Status:
COMPLETED
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
Lead Sponsor:
Biotec Pharmacon ASA
Conditions:
Head and Neck Cancer
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.
Detailed Description
The objective of the study is to evaluate the efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on oral mucositis compared to placebo in head and neck cancer patients undergoing radiation thera...
Eligibility Criteria
Inclusion
- Patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study.
- Patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00790322
Start Date
October 1 2008
End Date
February 1 2010
Last Update
February 19 2010
Active Locations (1)
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1
Institute Gustave Roussy
Villejuif Cédex, France, 94805