Evaluation of an Oral Care Programme for Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481647
• Other study ID #: 831-16
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: Göteborg University
• Contact: Annica Almståhl, Assoc.prof
• Phone: +46317863208
• Email: annica.almstahl[@]odontologi.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• Oral care programme
Professional oral care (dental hygienist), intensified oral care measures by the patient

Locations

Country	Name	City	State
Sweden	Institute of odontology	Gothenburg
Sweden	Länssjukhuset Ryhov	Jönköping

Sponsors (6)

Lead Sponsor	Collaborator
Göteborg University	Kalmar County Hospital, Norrlands University Hospital, Region Jönköping County, Ryhov County Hospital, Swedish Cancer Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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.)	Fourth week of RT (mucositis score at one time-point)
Primary	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)
Primary	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)