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Clinical Trials/ISRCTN12377415
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.

Registry
who.int
Start Date
March 4, 2022
End Date
July 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London

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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