Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07258563

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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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

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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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