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

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.

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Key information

Conditions

Radiotherapy Induced Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Mucositis Neoplasms Neoplasms by Site Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BC Cancer Agency, Surrey, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manuka honey

Dietary Supplement

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 gel

Dietary Supplement

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.

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Feb 14, 2008
Registry last updated: Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed