TASTY training to improve taste and smell for people taking tyrosine kinase inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre, non-blinded, cluster-randomised trial is being run at 12 hospitals in the Netherlands with each hospital randomised to either the training or control arm to avoid cross-contamination. Participants complete baseline measurements and repeat testing after 12 weeks; questionnaires are filled in online while taste and smell tests and saliva samples are collected at home or during routine hospital visits. The intervention arm performs a structured at-home taste and smell training program for 12 weeks, while the control arm receives usual care. Dietitians contact participants in both arms and support adherence and data collection.

Why it matters

Who can join: the full rules

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)

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Ziekenhuisvoorzieningen Gelderse Vallei
  Ede, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting
• Martini Ziekenhuis
  Groningen, Netherlands Recruiting
• Ikazia Ziekenhuis
  Rotterdam, Netherlands Recruiting
• Ommelander Ziekenhuis Groningen
  Scheemda, Netherlands Recruiting

Study contacts

• Principal investigator: J. J.A. de Haan, MD, PhD — University Medical Center Groningen
• Study coordinator: J. J.A. de Haan, MD, PhD
• Email: j.j.de.haan@umcg.nl
• Phone: +31 50 361 2821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.