Phase 3 N=106 Randomized Quadruple-blind Supportive Care

A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer

Radiotherapy Induced Mucositis · Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00615420 ↗

Enrolled (actual)

106

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment — 14; 18 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: manuka honey (Dietary_supplement); placebo gel (Dietary_supplement)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: British Columbia Cancer Agency
Primary completion: Oct 2011

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	—

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.

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

View full record on ClinicalTrials.gov →

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.