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

Göteborg University

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Procedure: Oral care programme

Study type: Interventional

Funder types: Other

Identifiers

NCT03481647

831-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Intervention

Active Comparator group

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

Treatment:

Procedure: Oral care programme

Control

No Intervention group

Description:

Professional oral care once a week according to existing routine