Metastatic Triple Negative Breast CancerTASTY-steeringNCT07258563
The TASTY-steering Study
A study testing Taste steering in people with Metastatic Triple Negative Breast Cancer and Metastatic Testicular Cancer, run by University Medical Center Groningen at 11 sites in Netherlands.
Trial summary
This is a multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands. A parallel cluster design per hospital was selected to prevent contact between participants in the same hospital who are randomised into different… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Triple Negative Breast Cancer, Metastatic Testicular Cancer, Stage II-IV Diffuse Large B Cell Lymphoma
- What is being tested?
- Taste steering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 11 sitesNetherlands
- Study dates
- 6 Jun 2025to Jul 2028
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤70 years
- Indication to start chemotherapy for:
- Metastatic triple negative breast cancer
- Metastatic testicular cancer
- Stage II-IV diffuse large B cell lymphoma
- Chemotherapy scheduled to start in the next 6 weeks
Show all 12Show fewer
- Consuming solid foods and drinks is possible
- ≤50% of recommended daily intake in kcal consists of oral nutritional supplements
- Oral mucositis grade ≤2 (Common Terminology Criteria for Adverse Events, version 5.0)
- Ability to comply with all protocol-required actions
- Written informed consent
- For the intervention phase only: subjective change in taste since start of chemotherapy
Who cannot join
- Pregnancy
- Currently experiencing taste or smell problems
- Previous or current radiotherapy of head and neck region
- Enteral feeding through tube or parenteral feeding
- Participation in another clinical trial aimed at preventing or treating taste and/or smell alterations
- Chronic (>1 month) high dose corticosteroids (>10 mg prednisone/day or equivalent).
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
K. Silverio Alonso-Duin
- Not yet recruiting
Rijnstate Ziekenhuis
Arnhem
M. D.J.L. van der Vorst
- Not yet recruiting
Van Weel-Bethesda Ziekenhuis
Dirksland
H. Noordzij-Nooteboom
- Recruiting
Ziekenhuisvoorzieningen Gelderse Vallei
Ede
G. A. Velders
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
J. J. de Haan, MD, PhD, +31 50 361 2821, j.j.de.haan@umcg.nl
M. D. Douma, +31 50 361 4603, m.d.douma@umcg.nl
- Recruiting
Martini Ziekenhuis
Groningen
A. W.G. van der Velden
- Not yet recruiting
Radboud University Medical Center
Nijmegen
S. Kaal
- Recruiting
Ikazia Ziekenhuis
Rotterdam
F. de Boer
- Recruiting
Ommelander Ziekenhuis Groningen
Scheemda
T. Osinga-Fickweiler
- Not yet recruiting
Maxima Medisch Centrum
Veldhoven
R. van Lieshout
- Not yet recruiting
Isala Klinieken
Zwolle
J. W.B. de Groot
About this study
Official title: Taste Steering in Patients With Cancer Who Are Treated With Chemotherapy: a Multicentre Randomized Intervention Trial
This is a multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands. A parallel cluster design per hospital was selected to prevent contact between participants in the same hospital who are randomised into different study arms. Such contact may result in bias as it may allow for patients in the control arm to be informed about elements of taste steering.
To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks.
Some hospitals have implemented elements of taste steering. However, these elements are focused on patients who are admitted to the hospital, and therefore only interfere to a limited extent with the present study that is directed at patients managing their taste alterations at home. Experience with the Smaakpupil tool indicates that the algorithm reaches saturation after 3-4 weeks. Therefore, an intervention period of 6 weeks has been selected.
- Conditions
- Metastatic Triple Negative Breast Cancer, Metastatic Testicular Cancer, Stage II-IV Diffuse Large B Cell Lymphoma
- Being tested
- Taste steering
- Keywords
- Taste Alterations
- Medical subject headings
- Triple Negative Breast Neoplasms, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste steeringBehavioural
To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Taste steering | Experimental | To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. Receives: Behavioral: Taste steering |
| No intervention | No intervention | standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food enjoyment in appetite, hunger and sensory perception
Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) after 6 weeks of taste steering compared with standard care. The AHSP uses a 5-point Likert scale (1-5), with higher scores indicating greater appetite, hunger, or sensory changes.
Measured: 6 weeks
Secondary outcomes (8)
Food enjoyment and liking
Food enjoyment and food liking: questions on food enjoyment and food liking on 9-point hedonic scale. Higher scores on the Food enjoyment and food liking indicate more food enjoyment and food liking.
Measured: 6 weeks
Health-related quality of life
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30 questionnaire) assesses quality of life. It is measured using 1-4 and 1-7 scales. Higher scores indicate better functioning and global quality of life, and worse symptoms on symptom domains.
Measured: 6 weeks
Taste and smell alterations
The Chemotherapy-induced Taste Alteration Scale (ciTAS-NL) assesses taste and smell alterations across intensity, discomfort, and phantogeusia/parageusia domains. It is measured using a 5-point Likert scale. Higher scores indicate more severe alterations.
Measured: 6 weeks
Risk of malnutrition
The Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) assesses the risk of malnutrition. It is measured using patient-reported items scored numerically. Scores of 0-3 indicate low risk, 4-8 moderate risk, and ≥9 high risk of malnutrition, with higher scores reflecting greater need for nutritional intervention.
Measured: 6 weeks
Dry mouth feeling
Xerostomia Inventory (XI) Assesses the overall subjective experience and frequency of dry mouth symptoms. It is measured using a 5-point Likert scale (1-5). Higher scores indicate more frequent and severe xerostomia.
Regional Oral Dryness Inventory (RODI) Assesses the location-specific experience of oral dryness across different regions of the mouth. It is measured using a 5-point Likert scale (1-5). Higher scores indicate more severe regional oral dryness.
Measured: 6 weeks
Taste and smell function
Taste function measured with taste strips and the smell function measured with Sniffin' Sticks.
Measured: 6 weeks
Saliva secretion
Saliva secretion
Measured: 6 weeks
Body weight
Body weight
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start6 Jun 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple Negative Breast CancerStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. J. de Haan, MD, PhD, Principal investigator, University Medical Center Groningen, Dept. of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258563
- Sponsor's protocol ID
- 20862
- Acronym
- TASTY-steering
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Steering in Patients With Cancer Who Are Treated With Chemotherapy: a Multicentre Randomized Intervention Trial
- ClinicalTrials.gov ID
- NCT07258563
- Acronym / sponsor ID
- TASTY-steering / 20862
- Conditions
- Metastatic Triple Negative Breast Cancer, Metastatic Testicular Cancer, Stage II-IV Diffuse Large B Cell Lymphoma
- Keywords
- Taste Alterations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 2 Dec 2025 (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.
This is a multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands. A parallel cluster design per hospital was selected to prevent contact between participants in the same hospital who are randomised into different study arms. Such contact may result in bias as it may allow for patients in the control arm to be informed about elements of taste steering.
To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks.
Some hospitals have implemented elements of taste steering. However, these elements are focused on patients who are admitted to the hospital, and therefore only interfere to a limited extent with the present study that is directed at patients managing their taste alterations at home. Experience with the Smaakpupil tool indicates that the algorithm reaches saturation after 3-4 weeks. Therefore, an intervention period of 6 weeks has been selected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taste steering | Experimental | Behavioral: Taste steeringTo examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. |
| No intervention | No intervention | –standard of care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 and ≤70 years
- Indication to start chemotherapy for:
- Chemotherapy scheduled to start in the next 6 weeks
- Consuming solid foods and drinks is possible
- ≤50% of recommended daily intake in kcal consists of oral nutritional supplements
Key exclusion criteria (6 listed)
- Pregnancy
- Currently experiencing taste or smell problems
- Previous or current radiotherapy of head and neck region
- Enteral feeding through tube or parenteral feeding
- Participation in another clinical trial aimed at preventing or treating taste and/or smell alterations
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 |
|---|---|---|
| Taste steeringTo examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks. | Behavioural | Taste steering |
Primary outcome
Food enjoyment in appetite, hunger and sensory perception
Time frame: 6 weeks
Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) after 6 weeks of taste steering compared with standard care. The AHSP uses a 5-point Likert scale (1-5), with higher scores indicating greater appetite, hunger, or sensory changes.
8 secondary outcomes
Food enjoyment and liking
Time frame: 6 weeks
Health-related quality of life
Time frame: 6 weeks
Taste and smell alterations
Time frame: 6 weeks
Risk of malnutrition
Time frame: 6 weeks
Dry mouth feeling
Time frame: 6 weeks
Taste and smell function
Time frame: 6 weeks
Saliva secretion
Time frame: 6 weeks
Body weight
Time frame: 6 weeks
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 15 Jul 2026.
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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.
J. J. de Haan, MD, PhD principal investigator
University Medical Center Groningen, Dept. of Medical Oncology
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taste steering in people with Metastatic Triple Negative Breast Cancer and Metastatic Testicular Cancer, run by University Medical Center Groningen at 11 sites in Netherlands.
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 12 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. 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?
Contact J. J. de Haan, MD, PhD (+31 50 361 2821, j.j.de.haan@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food enjoyment in appetite, hunger and sensory perception (time frame: 6 weeks). 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 15 Jul 2026.