Health TrialsbyHealthPanel

Improved Oral Health in Head and Neck Cancer Survivors

ConditionsHead and Neck Cancer Squamous Cell CarcinomaHead and Neck Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University

About this trial

The goal of this clinical trial is to learn if an oral care programme can prevent or reduce late oral side effects in patients with head and neck cancer following treatment. The main questions it aims to answer are:

* Can additional support from hospital dental care for cancer survivors, up to three years after completion of treatment, improve patients' oral health, nutritional status, quality of life, and reduce stress and anxiety compared to standard care? * Are there differences in oral health outcomes between younger and older individuals receiving additional support from hospital dental care? * Can additional support from hospital dental care for cancer survivors, up to three years after completion of treatment, reduce the duration of sick leave and enhance patients' ability to return to work compared to standard care? * Can additional support from hospital dental care for cancer survivors, up to five years after completion of treatment, be cost-effective from a health economic perspective?

Researchers will compare oral care programme to standard care to see if the programme works to improve oral health, reduce oral symptoms and problems, enhance quality of life and lower the economic costs of healthcare

Participants will:

Participate in an oral care programme, every three months for three years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients (≥ 18 years)

diagnosed with HNC

scheduled for treatment with curative intent, including RT or CRT with or without surgery

Disqualifiers

severe alcoholism

cognitive impairment

inability to understand the Swedish language

Trial design

Design model

Single group

Treatments tested in this trial

  • Oral health support

    Other intervention

    The intervention group will receive examination and treatment by a dental hygienist every 3 months starting 6 months after completion of RT/CRT up to 3 years. During visits to the dental hygienist, they will be asked about oral hygiene habits, fluoride use, dry mouth problems, and dietary habits (including intake of easily degradable carbohydrates). Oral dryness will be assessed using the Clinical Oral Dryness Scale. The stimulated salivary secretion and buffering capacity will be assessed, and the ability to open the mouth, cariological and periodontal status and registered plaque. Based on the results of the clinical examination, the patient will get individually tailored advice and recommendations on oral hygiene, fluoride use, dry mouth relief, and support in reducing the intake of food items and drinks with high sugar content. Professional oral care will be given, and fluoride applications when indicated.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Oral health interventionOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of remaining teeth

Time frame
Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
2

Maximum interincisal opening (MIO)

Time frame
Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
3

Presence of caries

Time frame
Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
4

Loss of supporting tissue (periodontitis)

Time frame
Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years

Secondary outcomes

1

Health-related quality of life

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Developed by the European Organization for Research and Treatment of Cancer. General questionnaire for patients with cancer, 30 questions. Measures physical, role, emotional, cognitive and social functioning. One question about overall quality of life and nine questions about various symptoms, such as fatigue, pain and sleep difficulties. Likert scale with four response options. A higher score suggests a better level of functioning, while a higher score suggests more severe problems regarding symptoms.

Time frame
Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Region Västerbotten

Collaborator

Region Östergötland

Collaborator

Sjöbergstiftelsen

Collaborator

The Stig & Ragna Gorthon Foundation, Helsingborg

Collaborator

Swedish Cancer Society

Collaborator

Region of Uppsala

Collaborator

Region Skane

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: