NCT01941992

Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients

Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: * evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy. * assess tolerability of SAMITAL and the impact on patients reported outcomes.

Conditions

• Head-and-neck Squamous Cell Carcinoma
• Oral Mucositis

Interventions

Type	Name	Description
DRUG	SAMITAL®
DRUG	Placebo sachets

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-12-01
• Completion: 2018-01-01
• First posted: 2013-09-13
• Last updated: 2018-09-13

Locations

1 site across 1 country: Italy