Clinical trial · Interventional
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
NCT00901732CI-TRIAL-00002306unknownPhase 1 / Phase 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)
Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.
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 |
|---|---|---|---|
| Caphosol | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol.
- timeFrame
- 15 weeks
Secondary outcomes (1)
- measure
- The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)
- timeFrame
- 15 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed Head and Neck Cancer patients with planned Radiation therapy * Have at least one of 10 pre-defined anatomic mucosal subsites on view * Age \>/= 18 years * Life expectancy \>/= 6 months * Planned RT to the head/neck * Must be able to perform oral rinse Exclusion Criteria: * Active infections of oral cavity * physiologic condition that precludes the use of an oral rinse * Hypersensitivity to Caphosol ingredients * Presence of mucosal ulceration at baseline * Poorly controlled hypertension, DM or other serious medical/psychiatric illness
References
Publications (0)
Data not yet available
No reference posted for this study.