NCT07431346

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Head and Neck Cancer (H&N)

Interventions

Type	Name	Description
BEHAVIORAL	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) at three concentration levels, tested blind, with an accompanying questionnaire.

Timeline

• Start date: 2026-02-16
• Primary completion: 2027-04-30
• Completion: 2027-09-30
• First posted: 2026-02-24
• Last updated: 2026-02-24