Status:
COMPLETED
The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients
Lead Sponsor:
Biotec Pharmacon ASA
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chemor...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00289003
Start Date
October 1 2003
End Date
July 1 2006
Last Update
January 17 2007
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Centre Bonn, Clinic for Radiotherapy and Radiological Oncology
Bonn, Germany, 53119
2
Evangelisches Krankenhaus
Düsseldorf, Germany, 40217
3
Royal Marsden Hospital, Head and Neck Unit
London, United Kingdom, SW3 6JJ