- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07258589
The TASTY-training Study (TASTY-training)
Taste and Smell Training in Patients With Cancer Who Are Treated With Tyrosine Kinase Inhibitors: a Multicentre Randomized Intervention 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: J. J.A. de Haan, MD, PhD
- Phone Number: +31 50 361 2821
- Email: j.j.de.haan@umcg.nl
Study Contact Backup
- Name: M. D. Douma
- Phone Number: +31 50 361 4603
- Email: m.d.douma@umcg.nl
Study Locations
-
-
-
Amsterdam, Netherlands
- Recruiting
- Amsterdam UMC
-
Contact:
- K. Silverio Alonso-Duin
-
Arnhem, Netherlands
- Not yet recruiting
- Rijnstate Ziekenhuis
-
Contact:
- M. D.J.L. van der Vorst
-
Dirksland, Netherlands
- Not yet recruiting
- Van Weel-Bethesda Ziekenhuis
-
Contact:
- H. Noordzij-Nooteboom
-
Ede, Netherlands
- Recruiting
- Ziekenhuisvoorzieningen Gelderse Vallei
-
Contact:
- G. A. Velders
-
Groningen, Netherlands, 9713 GZ
- Recruiting
- University Medical Center Groningen
-
Contact:
- J. J.A. de Haan, MD, PhD
- Phone Number: +31 50 361 2821
- Email: j.j.de.haan@umcg.nl
-
Contact:
- M. D. Douma
- Phone Number: +31 50 361 4603
- Email: m.d.douma@umcg.nl
-
Principal Investigator:
- J. J. de Haan, MD, PhD
-
Groningen, Netherlands
- Recruiting
- Martini Ziekenhuis
-
Contact:
- A. W.G. van der Velden
-
Nijmegen, Netherlands
- Not yet recruiting
- Radboud University Medical Center
-
Contact:
- S. Kaal
-
Rotterdam, Netherlands
- Recruiting
- Ikazia Ziekenhuis
-
Contact:
- F. de Boer
-
Scheemda, Netherlands
- Recruiting
- Ommelander Ziekenhuis Groningen
-
Contact:
- T. Osinga-Fickweiler
-
Veldhoven, Netherlands
- Not yet recruiting
- Maxima Medisch Centrum
-
Contact:
- R. van Lieshout
-
Zwolle, Netherlands
- Not yet recruiting
- Isala Klinieken
-
Contact:
- J. W.B. de Groot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: No intervention
Standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Taste function
Time Frame: 12 weeks
|
Taste function measured with taste strips at baseline and after week 12 weeks of taste and smell training compared with standard care
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: 12 weeks
|
Body weight
|
12 weeks
|
|
Smell function
Time Frame: 12 weeks
|
Smell function measured with Sniffin' Sticks at baseline and after week 12 of taste and smell training compared to standard care
|
12 weeks
|
|
Saliva secretion
Time Frame: 12 weeks
|
Saliva secretion
|
12 weeks
|
|
Food enjoyment in appetite, hunger and sensory perception
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
Health-related quality of life
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
Taste and smell alterations
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
Risk of malnutrition
Time Frame: 12 weeks
|
The Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) assesses the risk of malnutrition.
It is measured using patient-reported items scored numerically.
Scores of 0-3 indicate low risk, 4-8 moderate risk, and ≥9 high risk of malnutrition, with higher scores reflecting greater need for nutritional intervention.
|
12 weeks
|
|
Dry mouth feeling
Time Frame: 12 weeks
|
The Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) assesses the risk of malnutrition.
It is measured using patient-reported items scored numerically.
Scores of 0-3 indicate low risk, 4-8 moderate risk, and ≥9 high risk of malnutrition, with higher scores reflecting greater need for nutritional intervention.
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: J. J.A. de Haan, MD, PhD, University Medical Center Groningen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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