Actively Recruiting
The TASTY-steering Study
Led by University Medical Center Groningen · Updated on 2025-12-02
201
Participants Needed
11
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The TASTY-steering Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Scheduled to start chemotherapy for metastatic triple negative breast cancer, metastatic testicular cancer, or stage II-IV diffuse large B cell lymphoma
- Chemotherapy planned to start within the next 6 weeks
- Able to consume solid foods and drinks
- Oral nutritional supplements make up 50% or less of daily calorie intake
- Oral mucositis grade 2 or less (Common Terminology Criteria for Adverse Events, version 5.0)
- Able to follow all study procedures
- Provided written informed consent
- For intervention phase: reported subjective change in taste since starting chemotherapy
You will not qualify if you...
- Pregnancy
- Currently have taste or smell problems
- Previous or current radiotherapy to the head and neck area
- Receiving feeding through a tube or intravenous feeding
- Participating in another clinical trial targeting taste or smell changes
- Using high dose corticosteroids (more than 10 mg prednisone or equivalent per day) for over one month
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Trial Site Locations
Total: 11 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
2
Rijnstate Ziekenhuis
Arnhem, Netherlands
Not Yet Recruiting
3
Van Weel-Bethesda Ziekenhuis
Dirksland, Netherlands
Not Yet Recruiting
4
Ziekenhuisvoorzieningen Gelderse Vallei
Ede, Netherlands
Actively Recruiting
5
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
6
Martini Ziekenhuis
Groningen, Netherlands
Actively Recruiting
7
Radboud University Medical Center
Nijmegen, Netherlands
Not Yet Recruiting
8
Ikazia Ziekenhuis
Rotterdam, Netherlands
Actively Recruiting
9
Ommelander Ziekenhuis Groningen
Scheemda, Netherlands
Actively Recruiting
10
Maxima Medisch Centrum
Veldhoven, Netherlands
Not Yet Recruiting
11
Isala Klinieken
Zwolle, Netherlands
Not Yet Recruiting
Research Team
J
J. J. de Haan, MD, PhD
CONTACT
M
M. D. Douma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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