Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Prophylactic dysgeusia intervention: The prophylactic dysgeusia intervention consists of one 30-minute weekly session and includes: 1. Oral hygiene assessments: questionnaire and clinical inspection to ensure a healthy oral environment, a prerequisite for the remainder of the protocol. 2. Salivary gland massages: gentle stimulation of the parotid, submandibular, and sublingual glands to increase salivation and enhance taste perception. 3. Intraoral cryotherapy: placement of an ice cube in the mouth to provide hydration, reduce mucositis, and improve oral sensitivity. 4. Taste trainings: recognition of four tastes (sweet, bitter, sour, salty) with an accompanying questionnaire.

Study summary

Taste changes, also called dysgeusia, affect 56-76% of patients with head and neck cancer treated with radiotherapy (with or without chemotherapy). These taste changes can make eating difficult, lead to weight loss, and reduce quality of life. Despite how common and impactful this problem is, there are very few standardized tools in speech-language therapy to assess or prevent it.

The aim of this study is to develop and test a preventive rehabilitation program for taste function. Eighty patients will be divided into two groups. The experimental group will receive a specific speech-language therapy intervention focused on taste for four weeks.

This intervention includes: salivary gland massage to stimulate saliva production, internal cryotherapy to keep the mouth moist and improve sensitivity, and taste training using four basic tastes at different intensity levels.

The effects of the intervention will be assessed before radiotherapy (with or without chemotherapy), at the end of treatment, and then 1, 3, 6 months, and 2 years after treatment. Assessment will include clinical tests, saliva measurements, taste detection and recognition tests, and quality-of-life questionnaires.

This clinical intervention aims to detect taste changes early and prevent them, helping to improve patients' comfort and nutrition.

Eligibility

Primary outcome measure(s)

• Quantitative taste perception — From baseline to 6 months post (chemo)radiotherapy
  The primary outcome is the change in quantitative taste perception from baseline to each follow-up evaluation. Taste perception is assessed using a 10-point Likert-scale-based gustatory evaluation, measuring perceived taste modalities (sweet, salty, bitter, and sour). The primary endpoint is defined as the presence or absence of improvement relative to baseline, assessed at Evaluation 2 (end of the intervention, corresponding to week 3 of radiotherapy), Evaluation 3 (1 month after completion of radiotherapy), Evaluation 4 (3 months after completion of radiotherapy), and Evaluation 5 (6 months after completion of radiotherapy).

Trial sites (1)

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