- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00615420
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
Study Overview
Status
Intervention / Treatment
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 for head and neck cancers will develop grade 3 or 4 oral mucositis. Although there have been positive trials, no study has had overwhelming data to strongly support any one agent in the prevention or treatment of oral mucositis. A comprehensive review of the literature done in 2004 found only benzydamine (a topical nonsteroidal anti-inflammatory agent) to be beneficial as a palliative treatment for established mucositis. Management essentially consists of pain management, with topical and oral analgesics/anaesthetics and anti-inflammatory agents, and nutritional support, once mucositis is established. Despite the use of these agents, many patients still have severe mucositis, and there is great need for new treatments to reduce this distressing complication of cancer therapy.
Currently, the only standard "treatment" consists of an oral rinse of warm water, salt, and baking soda 4 times a day. This is only to maintain oral hygiene and does not have any impact on the severity or duration of the mucositis itself. Topical fluoride is applied at bedtime to reduce the caries risk. Basic oral care (brushing and flossing as tolerated) is recommended to maintain general mucosal health and to reduce the impact of oral microbial flora.
Study Objectives The primary objective of this study is to see if topical oral Manuka honey reduces the severity of mucositis in patients receiving radiation treatment for head and neck cancer. Secondary objectives are to assess the impact of any demonstrated improvement in mucositis on nutrition, symptom burden, quality of life, and radiotherapy treatment interruptions.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
British Columbia
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Surrey, British Columbia, Canada
- BC Cancer Agency
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manuka Honey
Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
|
Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed.
May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
|
Placebo Comparator: Placebo
Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed
|
Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed.
May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment
Time Frame: Over 7 weeks of expected duration of mucositis
|
Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.
|
Over 7 weeks of expected duration of mucositis
|
Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments
Time Frame: Over 7 weeks of expected duration of mucositis
|
Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.
|
Over 7 weeks of expected duration of mucositis
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippa Hawley, B.Med, British Columbia Cancer Agency
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H07-02297
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
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