S244
Clinical - Breast
ESTRO 2026
Conclusion: CPAP-assisted RT significantly reduces radiation exposure to the heart, selected cardiac substructures, and the lungs, while remaining well tolerated. Although overall mean dose reductions were small (<1 Gy), a subset of patients experienced more substantial individual benefit. Ongoing enrollment and analyses will determine which patients derive clinically meaningful advantage from CPAP-assisted RT to support future selection models and clinical guidelines. References: 1. Choi MS et al. Adv Radiat Oncol 2024; 9:101478.2. Allen AM et al. Radiat Oncol 2020. 3. Reckhow J et al. Med Dosim 2021; 46:127–131. Keywords: Continuous Positive Airway Pressure, Dosimetry Translational Development and Clinical Validation of a First-in-Class Water-Soluble Atelocollagen Biomaterial for Radiotherapy-Induced Skin Damage. Despoina Kokkinidou 1 , Constantina Cloconi 2 , Anna Katsioloudi 3 , Demetra Wiedl 4 , Georghiou Danae 4 , Maria Kyprianidou 5 , Eleftheria Sidira 1 , Zenia Xenou 4 , Antria Savva 2 , Konstantinos Ferentinos 2 , Anna Christofini 1 , Konstantinos Kapnisis 6 , Andreas Anayiotos 6 , Costas Pitsillides 4 , Angelos Kassianos 5 , Constantinos Zamboglou 2 , Marianna Prokopi 1 1 R&D, RSL Revolutionary Labs Ltd, LIMASSOL, Cyprus. 2 RADIATION ONCOLOGY DEPARTMENT, German Medical Institute, LIMASSOL, Cyprus. 3 R&D, THERAMIR LTD, LIMASSOL, Cyprus. 4 R&D, Promed Bioscience Ltd, LIMASSOL, Cyprus. 5 Department of Nursing, Cyprus University of Technology, LIMASSOL, Cyprus. 6 Department of Mechanical Engineering and Materials Science and Engineering, Cyprus University of Technology, LIMASSOL, Cyprus Purpose/Objective: Radiotherapy-induced skin toxicity remains one of the most frequent and distressing side effects in breast cancer management, with limited clinically validated prophylactic interventions. Innovative dermaceutical products are therefore essential to address Digital Poster 1548 dermatological complications and improve patient outcomes during and after treatment. This study presents the translational development of a first-in- class water-soluble atelocollagen biomaterial designed to support skin integrity during radiotherapy. A proprietary medical-grade atelocollagen cream (ATC) was formulated and systematically evaluated through in vitro, ex vivo, and clinical studies to assess its biocompatibility, regenerative capacity, and
therapeutic benefit in preventing and mitigating radiation dermatitis Material/Methods: Atelocollagen was isolated from porcine tendons via pepsin digestion, followed by enzymatic-thermal processing to reduce antigenicity while maintaining triple-helical structure. The resultant mixture of water- soluble complex ( ≤ 120 kDa) underwent physicochemical and mechanical characterization, including SDS-PAGE, amino acid analysis, scanning electron microscopy, atomic force microscopy, viscosity testing, swelling analysis, solubility assessment, and contact angle measurements. ATC formulation incorporated atelocollagen, hyaluronic acid, and natural extracts, and was evaluated for microbiological safety, stability, and EU regulatory compliance. Biological performance was investigated through MTT cytotoxicity, OECD-439 skin irritation, fibroblast scratch-wound assay, hemolysis, eye irritation, and tumorigenicity screening. Gene and protein expression were quantified via qPCR and western blotting. A prospective clinical study (Clin.Trial ID: NCT05588973) beginning one day prior to the initiation of radiation therapy and continued throughout the treatment period. Skin reactions were assessed using CTCAE grading, photography, clinician scoring, and patient-reported outcomes (Skindex-17 and EORTC QLQ-C30). Statistical analysis employed ANOVA (p<0.05). Results: Atelocollagen demonstrated preserved structural integrity, hydrophilicity, and favorable viscoelastic behavior. ATC showed high biocompatibility (>90% fibroblast viability, no irritant or hemolytic responses). Molecular analysis revealed increased expression of collagen I, collagen III, and elastin. In vitro and ex vivo data confirmed accelerated wound closure, enhanced fibroblast migration, and improved matrix deposition. Clinically, patients using ATC experienced reduced incidence and severity of acute radiation dermatitis, faster resolution of Grade I–II lesions, and visible reduction in erythema, edema, and hyperpigmentation compared to standard care. Patient-reported measures showed improved comfort and reduced symptom burden. Conclusion: This comprehensive translational program demonstrates that early application of a water-soluble atelocollagen cream safely supports skin integrity, reduces radiotherapy-induced damage, and accelerates recovery in breast cancer patients. Findings support ATC as a promising dermaceutical candidate for quality-of-life enhancement in oncology
care, warranting broader clinical validation. Keywords: radiodermatitis, breast cancer
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