An Exploratory, Randomised, Parallel Group Study, Comparing the Protective Effect of Soluble Beta-1,3/1,6-Glucan or Placebo in Oral Mucositis in Head and Neck Cancer Patients Receiving Radiation Therapy or Chemoradiotherapy
Sponsor study identifier
interventional
40
2 countries
3
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
The purpose of this study is to explore the protective effect and safety of soluble beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving radiotherapy or chemoradiotherapy. Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent oral mucositis
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 8, 2006
Actual (reported)February 9, 2006
Actual (reported)July 2006
Date type not reportedThis date has not been verified as actual or estimated.
To assess actual grade of mucositis upon completion of radiotherapy or chemoradiotherapy and after prophylactic treatment with soluble beta-1,3/1,6-glucan or placebo.
To assess proportions of patients avoiding grade 2 or higher oral mucositis after treatment with soluble beta-1,3/1,6-glucan or placebo
To assess time before first sign of oral mucositis
To evaluate impact of toxicities like patients' pain and swallowing difficulty
To assess the safety of the investigational product
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medical Centre Bonn, Clinic for Radiotherapy and Radiological Oncology
Bonn, 53119, Germany
Evangelisches Krankenhaus
Düsseldorf, 40217, Germany
Royal Marsden Hospital, Head and Neck Unit
London, SW3 6JJ, United Kingdom
Christopher M Nutting, Dr.med.
Royal Marsden NHS Foundation Trust
First Submitted
February 8, 2006
First Posted
February 9, 2006
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
July 2006
Date type not reportedSafety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
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This date has not been verified as actual or estimated.
Last Updated
January 17, 2007
Record last verified: 2006-05
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Source: ClinicalTrials.gov.
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