Menu
Recruiting NCT07258589

The TASTY-training Study

No phase Interventional Oncological Patients Tyrosine Kinase Inhibitor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Taste and smell training.
Who it may be relevant to
Registry conditions: Oncological Patients, Tyrosine Kinase Inhibitor. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • Taste function [Time frame: 12 weeks]
Secondary outcome measures (8)
  • Smell function [Time frame: 12 weeks]
  • Food enjoyment in appetite, hunger and sensory perception [Time frame: 12 weeks]
  • Health-related quality of life [Time frame: 12 weeks]
  • Taste and smell alterations [Time frame: 12 weeks]
  • Risk of malnutrition [Time frame: 12 weeks]
  • Dry mouth feeling [Time frame: 12 weeks]
  • Saliva secretion [Time frame: 12 weeks]
  • Body weight [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 11 centers
  • Amsterdam UMC — Amsterdam
  • Rijnstate Ziekenhuis — Arnhem
  • Van Weel-Bethesda Ziekenhuis — Dirksland
  • Ziekenhuisvoorzieningen Gelderse Vallei — Ede
  • University Medical Center Groningen — Groningen
  • Martini Ziekenhuis — Groningen
  • Radboud University medical Center — Nijmegen
  • Ikazia Ziekenhuis — Rotterdam
  • … and 3 more centers

Identifiers

NCT: NCT07258589 · 20901

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗