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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Taste and smell training
BehavioralTo 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Taste and smell trainingExperimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Taste function
Taste function measured with taste strips at baseline and after week 12 weeks of taste and smell training compared with standard care
Time frame
12 weeksSecondary outcomes
1
Smell function
Smell function measured with Sniffin' Sticks at baseline and after week 12 of taste and smell training compared to standard care
Time frame
12 weeks2
Food enjoyment in appetite, hunger and sensory perception
Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) and the Food enjoyment and food liking: questions on food enjoyment and food liking on 9-point hedonic scale at baseline and after 12 weeks of taste and smell training compared with standard care. The AHSP score is lower in presence of malnutrition. Higher scores on the Food enjoyment and food liking indicate more food enjoyment and food liking.
Time frame
12 weeks3
Health-related quality of life
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30 questionnaire) assesses quality of life. It is measured using 1-4 and 1-7 scales. Higher scores indicate better functioning and global quality of life, and worse symptoms on symptom domains.
Time frame
12 weeks4
Taste and smell alterations
The Chemotherapy-induced Taste Alteration Scale (ciTAS-NL) assesses taste and smell alterations across intensity, discomfort, and phantogeusia/parageusia domains. It is measured using a 5-point Likert scale. Higher scores indicate more severe alterations.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov