Evaluation of an Oral Care Programme for Head and Neck Cancer Patients
Primary Purpose
Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Oral care programme
Sponsored by
About this trial
This is an interventional prevention trial for Head and Neck Cancer
Eligibility Criteria
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.
Sites / Locations
- Institute of odontology
- Länssjukhuset RyhovRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
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
Professional oral care once a week according to existing routine
Outcomes
Primary Outcome Measures
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.)
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.)
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.)
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.)
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.)
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.)
Secondary Outcome Measures
Full Information
NCT ID
NCT03481647
First Posted
January 16, 2018
Last Updated
August 25, 2021
Sponsor
Göteborg University
Collaborators
Ryhov County Hospital, Region Jönköping County, Swedish Cancer Foundation, Kalmar County Hospital, Norrlands University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03481647
Brief Title
Evaluation of an Oral Care Programme for Head and Neck Cancer Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Ryhov County Hospital, Region Jönköping County, Swedish Cancer Foundation, Kalmar County Hospital, Norrlands University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention group: intensified oral care programme Control group: conventional oral care
Masking
Participant
Masking Description
The participants will not be aware of the care/treatment given to the other group
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Professional oral care once a week according to existing routine
Intervention Type
Procedure
Intervention Name(s)
Oral care programme
Intervention Description
Professional oral care (dental hygienist), intensified oral care measures by the patient
Primary Outcome Measure Information:
Title
Oral mucositis
Description
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)
Title
Oral mucositis
Description
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)
Title
Oral mucositis
Description
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)
Title
Oral mucositis
Description
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)
Title
Oral mucositis
Description
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
Fifth week of RT (mucositis score at one time-point)
Title
Oral mucositis
Description
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
Sixth week of RT (mucositis score at one time-point)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annica Almståhl, Assoc.prof
Phone
+46317863208
Email
annica.almstahl@odontologi.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annica Almståhl, Assoc.prof
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of odontology
City
Gothenburg
ZIP/Postal Code
41390
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Länssjukhuset Ryhov
City
Jönköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlott Karlsson, RDH
Phone
+4636326000
Email
charlott.karlsson@rjl.se
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to make IPD available to researchers not involved in the project
Learn more about this trial
Evaluation of an Oral Care Programme for Head and Neck Cancer Patients
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