Improved Oral Health in Head and Neck Cancer Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Oral health support
  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

Первичные конечные точки

• Number of remaining teeth [Срок оценки: 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]
• Maximum interincisal opening (MIO) [Срок оценки: 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]
• Presence of caries [Срок оценки: 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]
• Loss of supporting tissue (periodontitis) [Срок оценки: 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]
• Osteoradionecrosis. [Срок оценки: 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]

Вторичные конечные точки (1)

• Health-related quality of life [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Швеция · 1 центр

• Uppsala University — Uppsala

Идентификаторы

NCT: NCT07173270 · 2023-05510-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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