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Recruiting NCT03481647

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

No phase Interventional Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral care programme.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Oral mucositis [Time frame: First week of RT (mucositis score at one time-point)]
  • Oral mucositis [Time frame: Second week of RT (mucositis score at one time-point)]
  • Oral mucositis [Time frame: Third week of RT (mucositis score at one time-point)]
  • Oral mucositis [Time frame: Fourth week of RT (mucositis score at one time-point)]
  • Oral mucositis [Time frame: Fifth week of RT (mucositis score at one time-point)]
  • Oral mucositis [Time frame: Sixth week of RT (mucositis score at one time-point)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Sweden · 2 centers
  • Institute of odontology — Gothenburg
  • Länssjukhuset Ryhov — Jönköping

Identifiers

NCT: NCT03481647 · 831-16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗