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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Göteborg University
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Oral mucositis
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled to receive full dose of curative RT including major salivary glands in the radiation field
Exclusion Criteria
- •Patients with recurrent cancer
- •Patients with severe cognitive impairment.
Outcomes
Primary Outcomes
Oral mucositis
Time Frame: Sixth week of RT (mucositis score at one time-point)
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.)