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 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42230

Enrollment

Registered

2015-01-09

Start date

2015-04-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia swallowing impairment

Interventions

Intervention: There are the three strengthening exercises to be performed with the Swallow Exercise Aid: 1. Chin tuck against resistance (CTAR) exercise 2. Jaw opening against resistance (JOAR) exerc

Eligibility

Age

18 Years to 99 Years

Inclusion 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 (= 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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Additional endpoints: - Maximum mouth opening (in millimetres) - Tube feeding dependency - Oral intake / nutritional status (FOIS score) - Weight and BMI - Subjective perspective on swallowing function (SWAL-QOL questionnaire)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)