Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ryhov County Hospital | OTHER |
| Region Jönköping County | OTHER_GOV |
| Swedish Cancer Foundation | OTHER |
| Kalmar County Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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 |
|
| Control | No Intervention | Professional oral care once a week according to existing routine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral care programme | Procedure | Professional oral care (dental hygienist), intensified oral care measures by the patient |
|
| 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.) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annica Almståhl, Assoc.prof | Contact | +46317863208 | annica.almstahl@odontologi.gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Annica Almståhl, Assoc.prof | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of odontology | Active, not recruiting | Gothenburg | 41390 | Sweden | ||
| Länssjukhuset Ryhov |
We are not planning to make IPD available to researchers not involved in the project
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| OTHER |
| Norrlands University Hospital | OTHER |
| The Sjöberg Foundation | UNKNOWN |
| TUA research funding: The Sahlgrenska Academy/Region Västra Götaland | UNKNOWN |
| Malmö University | OTHER |
Intervention group: intensified oral care programme Control group: conventional oral care
Not provided
Not provided
The participants will not be aware of the care/treatment given to the other group
| 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) |
| Recruiting |
| Jönköping |
| Sweden |
|