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

This study has been completed.
Sponsor:
Information provided by:
Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:
NCT00790322
First received: November 11, 2008
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Head and Neck Cancer
Oral Mucositis
Drug: SBG
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Biotec Pharmacon ASA:

Primary Outcome Measures:
  • Compare the proportion of patients in the two arms who develop severe oral mucositis [ Time Frame: During radiation therapy ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790322

Locations
France
Institute Gustave Roussy
Villejuif Cédex, France, 94805
Sponsors and Collaborators
Biotec Pharmacon ASA
  More Information

No publications provided

Responsible Party: Vice President Clinical Development, Biotec Pharmacon ASA
ClinicalTrials.gov Identifier: NCT00790322     History of Changes
Other Study ID Numbers: SBG-2-03, EudraCT-number: 2008-002340-42
Study First Received: November 11, 2008
Last Updated: February 18, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines

Keywords provided by Biotec Pharmacon ASA:
Cancer
Radiation therapy
Radiotherapy
Oral Mucositis
SBG

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 01, 2014