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NCT Number: NCT07431346

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

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.

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Key information

Conditions

Head and Neck Cancer (H&N) Dysgeusia Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Taste Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jules Bordet Institute

Brussels, Belgium

About this study

Dysgeusia affects 56-76% of head and neck cancer (HNC) patients undergoing (chemo)radiotherapy, impacting nutrition and quality of life. Standardized assessment and rehabilitation are limited. This study aims to develop and validate a 4-week prophylactic speech-language pathology protocol-including salivary gland massage, internal cryotherapy, and taste training-to preserve taste function. Eighty HNC patients undergoing (chemo)radiotherapy will be randomized to control (no intervention) or experimental (undergoing the 4-week intervention) groups. Outcomes of both groups will be assessed via clinical scales, sialometry, taste thresholds, and quality-of-life questionnaires at baseline, week 4, and 1, 3-, 6-months and 2 years post (chemo)radiotherapy. The proposed protocol is expected to be feasible in clinical settings, with potential for early detection and prophylactic preservation of taste function in HNC patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HNC patients undergoing (chemo)radiotherapy

Exclusion criteria

  • cognitive impairments
  • dementia
  • altered states of consciousness

Treatment and study plan

Prophylactic dysgeusia intervention

Behavioral

The prophylactic dysgeusia intervention consists of one 30-minute weekly session and includes:

  • Oral hygiene assessments: questionnaire and clinical inspection to ensure a healthy oral environment, a prerequisite for the remainder of the protocol.
  • Salivary gland massages: gentle stimulation of the parotid, submandibular, and sublingual glands to increase salivation and enhance taste perception.
  • Intraoral cryotherapy: placement of an ice cube in the mouth to provide hydration, reduce mucositis, and improve oral sensitivity.
  • Taste trainings: recognition of four tastes (sweet, bitter, sour, salty) with an accompanying questionnaire.

Primary outcomes

  1. Quantitative taste perception

    Time frame: 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).

Secondary outcomes

  1. Dysgeusia score according to the Common Terminology Criteria for Adverse Events (CTCAE) scale

    Time frame: From baseline to 6 months post (chemo)radiotherapy

    Clinical toxicity grade of dysgeusia, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale, graded from 1 (least severe) to 5 (most severe)

  2. Sialometry

    Time frame: From baseline to 6 months post (chemo)radiotherapy

    Salivary function, assessed using sialometric examination

  3. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)

    Time frame: From baseline to 6 months post (chemo)radiotherapy

    Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43), administered in accordance with European Organisation for Research and Treatment of Cancer (EORTC) scoring guidelines, with scores ranging from 0 to 100. Scores range from 0 to 100, with higher scores indicating greater symptom burden or functional impairment, depending on the subscale.

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Collaborators

  • Université Libre de Bruxelles

Registry information

Official study title

Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy: a Randomized Control Trial

Acronym: DYSGRAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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