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

NCT ID: NCT03481647

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group: intensified oral care programme Control group: conventional oral care
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The participants will not be aware of the care/treatment given to the other group

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

Oral care programme

Intervention Type PROCEDURE

Professional oral care (dental hygienist), intensified oral care measures by the patient

Control

Professional oral care once a week according to existing routine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral care programme

Professional oral care (dental hygienist), intensified oral care measures by the patient

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ryhov County Hospital

OTHER

Sponsor Role collaborator

Region Jönköping County

OTHER_GOV

Sponsor Role collaborator

Swedish Cancer Foundation

OTHER

Sponsor Role collaborator

Kalmar County Hospital

OTHER

Sponsor Role collaborator

Norrlands University Hospital

OTHER

Sponsor Role collaborator

The Sjöberg Foundation

UNKNOWN

Sponsor Role collaborator

TUA research funding: The Sahlgrenska Academy/Region Västra Götaland

UNKNOWN

Sponsor Role collaborator

Malmö University

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annica Almståhl, Assoc.prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Institute of odontology

Gothenburg, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Länssjukhuset Ryhov

Jönköping, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Annica Almståhl, Assoc.prof

Role: CONTACT

+46317863208

Facility Contacts

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Charlott Karlsson, RDH

Role: primary

+4636326000

Other Identifiers

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831-16

Identifier Type: -

Identifier Source: org_study_id

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