The TASTY-training Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Medical Center Groningen
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Taste and smell training
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov