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

NCT07431346 | Not Yet Recruiting

• 1 other identifier: P2025/395 / CCB B4062025000170
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Head and Neck Cancer (H&N)

Keywords

dysgeusia; head and neck cancer; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  From baseline to 2 years post (chemo)radiotherapy

• Sialometry

  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)

  From baseline to 2 years post (chemo)radiotherapy

Study Arms (2)

Experimental group

EXPERIMENTAL

4 intervention sessions for dysgeusia and 6 evaluation sessions

Behavioral: Prophylactic dysgeusia intervention

Control group

NO INTERVENTION

6 evaluation sessions

Interventions

Prophylactic dysgeusia intervention BEHAVIORAL

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) at three concentration levels, tested blind, with an accompanying questionnaire.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HNC patients undergoing (chemo)radiotherapy

You may not qualify if:

• cognitive impairments
• dementia
• altered states of consciousness

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Université Libre de Bruxelles: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms; Dysgeusia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sofiana Mootassim-Billah, PhD

CONTACT

003225417202; s.mootassim-billah@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 24, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 1 year after the publication of results
• 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.