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

Phase 3
Not Enrolling
Radiotherapy Induced Mucositis, Head and Neck Cancer

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Trial Information

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

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

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

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

- 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

- Patients allergic to honey, multiple pollens, or to celery

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Severity of mucositis according to OMAS scale

Outcome Time Frame:

Over 7 weeks of expected duration of mucositis

Safety Issue:


Principal Investigator

Philippa Hawley, B.Med

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Ethics Review Committee

Study ID:




Start Date:

July 2008

Completion Date:

October 2011

Related Keywords:

  • Radiotherapy Induced Mucositis
  • Head and Neck Cancer
  • Mucositis
  • Radiation
  • Honey
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis