Clinical trial · Interventional
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Assess the Efficacy and Safety of SBG on Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy With or Without Chemotherapy
NCT00790322CI-TRIAL-00003166completedPhase 3ClinicalTrials.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 evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| SBG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active
- interventionNames
- Drug: SBG
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Compare the proportion of patients in the two arms who develop severe oral mucositis
- timeFrame
- During radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study. * Patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.