A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Assess the Efficacy and Safety of SBG on Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy With or Without Chemotherapy
18 Years
N/A
Both
Head and Neck Cancer, Oral Mucositis
Trial Information
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Assess the Efficacy and Safety of SBG on Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy With or Without Chemotherapy
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 therapy with or without chemotherapy.
Inclusion Criteria
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Compare the proportion of patients in the two arms who develop severe oral mucositis
Outcome Time Frame:
During radiation therapy
Safety Issue:
No
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
SBG-2-03
NCT ID:
NCT00790322
Start Date:
October 2008
Completion Date:
February 2010
Related Keywords:
- Head and Neck Cancer
- Oral Mucositis
- Cancer
- Radiation therapy
- Radiotherapy
- Oral Mucositis
- SBG
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
Name | Location |
|---|
