Efficacy and Safety of Qibei Jiedu Formula for Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients

Summary

1. To evaluate the preventive and therapeutic effects of Qibei Jiedu Formula on acute radiation dermatitis in breast cancer patients, including the incidence of grade 2 or higher radiation dermatitis, wound healing time, and symptom relief. 2. To observe the safety profile of Qibei Jiedu Formula. 3. To investigate the potential role of Qibei Jiedu Formula in improving patients' quality of life. 4. To explore the potential mechanism of action of Qibei Jiedu Formula in preventing and treating acute radiation dermatitis in breast cancer patients through exploratory indicators such as inflammatory cytokines and skin microbiota. 5. This study is a small-scale exploratory clinical trial. It aims to collect preliminary efficacy and safety data from 60 participants to assess the "add-on effect" of Qibei Jiedu Formula on top of "standard basic care". The results are intended for estimating effect sizes and generating hypotheses to inform future large-scale studies, not for drawing definitive conclusions.

Timeline

Start

2026-01-27

Primary completion

2026-11-30

Completion

2026-12-31

Publications

• Background Schmeel LC, Koch D, Schmeel FC, Bucheler B, Leitzen C, Mahlmann B, Kunze D, Heimann M, Bruser D, Abramian AV, Schoroth F, Mudder T, Rohner F, Garbe S, Baumert BG, Schild HH, Wilhelm-Buchstab TM. Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment. Polymers (Basel). 2019 Dec 16;11(12):2112. doi: 10.3390/polym11122112.
• Background Bohner AMC, Koch D, Schmeel FC, Rohner F, Schoroth F, Sarria GR, Abramian AV, Baumert BG, Giordano FA, Schmeel LC. Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric L*a*b Color-Space. Cancers (Basel). 2020 Aug 28;12(9):2444. doi: 10.3390/cancers12092444.
• Background Dejonckheere CS, Layer JP, Sarria GR, Wiegreffe S, Glasmacher AR, Nour Y, Scafa D, Mudder T, Anzbock T, Giordano FA, Stope MB, Schmeel LC, Gkika E. Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: study protocol for a phase 3 randomised double-blind placebo-controlled trial (NIPP-RD III). Trials. 2025 Mar 19;26(1):97. doi: 10.1186/s13063-025-08806-w.
• Background Tang Y, Zhou Y, Li HJ. Advances in mesenchymal stem cell exosomes: a review. Stem Cell Res Ther. 2021 Jan 19;12(1):71. doi: 10.1186/s13287-021-02138-7.
• Background Wickenheisser VA, Zywot EM, Rabjohns EM, Lee HH, Lawrence DS, Tarrant TK. Laser Light Therapy in Inflammatory, Musculoskeletal, and Autoimmune Disease. Curr Allergy Asthma Rep. 2019 Jul 2;19(8):37. doi: 10.1007/s11882-019-0869-z.
• Background Hong JP, Lee SW, Song SY, Ahn SD, Shin SS, Choi EK, Kim JH. Recombinant human epidermal growth factor treatment of radiation-induced severe oral mucositis in patients with head and neck malignancies. Eur J Cancer Care (Engl). 2009 Nov;18(6):636-41. doi: 10.1111/j.1365-2354.2008.00971.x. Epub 2009 Apr 23.
• Background Liu C, Wei J, Wang X, Zhao Q, Lv J, Tan Z, Xin Y, Jiang X. Radiation-induced skin reactions: oxidative damage mechanism and antioxidant protection. Front Cell Dev Biol. 2024 Oct 9;12:1480571. doi: 10.3389/fcell.2024.1480571. eCollection 2024.
• Background Rube CE, Freyter BM, Tewary G, Roemer K, Hecht M, Rube C. Radiation Dermatitis: Radiation-Induced Effects on the Structural and Immunological Barrier Function of the Epidermis. Int J Mol Sci. 2024 Mar 15;25(6):3320. doi: 10.3390/ijms25063320.
• Background Xie Y, Wang Q, Hu T, Chen R, Wang J, Chang H, Cheng J. Risk Factors Related to Acute Radiation Dermatitis in Breast Cancer Patients After Radiotherapy: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Nov 29;11:738851. doi: 10.3389/fonc.2021.738851. eCollection 2021.
• Background Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
• Background Giaquinto AN, Sung H, Miller KD, Kramer JL, Newman LA, Minihan A, Jemal A, Siegel RL. Breast Cancer Statistics, 2022. CA Cancer J Clin. 2022 Nov;72(6):524-541. doi: 10.3322/caac.21754. Epub 2022 Oct 3.

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