Phase 3
Completed N=106
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
Radiotherapy Induced Mucositis · Head and Neck Cancer
Source: ClinicalTrials.gov NCT00615420 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment — 14; 18 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment |
14; 18 | — |
| PRIMARY Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments |
11; 16 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00615420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.