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| ID | Type | Description | Link |
|---|---|---|---|
| H07-02297 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manuka Honey | Experimental | Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed |
|
| Placebo | Placebo Comparator | Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Over 7 weeks of expected duration of mucositis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa Hawley, B.Med | British Columbia Cancer Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency | Surrey | British Columbia | Canada | |||
| BC Cancer Agency |
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| ID | Title | Description |
|---|---|---|
| FG000 | Honey | Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed 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. |
| FG001 | Placebo | Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Honey | Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not all patients have baseline information available |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients who had at least one mucositis assessment were included in this analysis | Posted | Count of Participants | Participants | Over 7 weeks of expected duration of mucositis |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Honey | Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philippa Hawley | BC Cancer | (604) 877-6000 | 67-2752 | phawley@bccancer.bc.ca |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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The study was blinded to all except necessary pharmacy staff until after the study was closed.
| 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. |
|
| Vancouver |
| British Columbia |
| V5Z 4E6 |
| Canada |
| Placebo |
Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Not all patients have baseline information available | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Not all patients have baseline information available | Mean | Standard Deviation | kg |
|
| Diabetic | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| ECOG > 0 | Count of Participants | Participants |
|
| Chemotherapy | Count of Participants | Participants |
|
| Radiation Therapy => 7,000 Gy | Gy = Gray; the international system unit of radiation dose | Count of Participants | Participants |
|
| OG001 | Placebo | Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed 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. |
|
|
| Primary | 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. | Patients who had a minimum of 2 mucositis assessments were included in this analysis | Posted | Count of Participants | Participants | Over 7 weeks of expected duration of mucositis |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 8 |
| 54 |
| EG001 | Placebo | Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed 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. | 0 | 52 | 0 | 52 | 6 | 52 |
| Bad Taste | Product Issues |
|
| Burning Sensation in Mouth | Product Issues |
|
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| D004066 |
| Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |