Status:
COMPLETED
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Radiotherapy Induced Mucositis
Head and Neck Cancer
Eligibility:
All Genders
Phase:
PHASE3
Brief 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...
Detailed Description
Oral mucositis is a common side-effect of radiation therapy for many head and neck cancers, and can have a very severe impact on quality of life and nutritional status. At least42% of patients treated...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00615420
Start Date
July 1 2008
End Date
October 1 2011
Last Update
June 5 2019
Active Locations (2)
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1
BC Cancer Agency
Surrey, British Columbia, Canada
2
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6