Radiotherapy Induced Mucositis, Head and Neck Cancer
Conditions
Keywords
Mucositis, Radiation, Honey
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTmanuka 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.
DIETARY_SUPPLEMENTplacebo 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.
Sponsors
British Columbia Cancer Agency
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study was blinded to all except necessary pharmacy staff until after the study was closed.
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment | 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 | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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. | 52 |
| Total | 106 |
Baseline characteristics
| Characteristic | Honey | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 56.8 years | 59.5 years | 58.1 years |
| Chemotherapy | 31 Participants | 35 Participants | 66 Participants |
| Diabetic | 3 Participants | 10 Participants | 13 Participants |
| ECOG > 0 | 8 Participants | 13 Participants | 21 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Radiation Therapy => 7,000 Gy | 36 Participants | 30 Participants | 66 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 44 Participants | 42 Participants | 86 Participants |
| Smoker | 9 Participants | 7 Participants | 16 Participants |
| Weight | 85.6 kg STANDARD_DEVIATION 19.3 | 79.6 kg STANDARD_DEVIATION 15.2 | 82.7 kg STANDARD_DEVIATION 17.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 52 |
| other Total, other adverse events | 8 / 54 | 6 / 52 |
| serious Total, serious adverse events | 0 / 54 | 0 / 52 |
Outcome results
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.
Time frame: Over 7 weeks of expected duration of mucositis
Population: Patients who had a minimum of 2 mucositis assessments were included in this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Honey | Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments | 11 Participants |
| Placebo | Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments | 16 Participants |
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.
Time frame: Over 7 weeks of expected duration of mucositis
Population: Patients who had at least one mucositis assessment were included in this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Honey | Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment | 14 Participants |
| Placebo | Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment | 18 Participants |