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

This study has been completed.
Sponsor:
Information provided by:
Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:
NCT00289003
First received: February 8, 2006
Last updated: January 15, 2007
Last verified: May 2006
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Biotec Pharmacon ASA:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 40
Study Start Date: October 2003
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00289003

Locations
Germany
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
Investigators
Principal Investigator: Christopher M Nutting, Dr.med. Royal Marsden NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289003     History of Changes
Other Study ID Numbers: SMR-907-SBG-1-02-HN
Study First Received: February 8, 2006
Last Updated: January 15, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 September 16, 2014