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

Sponsor:	Biotec Pharmacon ASA
Information provided by:	Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:	NCT00289003

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

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

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

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

Additional relevant MeSH terms:

Mouth Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomatitis

Mucositis
Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010