Improved Oral Health in Head and Neck Cancer Survivors (OHHNC)

Uppsala University

Status: Begins enrollment this month

Conditions: Head and Neck Cancer Squamous Cell Carcinoma; Head and Neck Cancer

Treatments: Other: Oral health support

Study type: Interventional

Funder types: Other

Identifiers

NCT07173270

2023-05510-01

Details and patient eligibility

About

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.

Full description

In Sweden, approximately 1,800 individuals are diagnosed with head and neck cancer (HNC) each year. Treatment includes radiotherapy or surgery, sometimes combined with chemotherapy. The five-year survival rate for the entire group is now approximately 70%. Despite improved five-year survival during the last two decades, side effects such as decreased salivation, difficulty swallowing, pain and radiation-induced caries are common, which negatively affect quality of life. Thus, therapeutic improvements that support oral health are highly demanded among the large group surviving head and neck cancer. The research project is a multicentre randomised controlled trial evaluating the effectiveness of an oral care programme in preventing or reducing late oral side effects in patients with HNC following treatment. Through a collaborative effort across five healthcare regions, this study aims to provide robust evidence of the efficacy of interventions designed to improve oral health outcomes and enhance the overall quality of life among head and neck cancer survivors. The intervention group will visit a dental hygienist every 3 months for oral health examination and treatment, whereas the control group will receive standard care (i.e., they will contact dental care on their own, if needed). Data collection will include patient-reported outcome measures, nutritional status, oral and dental assessments, as well as saliva and blood samples. The goal is to enhance the understanding of how oral health and quality of life can be improved in this vulnerable group, as well as how health economic costs can be reduced.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients (≥ 18 years)
• diagnosed with HNC
• scheduled for treatment with curative intent, including RT or CRT with or without surgery

Exclusion criteria

• severe alcoholism
• cognitive impairment
• inability to understand the Swedish language

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Oral health intervention

Other group

Description:

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.

Treatment:

Other: Oral health support