An interventional study of Prophylactic dysgeusia intervention in Head and Neck Cancer (H&N), sponsored by Jules Bordet Institute. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Jules Bordet Institute · Not applicable, Interventional, and Prevention
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 80 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Jules Bordet Institute is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
4 intervention sessions for dysgeusia and 6 evaluation sessions
Behavioral: Prophylactic dysgeusia intervention
5 evaluation sessions
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.
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 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).
Time frame: From baseline to 6 months post (chemo)radiotherapy
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)
Time frame: From baseline to 6 months post (chemo)radiotherapy
Sialometry
Salivary function, assessed using sialometric examination
Time frame: From baseline to 6 months 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.
Time frame: From baseline to 6 months post (chemo)radiotherapy
Plan to share: Yes — De-identified individual participant data that underlie the results reported in publications may be shared upon reasonable request
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Apr 2027, 14 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 14 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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