Evaluation of an Oral Care Programme for Head and Neck Cancer Patients
ConditionHead and Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGöteborg University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled to receive full dose of curative RT including major salivary glands in the radiation field
Disqualifiers
Patients with recurrent cancer
Patients with severe cognitive impairment.
Trial design
Design model
Parallel
Treatments tested in this trial
Oral care programme
Procedure/SurgeryProfessional oral care (dental hygienist), intensified oral care measures by the patient
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.)
Time frame
First week of RT (mucositis score at one time-point)2
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.)
Time frame
Second week of RT (mucositis score at one time-point)3
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.)
Time frame
Third week of RT (mucositis score at one time-point)4
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.)
Time frame
Fourth week of RT (mucositis score at one time-point)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Göteborg University
Lead sponsor
Ryhov County Hospital
Collaborator
Region Jönköping County
Collaborator
Swedish Cancer Foundation
Collaborator
Kalmar County Hospital
Collaborator
Norrlands University Hospital
Collaborator
The Sjöberg Foundation
Collaborator
TUA research funding: The Sahlgrenska Academy/Region Västra Götaland
Collaborator
Malmö University
Collaborator
Source ClinicalTrials.gov