NL-OMON42230
Recruiting
Phase 2
Phase-2 clinical trial on the treatment of chronic dysphagia in head and neck cancer patients with dedicated strengthening exercises using the Swallow Exercise Aid - Strengthening exercises in head and neck cancer patients with dysphagia
Antoni van Leeuwenhoek Ziekenhuis0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dysphagia
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients who have been treated successfully with concurrent chemoradiotherapy or radiotherapy alone for head and neck cancer, for at least 1 year ago;
- •\- Patients who are diagnosed with chronic (therapy\-resistant) dysphagia for at least 1 year:
- •o Presence of penetration and/or aspiration on recent (\< 3 months) videofluoroscop; and/or
- •o Seriously limited intake of a normal diet;and/or
- •o Presence of a (nasogastric or percutaneous) feeding tube; and/or
- •o Occurrence of recurrent (\>\= 1 during the last year) aspiration pneumonia; and
- •o Unresponsive/refractory to regular logopaedic swallowing therapy;
- •\- Patients who are able and willing to perform the exercises with the Swallow Exercise Aid for 6 weeks.
Exclusion Criteria
- •\- Patients treated surgically for head and neck cancer (except for any kind of neck dissection);
- •\- Patients with recurrent or residual head and neck cancer disease;
- •\- Patients unable to comprehend the function of the Swallow Exercise Aid;
- •\- Patients physically unfit (e.g. due to the occurrence of a tracheotomy) or unwilling to use the Swallow Exercise Aid daily;
- •\- Patients living abroad.
Outcomes
Primary Outcomes
Not specified
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