Radiotherapy Induced MucositisPhase 3NCT00615420
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
A Phase 3 study testing manuka honey in people with Radiotherapy Induced Mucositis and Head and Neck Cancer, run by British Columbia Cancer Agency at 2 sites in Canada.
Trial 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 therapy for cancer treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiotherapy Induced Mucositis, Head and Neck Cancer
- What is being tested?
- manuka honey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2008to Oct 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
BC Cancer Agency
Surrey, British Columbia
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
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.
Read the 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.
- Being tested
- manuka honey, placebo gel
- Keywords
- Mucositis, Radiation, Honey
- Medical subject headings
- Head and Neck Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manuka honeyDietary 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 gelDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Manuka Honey | Experimental | Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed Receives: Dietary Supplement: manuka honey |
| Placebo | Placebo comparator | Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed Receives: Dietary Supplement: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment
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.
Measured: 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
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.
Measured: Over 7 weeks of expected duration of mucositis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radiotherapy Induced MucositisStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippa Hawley, B.Med, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615420
- Sponsor's protocol ID
- H07-02297
- Other IDs
- H07-02297
- Status last verified
- May 2012
- First submitted
- 4 Feb 2008
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
- ClinicalTrials.gov ID
- NCT00615420
- Acronym / sponsor ID
- H07-02297
- Keywords
- Mucositis, Radiation, Honey
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Posted 5 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manuka Honey | Experimental | Dietary Supplement: manuka honeyIrradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed |
| Placebo | Placebo comparator | Dietary Supplement: placebo gelSugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manuka honeyIrradiated 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. | Dietary supplement | Manuka Honey |
| placebo gelSugar-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. | Dietary supplement | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Radiotherapy Induced Mucositis
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Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
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Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
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Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
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Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Radiation-induced Oral Mucositis, Head and Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippa Hawley, B.Med principal investigator
British Columbia Cancer Agency
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing manuka honey in people with Radiotherapy Induced Mucositis and Head and Neck Cancer, run by British Columbia Cancer Agency at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.