Head and Neck Cancer (H&N)
Conditions
Keywords
dysgeusia, head and neck cancer, radiotherapy
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.
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.
Interventions
BEHAVIORALProphylactic 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) with an accompanying questionnaire.
Sponsors
Jules Bordet Institute
Université Libre de Bruxelles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HNC patients undergoing (chemo)radiotherapy
Exclusion criteria
* cognitive impairments * dementia * altered states of consciousness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative taste perception | 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
| Measure | Time frame | Description |
|---|---|---|
| Dysgeusia score according to the Common Terminology Criteria for Adverse Events (CTCAE) scale | 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) |
| Sialometry | From baseline to 6 months post (chemo)radiotherapy | Salivary function, assessed using sialometric examination |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) | 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. |
Countries
Belgium
Outcome results
None listed