Evaluation of an Oral Care Programme for Head and Neck Cancer Patients

Study Overview
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Brief Summary
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This study will evaluate the effect of an intensified oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region. Patients in the control group get professional oral care once a week.

Detailed Description
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This study will evaluate the effect of an oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region. The oral care programme consists of professional oral care and swabbing of the mucosal membranes with a saline/bicarbonate solution once a week. The patients are instructed to rinse with a saline/bicarbonate solution 5 times per day. They are given an oral care diary to help them keep track of their daily oral hygiene measures and rinses. Repeated oral hygiene instructions are given if needed. Patients in the control group get professional oral care once a week.

Official Title
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Evaluation of an Oral Care Programme for Patients Undergoing Treatment for Head and Neck Cancer Regarding Mucositis, Oral Health, Epigenetic Modifications, Patient-related Factors, Quality of Life and Health Economy

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: Oral care programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ≥ 16 own teeth and no removable dentures, Patients scheduled to receive full dose of RT including the major salivary glands in the radiation field Exclusion Criteria: Patients who get surgery to remove their tumor Patients with recurrent cancer Patients with severe cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group: intensified oral care programme Control group: conventional oral care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>The intervention consists of professional oral care and swabbing of the mucosal membranes with a saline and bicarbonate solution, five daily rinses with a saline and bicarbonate solution, a diary to register oral care measures and rinses | Procedure: Oral care programme<br>* Professional oral care (dental hygienist), intensified oral care measures by the patient<br>|
| No Intervention: Control<br>Professional oral care once a week according to existing routine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral mucositis | Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion <1cm2, 2=lesion 1-3 cm2, 3=lesion > 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.) | First week of RT (mucositis score at one time-point) | 
| Oral mucositis | Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion <1cm2, 2=lesion 1-3 cm2, 3=lesion > 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.) | Second week of RT (mucositis score at one time-point) | 
| Oral mucositis | Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion <1cm2, 2=lesion 1-3 cm2, 3=lesion > 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.) | Third week of RT (mucositis score at one time-point) | 
| Oral mucositis | Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion <1cm2, 2=lesion 1-3 cm2, 3=lesion > 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.) | Fourth week of RT (mucositis score at one time-point) | 
| Oral mucositis | Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion <1cm2, 2=lesion 1-3 cm2, 3=lesion > 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.) | Fifth week of RT (mucositis score at one time-point) | 
| Oral mucositis | Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion <1cm2, 2=lesion 1-3 cm2, 3=lesion > 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.) | Sixth week of RT (mucositis score at one time-point) |