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O estudo clínico NCT07173270 (OHHNC) para Head and Neck Cancer Squamous Cell Carcinoma, Câncer de cabeça e pescoço está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Improved Oral Health in Head and Neck Cancer Survivors (OHHNC) 300

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07173270 (OHHNC) é um estudo intervencionista para Head and Neck Cancer Squamous Cell Carcinoma, Câncer de cabeça e pescoço. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 24 de setembro de 2025, com o objetivo de incluir 300 participantes. Coordenado por a Universidade de Uppsala e deve ser concluído em 23 de setembro de 2045. Essas informações foram atualizadas no ClinicalTrials.gov em 15 de setembro de 2025.
Resumo

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 st...
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Descrição detalhada
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 carie...Mostrar mais
Título oficial

Improved Oral Health in Head and Neck Cancer Survivors

Condições médicas
Head and Neck Cancer Squamous Cell CarcinomaCâncer de cabeça e pescoço
Outros IDs do estudo
  • OHHNC
  • 2023-05510-01
Número NCT
NCT07173270
Data de início (real)
2025-09-24
Última atualização postada
2025-09-15
Data de conclusão (estimada)
2045-09-23
Inscrição (estimada)
300
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
Head and neck cancer
Nutrition
Oral health
cancer survivors
Quality of Life
healthcare costs
Propósito principal
Prevenção
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
OutroOral health 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.
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....Mostrar mais
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Number of remaining teeth
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)
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
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)
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.
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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.
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.
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • patients (≥ 18 years)
  • diagnosed with HNC
  • scheduled for treatment with curative intent, including RT or CRT with or without surgery

  • severe alcoholism
  • cognitive impairment
  • inability to understand the Swedish language
Uppsala University logoUniversidade de Uppsala
  • 🏛️Region Västerbo...
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Contato central do estudo
Contato: Ylva Tiblom Ehrsson, Assoc professor, RN, +46707747712, [email protected]
1 Locais do estudo em 1 países
Uppsala University, Uppsala, 751 85, Sweden