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Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment.

Authors
  • Lozano, A1
  • Marruecos, J2
  • Rubió, J2
  • Farré, N3
  • Gómez-Millán, J4
  • Morera, R5
  • Planas, I6
  • Lanzuela, M7
  • Vázquez-Masedo, M G8
  • Cascallar, L9
  • Giralt, J10
  • Escames, G11, 12
  • Valentí, V13
  • Grima, P14
  • Bosser, R15
  • Tarragó, C14, 15
  • Mesía, R16, 6
  • 1 Institut Català d'Oncologia (ICO), Hospital Durán I Reynals, Avda de la Granvia de l'Hospitalet, 199, L'Hospitalet, 08907, Barcelona, Spain. [email protected] , (Spain)
  • 2 Institut Català d'Oncologia (ICO), Hospital Universitari Dr. Josep Trueta, Avda França s/n, 17007, Girona, Spain. , (Spain)
  • 3 Hospital de la Santa Creu i Sant Pau, C/Sant Quintí, 89, 08041, Barcelona, Spain. , (Spain)
  • 4 Hospital Universitario Virgen de la Victoria, Campus de Teatinos, s/n, 29010, Málaga, Spain. , (Spain)
  • 5 Hospital Universitario la Paz, Paseo de la Castellana, 261, 28046, Madrid, Spain. , (Spain)
  • 6 Institut Català d'Oncologia (ICO), Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916, Barcelona, Spain. , (Spain)
  • 7 Hospital Universitario Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain. , (Spain)
  • 8 Hospital Clínico San Carlos, C/Profesor Martín Lagos, s/n, 28040, Madrid, Spain. , (Spain)
  • 9 Hospital Clínico Universitario de Santiago, CHUS, Rúa da Choupana, s/n, Santiago de Compostela, 15706, A Coruña, Spain. , (Spain)
  • 10 Hospital Universitari de la Vall d'Hebron, Passeig de la Vall d'Hebron, 119, 08035, Barcelona, Spain. , (Spain)
  • 11 Biomedical Research Center, Health Sciences Technology Park, University of Granada, Granada Hospital Complex, 18016, Granada, Spain. , (Spain)
  • 12 Department of Physiology, University of Granada, CIBERFES, IBS, Granada Hospital Complex, 18016, Granada, Spain. , (Spain)
  • 13 Hospital de Sant Pau i Santa Tecla, C/ Rambla Vella, 14, 43003, Tarragona, Spain. , (Spain)
  • 14 Ferrer Internacional SA, Avenida Diagonal, 549, 08029, Barcelona, Spain. , (Spain)
  • 15 Spherium Biomed, S.L.U., C/ Joan XXIII, 10, 08950, Esplugues de Llobregat, Spain. , (Spain)
  • 16 Institut Català d'Oncologia (ICO), Hospital Durán I Reynals, Avda de la Granvia de l'Hospitalet, 199, L'Hospitalet, 08907, Barcelona, Spain. , (Spain)
Type
Published Article
Journal
Clinical & Translational Oncology
Publisher
Springer-Verlag
Publication Date
Sep 01, 2021
Volume
23
Issue
9
Pages
1801–1810
Identifiers
DOI: 10.1007/s12094-021-02586-w
PMID: 33738704
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer. Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3-4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2-4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration. Eighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms. Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial. © 2021. Federación de Sociedades Españolas de Oncología (FESEO).

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