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The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients

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. Identifier: NCT00289003
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : January 17, 2007
Information provided by:
Biotec Pharmacon ASA

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Oral Mucositis Drug: Soluble beta-1,3/1,6-glucan Phase 2

Detailed Description:

Oral mucositis is defined as inflammation and ulceration of the mucous membranes of the mouth. The condition is very painful and might put the patient at risk of serious systemic infections and is a common dose-limiting toxicity of chemotherapy and radiotherapy. The present treatment of mucositis is primarily supportive; strong analgesics in addition to oral hygiene. Prophylactic antibiotics have been used and many topical agents are available to palliate mucositis, but no standard therapy has been accepted.

Comparison: Methyl cellulose has been chosen as placebo due to its close resemblance to soluble beta-1,3/1,6-glucan in terms of general appearance and viscosity. Methyl cellulose is a viscous solution which might form a mucosal barrier. Physical barriers are considered having a protective function in oral mucositis, and methyl cellulose might be considered as an active control.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2003
Study Completion Date : July 2006

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. To assess proportions of patients avoiding grade 2 or higher oral mucositis after treatment with soluble beta-1,3/1,6-glucan or placebo
  2. To assess time before first sign of oral mucositis
  3. To evaluate impact of toxicities like patients' pain and swallowing difficulty
  4. To assess the safety of the investigational product

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing radiotherapy or chemoradiotherapy for histologically confirmed squamous cell carcinoma of oral cavity or oropharynx (1.8-2.0 Gy/day; 5 days per week, totally 59.4-70 Gy).
  • Normal mucosa at baseline (i.e. Common Toxicity Criteria (CTC) grade 0)
  • >= 18 years of age
  • Women of childbearing potential must use an adequate contraceptive method and have a negative pregnancy test
  • Written informed consent

Exclusion Criteria:

  • Patients who will receive hyperfractionated or accelerated radiotherapy
  • History of malignancies within the past five years other than non-melanomatous skin cancers (with the exception of squamous cell carcinoma of the skin) or carcinoma in situ of the cervix
  • Previous neoplasm in the head and neck area, whether malignant or not
  • Previous radiation therapy for head and neck cancer
  • If wound from curative surgery have not healed
  • Patients expected to receive agents that would interfere with the investigator's ability to assess changes in the appearance of the mucositis during the study
  • Use of radiosensitizers
  • History or clinical evidence of active significant acute or chronic diseases that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis
  • Evidence of distant metastatic disease
  • Expected survival of less than 12 months
  • > grade 3 performance status (WHO grading)
  • Granulocyte count < 2.000/mm3 and platelet count < 100,000/mm3
  • Serum creatinine >= 150 micromol/L
  • Total bilirubin >= 36 micromol/L, AST > 3 times the upper normal limit
  • Any subject who, in the opinion of the investigator, is unlikely to comply with the study procedures, or is unlikely to complete the study due to different reasons like e.g. language barriers or mental incapacity
  • Participation in a clinical trial in the last 30 days Receipt of any investigational product within 30 days prior to this trial

Information from the National Library of Medicine

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 identifier (NCT number): NCT00289003

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Medical Centre Bonn, Clinic for Radiotherapy and Radiological Oncology
Bonn, Germany, 53119
Evangelisches Krankenhaus
Düsseldorf, Germany, 40217
United Kingdom
Royal Marsden Hospital, Head and Neck Unit
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Biotec Pharmacon ASA
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Principal Investigator: Christopher M Nutting, Royal Marsden NHS Foundation Trust
Layout table for additonal information Identifier: NCT00289003    
Other Study ID Numbers: SMR-907-SBG-1-02-HN
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: May 2006
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases