A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Radiotherapy Induced Mucositis Head and Neck Cancer |
Dietary Supplement: manuka honey Dietary Supplement: placebo gel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer |
- Severity of mucositis according to OMAS scale [ Time Frame: Over 7 weeks of expected duration of mucositis ] [ Designated as safety issue: No ]
- Percentage weight loss [ Time Frame: From day one of radiation to last day of week following completion of radiation ] [ Designated as safety issue: No ]
| Enrollment: | 106 |
| Study Start Date: | July 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
|
Dietary Supplement: manuka honey
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: 2
Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed
|
Dietary Supplement: placebo gel
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, British Columbia | |
| BC Cancer Agency | |
| Surrey, British Columbia, Canada | |
| BC Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Principal Investigator: | Philippa Hawley, B.Med | British Columbia Cancer Agency |
More Information
No publications provided
| Responsible Party: | British Columbia Cancer Agency |
| ClinicalTrials.gov Identifier: | NCT00615420 History of Changes |
| Other Study ID Numbers: | H07-02297, H07-02297 |
| Study First Received: | February 4, 2008 |
| Last Updated: | May 22, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by British Columbia Cancer Agency:
|
Mucositis Radiation Honey |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Stomatitis Mucositis Neoplasms by Site Neoplasms |
Mouth Diseases Stomatognathic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013