Clinical trial NCT03481647: 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
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Ryhov County Hospital
name: Region Jönköping County
name: Swedish Cancer Foundation
name: Kalmar County Hospital
name: Norrlands University Hospital
name: The Sjöberg Foundation
name: TUA research funding: The Sahlgrenska Academy/Region Västra Götaland
name: Malmö University
First posted: 2018-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: intensified oral care programme Control group: conventional oral care
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oral mucositis
timeFrame: First week of RT (mucositis score at one time-point)
measure: Oral mucositis
timeFrame: Second week of RT (mucositis score at one time-point)
measure: Oral mucositis
timeFrame: Third week of RT (mucositis score at one time-point)
measure: Oral mucositis
timeFrame: Fourth week of RT (mucositis score at one time-point)
measure: Oral mucositis
timeFrame: Fifth week of RT (mucositis score at one time-point)
measure: Oral mucositis
timeFrame: Sixth week of RT (mucositis score at one time-point)
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Institute of odontology
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
Study officials:
affiliation: Göteborg University
name: Annica Almståhl, Assoc.prof
role: PRINCIPAL_INVESTIGATOR
References: