Clinical trial · Interventional
Safety of Phenylephrine for Oral Mucositis Prevention
A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes
NCT01092975CI-TRIAL-00049147terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): formulation/dose changes; planned changes to safety monitoring/reporting
Summary
Brief summary (as posted)
The purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes.
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 |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| phenylephrine solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- 1.25 mg phenylephrine
- interventionNames
- Drug: phenylephrine solution
- type
- EXPERIMENTAL
- label
- 2.5 mg phenylephrine
- interventionNames
- Drug: phenylephrine solution
- type
- EXPERIMENTAL
- label
- 5.0 mg phenylephrine
- interventionNames
- Drug: phenylephrine solution
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes * normal ECG * normal blood pressure Exclusion Criteria: * untreated cardiac disease * connective tissue disorders * open sores, wound, ulcerations to oral cavity * allergy to phenylephrine * know untreated hypertensin * abnormal ECG in past 6 months * taking prescription monoamine oxidase inhibitor (MAOI) * are pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.