Melatonin Oral Gel for Oral Mucositis in Patients With Head and Neck Cancer Undergoing Chemoradiation
Status:
Completed
Trial end date:
2017-12-22
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to assess the efficacy of melatonin oral gel compared to
placebo in the prevention and treatment of oral mucositis in patients with head and neck
cancer undergoing concurrent chemoradiation.
Other objectives are to assess the Quality of Life (QoL), to evaluate the safety and
tolerability and to assess the pharmacokinetic profile of melatonin oral gel administration,
in all cases compared to placebo in patients with head and neck cancer and oral mucositis
secondary to concurrent chemoradiation.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Spherium Biomed
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Hospital Clinico Universitario de Santiago Hospital Miguel Servet Hospital San Carlos, Madrid Hospital Universitari de la Vall de Hebron Hospital Universitario La Paz Hospital Universitario Marqués de Valdecilla Hospital Universitario Virgen de la Victoria Institut Català d'Oncologia ICO Badalona Institut Català d'Oncologia ICO Girona Institut Català d'Oncologia L'Hospitalet