Head and Neck Cancer
Conditions
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.
Interventions
PROCEDUREOral care programme
Professional oral care (dental hygienist), intensified oral care measures by the patient
Sponsors
Ryhov County Hospital
Region Jönköping County
Swedish Cancer Foundation
Kalmar County Hospital
Norrlands University Hospital
The Sjöberg Foundation
TUA research funding: The Sahlgrenska Academy/Region Västra Götaland
Malmö University
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The participants will not be aware of the care/treatment given to the other group
Intervention model description
Intervention group: intensified oral care programme Control group: conventional oral care
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral mucositis | First 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.) |
Countries
Sweden
Contacts
Primary ContactAnnica Almståhl, Assoc.prof
Outcome results
None listed