Clinical trial · Interventional
The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients
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
NCT00289003CI-TRIAL-00000563completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Soluble beta-1,3/1,6-glucan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (4)
- measure
- To assess proportions of patients avoiding grade 2 or higher oral mucositis after treatment with soluble beta-1,3/1,6-glucan or placebo
- measure
- To assess time before first sign of oral mucositis
- measure
- To evaluate impact of toxicities like patients' pain and swallowing difficulty
- measure
- To assess the safety of the investigational product
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.