Clinical trial · Interventional
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer
NCT01400620CI-TRIAL-00032051completedPhase 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 determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.
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 |
|---|---|---|---|
| IZN-6N4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active oral rinse
- description
- Oral rinse containing botanical extracts
- interventionNames
- Drug: IZN-6N4
- type
- PLACEBO_COMPARATOR
- label
- Placebo rinse
- interventionNames
- Drug: IZN-6N4
Primary outcomes (1)
- measure
- Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
- timeFrame
- Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of head and neck cancer * planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy * able to eat at least soft solids * normal cardiac function * able to perform oral rinse Exclusion Criteria: * Induction chemotherapy regimen * life threatening allergic reaction to food and/or drugs * history of any other primary malignancy diagnosed within the past 5 years * prior radiation to the sites to be treated * active infections of the oral cavity
References
Publications (0)
Data not yet available
No reference posted for this study.