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

Swallowing requires a complex interaction between various muscles in the
tongue, floor of mouth, pharynx, and larynx. This complex physiologic course of
muscle events and interactions is at risk in patients treated for head and neck
cancer (HNC). Swallowing impairment/dysphagia is not uncommon in these
patients. It can be caused by the tumor extension itself, but maybe even more
so, because of surgical resection and trauma as well as tissue reactions
resulting from (organ preserving) chemoradiotherapy (CRT). Tongue strength,
which also plays a role in the swallowing physiology, is reduced in patients
treated with primary CRT. When, because of pain and dysphagia during treatment,
the swallowing muscles are no longer actively used, the swallowing muscles
might eventually atrophy, which further limits swallowing function.
Implementation of preventive swallowing exercises has been demonstrated to
prevent this so-called *non-use atrophy* in patients with advanced HNC
undergoing CRT, to improve post-treatment swallowing function and quality of
life. Based on the positive experiences with the TheraBite as a preventive
exercise tool with good compliance, a new Swallow Exercise Aid (SEA) was
developed, with the aim to overcome persistent/therapy-resistant swallowing
problems. The effectiveness and feasibility of a SEA-based exercise protocol
recently has been demonstrated in a prospective study in senior healthy
subjects. Compliance appeared to be high (86%) and there was a significant
increase of swallowing muscle strength and volume, anterior tongue strength,
and some increase in mouth opening after six weeks of extensive swallowing
training. Following these positive results, the effectiveness and feasibility
of this SEA-based exercise protocol will now be studied in HNC patients with
chronic/therapy-resistant dysphagia, who all have feeding tube dependency
and/or high risk for developing aspiration pneumonia, despite routine previous
swallowing exercise programs.

Primary objective: effectiveness of the SEA exercises in HNC patients with
chronic dysphagia, following an exercise protocol of 6 weeks.

Secondary objective: feasibility/compliance of the SEA exercises in HNC
patients with chronic dysphagia, during the 6 weeks exercise regimen.

Uncontrolled, prospective clinical cohort study.

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) exercise
3. Effortful swallow exercise

Exercise and assessment protocol:
The (isokinetic and isometric) strengthening exercises are performed 3 times
per day (15-20 minutes) during 6 weeks.
All patients will be asked to record their performances by using tally sheets
in a special exercise log.

Also see the exercise protocol for more detailed instructions.

The general benefit of using the SEA is the possibility to improve swallowing
function and to overcome dysphagia (i.e. tube feeding dependency). Foreseeable
disadvantages may be pain, itchiness, or irritated skin (rash) at the chest due
to compression of the chest bar onto the sternum, or at the chin due to
compression of the chin bar. Also complaints of discomfort or pain in/around
the jaw joint (muscle ache) may occur during the exercise period with the use
of the SEA. However, based on the experiences with the SEA in senior healthy
subjects, the surmountable burden which occurred was transient. Nevertheless,
in case of (severe) muscle aches, the patient will be instructed to reduce the
force required to press the chin bar onto the chest bar.