Prevention of Oral Mucositis and Improvement of Quality of Life for Patients With Breast Cancer Undergoing Adjuvant Radiotherapy

Summary

Breast cancer patients receiving adjuvant radiotherapy after surgery, particularly when the supraclavicular lymph nodes are included in the treatment area, frequently experience side effects of esophagitis such as sore throat, hoarseness, difficulty swallowing, and a reduction in white blood cell counts. Currently, no specific treatments exist to mitigate these adverse effects. This study proposes the use of alginate as a potential solution to alleviate these symptoms and improve the quality of life in breast cancer patients undergoing radiotherapy. Although the side effects of radiotherapy do not typically pose a clinical risk, they have a profound impact on patients' quality of life, particularly affecting nutrition intake and well-being. This study aims to evaluate whether alginate can prevent these radiotherapy-induced side effects and improve the overall quality of life for breast cancer patients. The trial will be conducted with 150 breast cancer patients undergoing adjuvant radiotherapy after surgery. The patients will receive 10cc of alginate orally, four times daily. Weekly evaluations will be conducted to assess the presence and improvement of symptoms such as sore throat, hoarseness, difficulty swallowing, and changes in white blood cell counts. Quality of life will be measured using the EORTC BR23 and QLQ-C30 questionnaires at the first and last sessions of radiation therapy. The study aims to determine whether alginate can effectively prevent the side effects of radiation therapy, such as oral inflammation, sore throat, hoarseness, difficulty swallowing, and a decrease in blood cell counts. Furthermore, it will evaluate whether these improvements lead to a better quality of life for breast cancer patients undergoing adjuvant radiotherapy.

Timeline

Start

2024-02-15

Primary completion

2026-12

Completion

2027-12

Publications

• Background West K, Schneider M, Wright C, Beldham-Collins R, Coburn N, Tiver K, Gebski V, Stuart KE. Radiation-induced oesophagitis in breast cancer: Factors influencing onset and severity for patients receiving supraclavicular nodal irradiation. J Med Imaging Radiat Oncol. 2020 Feb;64(1):113-119. doi: 10.1111/1754-9485.12943. Epub 2019 Sep 4.
• Background Upadhyay R, Bazan JG. Advances in Radiotherapy for Breast Cancer. Surg Oncol Clin N Am. 2023 Jul;32(3):515-536. doi: 10.1016/j.soc.2023.03.002.
• Background Weber WP, Hanson SE, Wong DE, Heidinger M, Montagna G, Cafferty FH, Kirby AM, Coles CE. Personalizing Locoregional Therapy in Patients With Breast Cancer in 2024: Tailoring Axillary Surgery, Escalating Lymphatic Surgery, and Implementing Evidence-Based Hypofractionated Radiotherapy. Am Soc Clin Oncol Educ Book. 2024 Jun;44(3):e438776. doi: 10.1200/EDBK_438776.
• Background Yu H, Lam KO, Green MD, Wu H, Yang L, Wang W, Jin J, Hu C, Wang Y, Jolly S, Spring Kong FM. Significance of radiation esophagitis: Conditional survival assessment in patients with non-small cell lung cancer. J Natl Cancer Cent. 2021 Feb 18;1(2):31-38. doi: 10.1016/j.jncc.2021.02.003. eCollection 2021 Jun.
• Background Saldi S, Perrucci E, Fulcheri CPL, Mariucci C, Chierchini S, Ingrosso G, Falcinelli L, Podlesko AM, Merluzzi M, Bini V, Aristei C. Zinc-L-carnosine prevented dysphagia in breast cancer patients undergoing adjuvant radiotherapy: Results of a phase III randomized trial. Breast J. 2020 Sep;26(9):1882-1884. doi: 10.1111/tbj.13855. Epub 2020 May 7. No abstract available.
• Background Fiets WE, van Helvoirt RP, Nortier JW, van der Tweel I, Struikmans H. Acute toxicity of concurrent adjuvant radiotherapy and chemotherapy (CMF or AC) in breast cancer patients. a prospective, comparative, non-randomised study. Eur J Cancer. 2003 May;39(8):1081-8. doi: 10.1016/s0959-8049(03)00178-3.
• Background Gay HA, Oh JH, Apte AP, Daly MD, Adkins DR, Rich J, Oppelt PJ, Dyk PT, Mullen DF, Eschen L, Chin RI, Nussenbaum B, Haughey BH, Thorstad WL, Deasy JO. Predictors of acute throat or esophageal patient reported pain during radiation therapy for head and neck cancer. Clin Transl Radiat Oncol. 2018 Sep 4;13:1-6. doi: 10.1016/j.ctro.2018.08.004. eCollection 2018 Nov.

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