Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.

Summary

This study is a Phase 2, double-blind, randomized controlled trial evaluating the safety and efficacy of TV5M01 (a 5% green tea and 0.1% morphine gel) compared to triple mixture (0.19% lidocaine, 0.29% nystatin, and 5.50% hydroxides) for treating radiation-induced oral mucositis in patients with head and neck squamous cell carcinoma. The trial will enroll 40 patients (20 per group) with stage III-IV head and neck cancer receiving radiotherapy who develop grade 1 or higher mucositis. Participants will apply the assigned mouthwash three times daily from mucositis diagnosis until resolution. Primary outcomes include safety (incidence of infections and adverse events) and efficacy (duration of grade 3-4 mucositis, days with severe pain). Secondary outcomes include quality of life and analgesic use. Randomization will use minimization methodology to balance important prognostic factors. The study design incorporates two interim analyses after 10 and 19 participants, with clear safety monitoring and stopping rules. If successful, this trial could provide an evidence-based treatment option for radiotherapy-induced mucositis, potentially improving treatment completion rates and quality of life for head and neck cancer patients.

Timeline

Start

2025-12-28

Primary completion

2026-12-31

Completion

2026-12-31

Publications

• Background Rosati M, Bramante S, Conti F, Frattari A, Rizzi M, Roman RA. Operative Gynecological Laparoscopy Under Conscious Sedation. JSLS. 2020 Apr-Jun;24(2):e2020.00020. doi: 10.4293/JSLS.2020.00020.
• Background Liu YP, He RX, Chen ZH, Kang LL, Song JQ, Liu Y, Shi CY, Chen JY, Dong H, Zhang Y, Li MQ, Jin Y, Qin J, Yang YL. Case report: An asymptomatic mother with an inborn error of cobalamin metabolism (cblC) detected through high homocysteine levels during prenatal diagnosis. Front Nutr. 2023 May 12;10:1124387. doi: 10.3389/fnut.2023.1124387. eCollection 2023.
• Background Gramegna A, Amati F, Terranova L, Sotgiu G, Tarsia P, Miglietta D, Calderazzo MA, Aliberti S, Blasi F. Neutrophil elastase in bronchiectasis. Respir Res. 2017 Dec 19;18(1):211. doi: 10.1186/s12931-017-0691-x.
• Background Mourad R, Kolisnyk S, Baiun Y, Falk A, Yuriy T, Valerii F, Kopeev A, Suldina O, Pospelov A, Kim J, Rusakov A, Lebl DR. Performance of hybrid artificial intelligence in determining candidacy for lumbar stenosis surgery. Eur Spine J. 2022 Aug;31(8):2149-2155. doi: 10.1007/s00586-022-07307-7. Epub 2022 Jul 8.
• Background Oit-Wiscombe I, Virag L, Soomets U, Altraja A. Increased DNA damage in progression of COPD: a response by poly(ADP-ribose) polymerase-1. PLoS One. 2013 Jul 24;8(7):e70333. doi: 10.1371/journal.pone.0070333. Print 2013.
• Background Skeie EJ, Borge JA, Leboeuf-Yde C, Bolton J, Wedderkopp N. Reliability of diagnostic ultrasound in measuring the multifidus muscle. Chiropr Man Therap. 2015 Apr 15;23:15. doi: 10.1186/s12998-015-0059-6. eCollection 2015.
• Background Cerchietti LC, Navigante AH, Bonomi MR, Zaderajko MA, Menendez PR, Pogany CE, Roth BM. Effect of topical morphine for mucositis-associated pain following concomitant chemoradiotherapy for head and neck carcinoma. Cancer. 2002 Nov 15;95(10):2230-6. doi: 10.1002/cncr.10938.
• Background Zhu W, Mei H, Jia L, Zhao H, Li X, Meng X, Zhao X, Xing L, Yu J. Epigallocatechin-3-gallate mouthwash protects mucosa from radiation-induced mucositis in head and neck cancer patients: a prospective, non-randomised, phase 1 trial. Invest New Drugs. 2020 Aug;38(4):1129-1136. doi: 10.1007/s10637-019-00871-8. Epub 2019 Nov 7.

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