Head and Neck Cancer (H&N)DYSGRADNCT07431346
Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy
A study testing Prophylactic dysgeusia intervention in people with Head and Neck Cancer (H&N), run by Jules Bordet Institute at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer (H&N)
- What is being tested?
- Prophylactic dysgeusia intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HNC patients undergoing (chemo)radiotherapy
Who cannot join
- cognitive impairments
- dementia
- altered states of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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)
- Being tested
- Prophylactic dysgeusia intervention
- Keywords
- dysgeusia, head and neck cancer, radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic dysgeusia interventionBehavioural
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) with an accompanying questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 4 intervention sessions for dysgeusia and 6 evaluation sessions Receives: Behavioral: Prophylactic dysgeusia intervention |
| Control group | No intervention | 5 evaluation sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 6 months post (chemo)radiotherapy
Secondary outcomes (3)
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)
Measured: From baseline to 6 months post (chemo)radiotherapy
Sialometry
Salivary function, assessed using sialometric examination
Measured: 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.
Measured: From baseline to 6 months post (chemo)radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Feb 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431346
- Sponsor's protocol ID
- P2025/395 / CCB B4062025000170
- Acronym
- DYSGRAD
- Status last verified
- May 2026
- First submitted
- 6 Feb 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications may be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07431346
- Acronym / sponsor ID
- DYSGRAD / P2025/395 / CCB B4062025000170
- Conditions
- Head and Neck Cancer (H&N)
- Keywords
- dysgeusia, head and neck cancer, radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Prophylactic dysgeusia intervention4 intervention sessions for dysgeusia and 6 evaluation sessions |
| Control group | No intervention | –5 evaluation sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HNC patients undergoing (chemo)radiotherapy
Key exclusion criteria (3 listed)
- cognitive impairments
- dementia
- altered states of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic dysgeusia interventionThe 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. | Behavioural | Experimental group |
Primary outcome
Quantitative taste perception
Time frame: 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).
3 secondary outcomes
Dysgeusia score according to the Common Terminology Criteria for Adverse Events (CTCAE) scale
Time frame: From baseline to 6 months post (chemo)radiotherapy
Sialometry
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)
Time frame: From baseline to 6 months post (chemo)radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications may be shared upon reasonable request
Related trials for Head and Neck Cancer (H&N)
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Enrolling by invitationObservational study
Head and Neck Cancer Strategies
Head and Neck Cancer (H&N), Thyroid Cancer
RecruitingPhase 1/2
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
Solid Tumor, NSCLC
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
Recruiting
Swallowing Rehabilitation Program for Head and Neck Tumor Patients
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic dysgeusia intervention in people with Head and Neck Cancer (H&N), run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative taste perception (time frame: From baseline to 6 months post (chemo)radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.