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

Phase 2

Recruiting

Conditions: Dysphagia
swallowing impairment
10027656

Registration Number: NL-OMON42230

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Effectiveness endpoints:<br /><br>- Swallowing muscle strength (in Newton)<br /><br>o Maximum chin tuck strength<br /><br>o Maximum jaw-opening strength<br /><br>- Tongue strength and endurance (in kilopascal)<br /><br>- Videofluoroscopy swallowing parameters<br /><br>o Swallowing transport times (in seconds)<br /><br>o Anterior/superior hyoid bone displacement (in millimetres)<br /><br>o Presence of penetration/aspiration<br /><br>o Presence of contrast residue<br /><br><br /><br>Feasibility/compliance endpoints:<br /><br>- Feasibility of the SEA exercises (study-specific questionnaire)<br /><br>- Compliance of the SEA exercises (study-specific questionnaire)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional endpoints:<br /><br>- Maximum mouth opening (in millimetres)<br /><br>- Tube feeding dependency<br /><br>- Oral intake / nutritional status (FOIS score)<br /><br>- Weight and BMI<br /><br>- Subjective perspective on swallowing function (SWAL-QOL questionnaire)</p><br>