RecruitingNot ApplicableNCT07258589

The TASTY-training Study

Taste and Smell Training in Patients With Cancer Who Are Treated With Tyrosine Kinase Inhibitors: a Multicentre Randomized Intervention Trial


Sponsor

University Medical Center Groningen

Enrollment

90 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 and smell training. To examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention 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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

  • Age ≥18 and ≤70 years
  • Intention of being treated with tyrosine kinase inhibitors for next 12 weeks.
  • Experiencing taste alterations after starting treatment with tyrosine kinase inhibitors
  • Consuming solid foods and drinks is possible
  • ≤50% of recommended daily intake in kcal consisting 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

Exclusion Criteria6

  • Pregnancy
  • History of taste, smell, or saliva production dysfunction before treatment with tyrosine kinase inhibitors
  • 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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Interventions

BEHAVIORALTaste and smell training

To examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention 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.


Locations(11)

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

Ommelander Ziekenhuis Groningen

Scheemda, Netherlands

Maxima Medisch Centrum

Veldhoven, Netherlands

Isala Klinieken

Zwolle, Netherlands

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NCT07258589