotherapy interruption

Secondary Outcomes (10)

• Patients' satisfaction

  30+/-4 days after the end of radiotherapy interruption

• Patients' quality of life: DLQI questionnaire

  Up to 30+/-4 days after the end of radiotherapy interruption

• Patients' pain in the irradiated area: numeric scale

  Up to 30+/-4 days after the end of radiotherapy interruption

• Rate of temporary or permanent RT interruption related to the onset of grade 3 radiodermatitis

  Through radiotherapy completion, an average of 5 weeks

• Rate of prurit onset whatever the grade

  Up to 30+/-4 days after the end of radiotherapy interruption

Study Arms (2)

Simple hygiene rules of the site + Cicaderma ointment

EXPERIMENTAL

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)

Drug: cicaderma + simple hygiene rules

Preventive standard cares

ACTIVE COMPARATOR

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

Other: Simple hygiene rules and a maximum of one topical treatment

Interventions

cicaderma + simple hygiene rules DRUG

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

Also known as: Cicaderma ointment and simple hygiene rules

Simple hygiene rules of the site + Cicaderma ointment

Simple hygiene rules and a maximum of one topical treatment OTHER

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

Preventive standard cares

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (3)

Institut Sainte-Catherine

Avignon, 84000, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Institut Curie

Saint-Cloud, 92210, France

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 37441546 DERIVED

MeSH Terms

Conditions

Radiodermatitis; Radiation Injuries

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Séverine RACADOT, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

• Youlia KIROVA, MD PhD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Séverine METZGER

CONTACT

+33 4.78.78.27.86; severine.metzger@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 9, 2020
• Study Start: June 6, 2020
• Primary Completion: September 9, 2022
• Study Completion: October 9, 2022
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

FR (3)