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Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790322
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : February 19, 2010
Sponsor:
Information provided by:
Biotec Pharmacon ASA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Mucositis Drug: SBG Other: Placebo Phase 3

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 therapy with or without chemotherapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Drug: SBG
Soluble beta-1,3/1,6-glucan is a solution for oral use
Placebo Comparator: Placebo Other: Placebo
Solution for oral use


Outcome Measures
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Primary Outcome Measures :
  1. Compare the proportion of patients in the two arms who develop severe oral mucositis [ Time Frame: During radiation therapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790322


Locations
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France
Institute Gustave Roussy
Villejuif Cédex, France, 94805
Sponsors and Collaborators
Biotec Pharmacon ASA
More Information
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Responsible Party: Vice President Clinical Development, Biotec Pharmacon ASA
ClinicalTrials.gov Identifier: NCT00790322    
Other Study ID Numbers: SBG-2-03
EudraCT-number: 2008-002340-42
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: February 19, 2010
Last Verified: February 2010
Keywords provided by Biotec Pharmacon ASA:
Cancer
Radiation therapy
Radiotherapy
Oral Mucositis
SBG
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases