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The TASTY-steering Study

RecruitingNAAges 18 Years - 70 YearsAllUniversity Medical Center Groningen
NCT07258563 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 coll

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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).
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What it tests

  • Taste steering
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Where

11 sites
Amsterdam UMC
Amsterdam, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Van Weel-Bethesda Ziekenhuis
Dirksland, Netherlands
Ziekenhuisvoorzieningen Gelderse Vallei
Ede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Ikazia Ziekenhuis
Rotterdam, Netherlands

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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