Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial

Abstract

Purpose A 5yr, 16 site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. Methods A home program, performed 2×/day, 6d/wk, for 12wks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0-12 times) over the 12wk intervention period. “Compliant” was defined as performing 10-12 sessions/wk. Outcomes were change in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12wks of therapy. Results Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/wk (median=10.25). Fifty four percent of patients (n=83) were considered “compliant”. After 12wks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p=0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. Conclusions The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population.

Treatment of late sequelae after radiotherapy for head and neck cancer

“…Precious few studies have examined rehabilitation interventions introduced after HNC (chemo)RT (with or without surgery) to alleviate dysphagia [104–117]. In six randomized studies, two different swallowing strategies were compared rather than to the non-interventional control group [111–117].…”

“…In six randomized studies, two different swallowing strategies were compared rather than to the non-interventional control group [111–117]. While there is single-institution evidence supporting modest effect achieved after non-preventive behavioral or exercise based swallowing interventions after (chemo)RT, they are of limited quality [118].…”

“…On the contrary, a recently published double–blinded, randomized controlled trial comparing a combination of neuromuscular electrical stimulation and swallowing exercises to exercise with sham stimulation in 170 post-RT dysphagia patients reported no benefit of electrical stimulation, and swallowing exercises alone (with sham stimulation) were found to have modest effect on diet and QOL and no improvement on radiographic measures of swallowing function [116,117]. The authors concluded that traditional swallowing exercises may not be effective in HNC patients with moderate-to severe chronic RAD, perhaps due to progressive fibrotic changes and entrapment of the swallowing apparatus induced by RT.…”

“…Despite the uncertainty of the evidence, patients with dysphagia might still be encouraged to practice swallowing exercises as the inhibitory potential of such exercises on the progression of swallowing dysfunction cannot be ruled out. An additional justification for maintenance exercise regimens draws from the possible positive effect of the simple act of practicing swallowing over and above the meal time effort which could impact the patient’s skill, ease and rate of eating [116,117]. Emerging methods such as acupuncture and manual therapies are much less integrated in routine practice, but hold promise in small clinical studies.…”

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)

“…Fifty to 60% of the HNC patients undergoing CRT may experience significant post-treatment dysphagia involving both muscle weakness and incoordination/timing issues [6][7][8]. The medical consequences (e.g., feeding-tube dependency, malnutrition, aspiration pneumonia) have a major negative impact on daily functioning and health-related quality of life (QOL) and can even be life-threatening [9][10][11][12][13][14][15]. These consequences and the high prevalence of swallowing disorders in HNC patients stress the importance of prevention, monitoring and management of this problem [16].…”