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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer (H&N)
• Intervention / Treatment: Behavioral: Prophylactic dysgeusia intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofiana Mootassim-Billah, PhD; Phone Number: 003225417202; Email: s.mootassim-billah@hubruxelles.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HNC patients undergoing (chemo)radiotherapy

Exclusion Criteria:

• cognitive impairments
• dementia
• altered states of consciousness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 4 intervention sessions for dysgeusia and 6 evaluation sessions	Behavioral: Prophylactic dysgeusia intervention; 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) at three concentration levels, tested blind, with an accompanying questionnaire.
No Intervention: Control group; 6 evaluation sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative taste perception	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 intensity for solutions of increasing concentrations across four 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), Evaluation 5 (6 months after completion of radiotherapy), and Evaluation 6 (24 months after completion of radiotherapy).	From baseline to 2 years post (chemo)radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysgeusia score according to the Common Terminology Criteria for Adverse Events (CTCAE) scale	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)	From baseline to 2 years post (chemo)radiotherapy
Sialometry	Salivary function, assessed using sialometric examination	From baseline to 2 years post (chemo)radiotherapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)	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.	From baseline to 2 years post (chemo)radiotherapy

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Collaborators: Université Libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (Estimated): February 16, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; head and neck cancer; dysgeusia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neoplasms; Sensation Disorders; Taste Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Head and Neck Neoplasms; Dysgeusia
• Other Study ID Numbers: P2025/395 / CCB B4062025000170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the results reported in publications may be shared upon reasonable request
• IPD Sharing Time Frame: Beginning 3 months and ending 1 year after the publication of results
• IPD Sharing Access Criteria: Access to de-identified individual participant data will be considered for qualified researchers upon reasonable request. Data may be used for scientific research purposes only, consistent with the objectives of the original study. Requests will be reviewed by the principal investigator. Data will be shared through secure data transfer, with no public repository planned.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No