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
Clin. transl. oncol. (Print)
; 23(9): 1801-1810, sept. 2021. ilus
Article
in English
| IBECS
| ID: ibc-222179
Responsible library:
ES1.1
Localization: ES15.1 - BNCS
ABSTRACT
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 (11 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint grade 34 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints SOM duration and grade 24 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 (AU)
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Collection:
National databases
/
Spain
Database:
IBECS
Main subject:
Stomatitis
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Cisplatin
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Cetuximab
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Head and Neck Neoplasms
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Melatonin
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Mouthwashes
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Antineoplastic Agents
Limits:
Adult
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Aged
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Female
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Humans
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Male
Language:
English
Journal:
Clin. transl. oncol. (Print)
Year:
2021
Document type:
Article
Institution/Affiliation country:
Campus de Teatinos/Spain
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Hospital Clínico San Carlos/Spain
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Hospital Durán I Reynals/Spain
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Hospital Germans Trias i Pujol/Spain
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Hospital Universitari Dr. Josep Trueta/Spain
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Hospital de la Santa Creu i Sant Pau/Spain
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Paseo Isabel la Católica/Spain
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Paseo de la Castellana/Spain