ISRCTN12377415
Active, not recruiting
未知
Prehabilitation of swallowing difficulties in people with head and neck cancer: A pilot cluster randomised trial and process evaluation
niversity College London0 sites72 target enrollmentMarch 4, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Head and neck cancer
- Sponsor
- niversity College London
- Enrollment
- 72
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults over the age of 18 years.
- •2\. Both males and females.
- •3\. Clinical and Radiological diagnosis of new stage III/IV tumour of the head and neck (oral cavity, oropharynx, nasopharynx, hypopharynx, mandible, maxilla, unknown primary with planned bilateral neck radiation)
- •4\. Discussed at the multidisciplinary team (MDT) meeting and planned for treatment with curative intent via surgery, radiotherapy, chemoradiotherapy or combinations thereof.
- •5\. Able to provide informed consent.
- •6\. Patients who do not have English as their first language but for whom appropriate translation services as per local hospital practice is in place.
Exclusion Criteria
- •1\. Patients with a previous diagnosis of head and neck cancer.
- •2\. Patients who have not consented prior to cancer treatment, or those receiving palliation.
- •3\. Patients who are to be treated solely by non\-standard treatment such as photodynamic therapy, brachytherapy or chemotherapy alone.
- •4\. Patients who are planned for a total laryngectomy or long\-term tracheostomy.
- •5\. Patients who are vulnerable and/or have significant co\-morbidities as determined by the clinical team and/or with a score of 4 on the WHO performance status scale.
- •6\. Patients who have long\-term medical history of neurological conditions resulting in known pre\-existing dysphagia.
- •7\. Patients with brain tumours and other primary sites not within head and neck.
- •8\. Patients who are unable to provide informed consent
Outcomes
Primary Outcomes
Not specified
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