Clinical trial · Interventional
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
NCT00615420CI-TRIAL-00038956completedPhase 3Results postedClinicalTrials.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 primary hypothesis of this study is that regular topical oral application of Manuka Honey will reduce the severity and duration of oral mucositis in patients who are undergoing mucotoxic radiation therapy for cancer treatment.
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 |
| Radiotherapy Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| manuka honey | Dietary Supplement | — | UNRESOLVED |
| placebo gel | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Manuka Honey
- description
- Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
- interventionNames
- Dietary Supplement: manuka honey
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed
- interventionNames
- Dietary Supplement: placebo gel
Primary outcomes (2)
- measure
- Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients commencing radiation therapy of 50 Gy or higher with the dosage field affecting the oral mucosa unilaterally or bilaterally (minimum 3 observable sites affected). * Patients willing and able to attend weekly assessments throughout their treatment, plus one week after completion of treatment. Exclusion Criteria: * Patients unable to understand the consent process (translators will be used if necessary so being English-speaking is not required). * Patients unable to attend the follow-up visits * Patients participating in other clinical trials which might affect the severity of mucositis * Patients allergic to honey, multiple pollens, or to celery
References
Publications (0)
Data not yet available
No reference posted for this study.