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
Por:
Lozano, A, Marruecos, J, Rubio, J, Farre, N, Gomez-Millan, J, Morera, R, Planas, I, Lanzuela, M, Vazquez-Masedo, MG, Cascallar, L, Giralt, J, Escames, G, Valenti, V, Grima, P, Bosser, R, Tarrago, C and Mesia, R
Publicada:
1 sep 2021
Ahead of Print:
1 mar 2021
Resumen:
Purpose 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. Methods 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. Results 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. Conclusions 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.
Filiaciones:
Lozano, A:
Hosp Duran I Reynals, Inst Catala Oncol ICO, Avda Granvia Hosp 199, Barcelona 08907, Spain
Marruecos, J:
Hosp Univ Dr Josep Trueta, Inst Catala Oncol ICO, Avda Franca S-N, Girona 17007, Spain
Rubio, J:
Hosp Univ Dr Josep Trueta, Inst Catala Oncol ICO, Avda Franca S-N, Girona 17007, Spain
Farre, N:
Hosp Santa Creu & Sant Pau, C St Quinti 89, Barcelona 08041, Spain
Gomez-Millan, J:
Hosp Univ Virgen de la Victoria, Campus Teatinos S-N, Malaga 29010, Spain
Morera, R:
Hosp Univ la Paz, Paseo Castellana 261, Madrid 28046, Spain
:
Hosp Badalona Germans Trias & Pujol, Inst Catala Oncol ICO, Carretera Canyet S-N, Barcelona 08916, Spain
Lanzuela, M:
Hosp Univ Miguel Servet, Paseo Isabel Catolica 1-3, Zaragoza 50009, Spain
Vazquez-Masedo, MG:
Hosp Clin San Carlos, C Prof Martin Lagos S-N, Madrid 28040, Spain
Cascallar, L:
CHUS, Hosp Clin Univ Santiago, Rua Choupana S-N, Santiago De Compostela 15706, A Coruna, Spain
Giralt, J:
Hosp Univ Vall dHebron, Passeig Vall dHebron 119, Barcelona 08035, Spain
Escames, G:
Univ Granada, Hlth Sci Technol Pk, Biomed Res Ctr, Granada Hosp Complex, Granada 18016, Spain
Univ Granada, CIBERFES, IBS, Dept Physiol, Granada Hosp Complex, Granada 18016, Spain
Valenti, V:
Hosp St Pau & Santa Tecla, C Rambla Vella 14, Tarragona 43003, Spain
Grima, P:
Ferrer Int SA, Ave Diagonal 549, Barcelona 08029, Spain
Bosser, R:
Spherium Biomed SLU, C Joan XXIII 10, Esplugas de Llobregat 08950, Spain
Tarrago, C:
Ferrer Int SA, Ave Diagonal 549, Barcelona 08029, Spain
Spherium Biomed SLU, C Joan XXIII 10, Esplugas de Llobregat 08950, Spain
:
Hosp Duran I Reynals, Inst Catala Oncol ICO, Avda Granvia Hosp 199, Barcelona 08907, Spain
Hosp Badalona Germans Trias & Pujol, Inst Catala Oncol ICO, Carretera Canyet S-N, Barcelona 08916, Spain
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