Melatonin Oral Gel for Oral Mucositis in Patients With Head and Neck Cancer Undergoing Chemoradiation

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.

Conditions

• Oral Mucositis

Interventions

DRUG

Melatonin oral gel 3%

DRUG

Placebo oral gel

Sponsors & Collaborators

• Institut Català d'Oncologia L'Hospitalet

  collaborator UNKNOWN

• Hospital Universitari de la Vall de Hebron

  collaborator UNKNOWN

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  collaborator OTHER

• Institut Català d'Oncologia ICO Girona

  collaborator UNKNOWN

• Institut Català d'Oncologia ICO Badalona

  collaborator UNKNOWN

• Hospital Miguel Servet

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital Universitario Virgen de la Victoria

  collaborator OTHER

• Hospital San Carlos, Madrid

  collaborator OTHER

• Hospital Clinico Universitario de Santiago

  collaborator OTHER

• Spherium Biomed

  lead INDUSTRY

Principal Investigators

• Alicia Lozano, MD · Institut Català d'Oncologia L'Hospitalet

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2017-12-31

Completion

2017-12-22

Countries

• Spain

Study Locations