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Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT
BACKGROUND AND PURPOSE: To prevent the occurrence of grade ≥ 2 radiodermatitis after post-operative breast irradiation in patients with non metastatic breast cancer. METHODS: This prospective randomised open-label multicenter study allocated patients from 3 French institutions, ≥18 years, requiring...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10334129/ https://www.ncbi.nlm.nih.gov/pubmed/37441546 http://dx.doi.org/10.1016/j.ctro.2023.100647 |
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author | Racadot, Séverine Arnaud, Antoine Schiffler, Camille Metzger, Séverine Pérol, David Kirova, Youlia |
author_facet | Racadot, Séverine Arnaud, Antoine Schiffler, Camille Metzger, Séverine Pérol, David Kirova, Youlia |
author_sort | Racadot, Séverine |
collection | PubMed |
description | BACKGROUND AND PURPOSE: To prevent the occurrence of grade ≥ 2 radiodermatitis after post-operative breast irradiation in patients with non metastatic breast cancer. METHODS: This prospective randomised open-label multicenter study allocated patients from 3 French institutions, ≥18 years, requiring postoperative radiotherapy for histologically proven, early-stage (non-metastatic) unilateral breast adenocarcinoma or in situ breast cancer, with R0 or R1 post-operative status, to receive hygiene rules, associated with either Cicaderma® (Arm A), or preventive treatment according to the investigator preference (mainly hyaluronic acid (ialuset®), essential oils, or water spray, or no medication (Arm B). The primary outcome was to compare the efficacy of Cicaderma® versus local standard management in preventing the occurrence of grade ≥ 2 radiodermatitis. Main secondary objectives include Cicaderma® impact on radiotherapy discontinuation and on skin toxicity (pruritus), pain, quality of life, satisfaction. RESULTS: The CICA-RT study enrolled from June 2020 to April 2021, 258 women with a median age of 61 (22–91) years in 3 institutions. Patients received either Cicaderma® (A: N = 130) or standard practice (B: N = 128). In the 123 patients who initiated radiotherapy in each arm, 95 (77%, 95%CI 68.8%–84.3%) patients did not develop grade ≥ 2 dermatitis. Sensitivity and per-protocol analyses confirmed the absence of differences between arms. CONCLUSION: This prospective study did not meet its primary endpoint of superiority of Cicaderma® over routine practice skin care in terms of prevention of acute radioinduced dermatitis of grade 2 or higher. However, Cicaderma® showed a significant decrease in the occurrence of pruritus with less patients reporting at least once grade ≥ 2 pruritus (A: N = 38, 31%; B: N = 58, 47%; p = 0.009). ClinicalTrials.gov identifier NCT04300829. |
format | Online Article Text |
id | pubmed-10334129 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-103341292023-07-12 Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT Racadot, Séverine Arnaud, Antoine Schiffler, Camille Metzger, Séverine Pérol, David Kirova, Youlia Clin Transl Radiat Oncol Original Research Article BACKGROUND AND PURPOSE: To prevent the occurrence of grade ≥ 2 radiodermatitis after post-operative breast irradiation in patients with non metastatic breast cancer. METHODS: This prospective randomised open-label multicenter study allocated patients from 3 French institutions, ≥18 years, requiring postoperative radiotherapy for histologically proven, early-stage (non-metastatic) unilateral breast adenocarcinoma or in situ breast cancer, with R0 or R1 post-operative status, to receive hygiene rules, associated with either Cicaderma® (Arm A), or preventive treatment according to the investigator preference (mainly hyaluronic acid (ialuset®), essential oils, or water spray, or no medication (Arm B). The primary outcome was to compare the efficacy of Cicaderma® versus local standard management in preventing the occurrence of grade ≥ 2 radiodermatitis. Main secondary objectives include Cicaderma® impact on radiotherapy discontinuation and on skin toxicity (pruritus), pain, quality of life, satisfaction. RESULTS: The CICA-RT study enrolled from June 2020 to April 2021, 258 women with a median age of 61 (22–91) years in 3 institutions. Patients received either Cicaderma® (A: N = 130) or standard practice (B: N = 128). In the 123 patients who initiated radiotherapy in each arm, 95 (77%, 95%CI 68.8%–84.3%) patients did not develop grade ≥ 2 dermatitis. Sensitivity and per-protocol analyses confirmed the absence of differences between arms. CONCLUSION: This prospective study did not meet its primary endpoint of superiority of Cicaderma® over routine practice skin care in terms of prevention of acute radioinduced dermatitis of grade 2 or higher. However, Cicaderma® showed a significant decrease in the occurrence of pruritus with less patients reporting at least once grade ≥ 2 pruritus (A: N = 38, 31%; B: N = 58, 47%; p = 0.009). ClinicalTrials.gov identifier NCT04300829. Elsevier 2023-06-01 /pmc/articles/PMC10334129/ /pubmed/37441546 http://dx.doi.org/10.1016/j.ctro.2023.100647 Text en © 2023 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Original Research Article Racadot, Séverine Arnaud, Antoine Schiffler, Camille Metzger, Séverine Pérol, David Kirova, Youlia Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT |
title | Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT |
title_full | Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT |
title_fullStr | Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT |
title_full_unstemmed | Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT |
title_short | Cicaderma® in radiation–related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT |
title_sort | cicaderma® in radiation–related dermatitis of breast cancer: results from the multicentric randomised phase iii cica-rt |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10334129/ https://www.ncbi.nlm.nih.gov/pubmed/37441546 http://dx.doi.org/10.1016/j.ctro.2023.100647 |
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