Objectives <p>Radiotherapy for head and neck cancer (HNC) frequently results in irreversible salivary gland damage and persistent xerostomia. This study aimed to assess the efficacy of a topical mucoadhesive disc containing xylitol in comparison to water with respect to (i) subjective symptom burden of nocturnal dry mouth and (ii) objective salivary flow parameters in post-radiotherapy HNC patients.</p> Materials and methods <p>In a randomized, single-blind, crossover-controlled clinical trial, 33 patients with radiotherapy-induced xerostomia received either adhesive discs (XyliMelts) or water across two treatment phases, separated by a washout period of 7 days. Subjective outcomes were assessed using a 100&#xa0;mm visual analogue scale (VAS) and the Shahdad symptom relief questionnaire. Objective measures included unstimulated and stimulated salivary flow rates. Within-group pre-post comparisons were analyzed using paired t-tests or Wilcoxon signed-rank tests; between-group differences were assessed using independent t-tests or Mann-Whitney U tests (<i>p</i> &lt; 0.05).</p> Results <p>Adhesive discs use was associated with significantly greater subjective symptom relief (76% vs. 24%; <i>p</i> &lt; 0.001), improved sleep continuity (67% vs. 9%; <i>p</i> &lt; 0.001), and higher willingness to continue product use (70% vs. 30%; <i>p</i> = 0.044). Perceived oral moisture, comfort, and flavor ratings were also higher with adhesive discs. No changes were observed in salivary flow parameters. Tolerability was high, with minimal adverse events reported.</p> Conclusions <p>Topical, symptom-oriented interventions may provide meaningful relief for patients suffering from post-radiotherapy xerostomia, especially when regenerative treatment options are limited. Further clinical trials are warranted to confirm these findings in larger populations and to evaluate long-term efficacy and safety.</p> Clinical relevance <p>Mucoadhesive xylitol discs appear to be well tolerated and are perceived as beneficial by patients experiencing xerostomia following HNC therapy.</p>

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Efficacy of adhesive discs for nocturnal xerostomia after head and neck radiotherapy: a randomized crossover trial

  • Christoph Matthias Schoppmeier,
  • Stefan Zimmer,
  • Alicia Maria Meyer-Hofmann,
  • Elmar Ludwig,
  • Anna Greta Barbe

摘要

Objectives

Radiotherapy for head and neck cancer (HNC) frequently results in irreversible salivary gland damage and persistent xerostomia. This study aimed to assess the efficacy of a topical mucoadhesive disc containing xylitol in comparison to water with respect to (i) subjective symptom burden of nocturnal dry mouth and (ii) objective salivary flow parameters in post-radiotherapy HNC patients.

Materials and methods

In a randomized, single-blind, crossover-controlled clinical trial, 33 patients with radiotherapy-induced xerostomia received either adhesive discs (XyliMelts) or water across two treatment phases, separated by a washout period of 7 days. Subjective outcomes were assessed using a 100 mm visual analogue scale (VAS) and the Shahdad symptom relief questionnaire. Objective measures included unstimulated and stimulated salivary flow rates. Within-group pre-post comparisons were analyzed using paired t-tests or Wilcoxon signed-rank tests; between-group differences were assessed using independent t-tests or Mann-Whitney U tests (p < 0.05).

Results

Adhesive discs use was associated with significantly greater subjective symptom relief (76% vs. 24%; p < 0.001), improved sleep continuity (67% vs. 9%; p < 0.001), and higher willingness to continue product use (70% vs. 30%; p = 0.044). Perceived oral moisture, comfort, and flavor ratings were also higher with adhesive discs. No changes were observed in salivary flow parameters. Tolerability was high, with minimal adverse events reported.

Conclusions

Topical, symptom-oriented interventions may provide meaningful relief for patients suffering from post-radiotherapy xerostomia, especially when regenerative treatment options are limited. Further clinical trials are warranted to confirm these findings in larger populations and to evaluate long-term efficacy and safety.

Clinical relevance

Mucoadhesive xylitol discs appear to be well tolerated and are perceived as beneficial by patients experiencing xerostomia following HNC therapy.