drugset / Trial / NCT02630004
Melatonin Oral Gel for Oral Mucositis in Patients With Head and Neck Cancer Undergoing Chemoradiation
Phase 1/2
Completed
84 enrolled
Spherium Biomed
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · collabHospital Clinico Universitario de Santiago · collabHospital Miguel Servet · collabHospital San Carlos, Madrid · collabHospital Universitari de la Vall de Hebron · collabHospital Universitario La Paz · collabHospital Universitario Marqués de Valdecilla · collabHospital Universitario Virgen de la Victoria · collabInstitut Català d'Oncologia ICO Badalona · collabInstitut Català d'Oncologia ICO Girona · collabInstitut Català d'Oncologia L'Hospitalet · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2015-11
- Primary completion
- 2017-12
- Completion
- 2017-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 3 % | Oral |