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6007 : Phase II trial of high-dose melatonin oral gel for the prevention and treatment of oral mucositis in H&N cancer patients undergoing chemoradiation (MUCOMEL).

Researchers

Presenter

  • Alicia Lozano

Principal Investigators

  • Jordi Rubio-Casadevall

  • Nuria Farre

  • Antonio Lopez-Pousa

  • Jordi Giralt

  • Isabel Planas

  • Beatriz Cirauqui

  • M. Lanzuela

  • Rosa Morera

  • Ane Escribano

  • Jaime Gomez-Millan

  • Maria Dolores Toledo

  • Gonzalo Vazquez Masedo

  • Luis Cascallar

  • Pedro Grima

  • Vicente Valenti

  • Cristina Tarrago

  • Ramon Bosser

  • Ricard Mesia

Medical Centers

  • ICO Institut Catala d'Oncologia, Barcelona, Spain

  • Inst. Catala dOncologia Girona (SPA, Girona, Spain

  • Hospital Josep Trueta, Girona, Spain

  • Hospital Santa Creu i Sant Pau, Barcelona, Spain

  • Hospital De Sant Pau, Barcelona, Spain

  • Vall d'Hebron University Hospital, Barcelona, Spain

  • Institut Catala d'Oncologia Badalona-H U Germans Trias i Pujol, Badalona, Spain

  • Medical Oncology Department. Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Spain

  • Radiation Oncology Department, Miguel Servet University Hospital, Aragon Health Sciences Institute, Zaragoza, Spain

  • Hosp. Universitario La Paz, Madrid (SPA), Madrid, Spain

  • Hosp. Universitario Virgen de la Victoria, Malaga (SPA), Malaga, Spain

  • IBIMA-Hospital Regional Universitario y Virgen de la Victoria, Malaga, Spain

  • Hosp. Universitario Santiago de Compostela,, Santiago De Compostela, Spain

  • Spherium Biomed, S.L., Barcelona, Spain

  • Hospital Santa Tecla, Tarragona, Spain

  • Catalan Institute of Oncology, IDIBELL, Barcelona, Spain

Locations

  • Spain

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • N/A

Biomarkers

  • N/A

Drug/Treatment

  • Erbitux

  • Cisplatin

  • Melatonin

Outcome

  • N/A


Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Multicenteric

  • Prospective

  • Controlled

Phase

  • II

Study Id's

  • NCT02630004

Sponsors

  • N/A

Result

  • Final