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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
90
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.
Amsterdam UMC
Amsterdam, Netherlands
RECRUITINGRijnstate Ziekenhuis
Arnhem, Netherlands
NOT_YET_RECRUITINGVan Weel-Bethesda Ziekenhuis
Dirksland, Netherlands
NOT_YET_RECRUITINGZiekenhuisvoorzieningen Gelderse Vallei
Ede, Netherlands
RECRUITINGUniversity Medical Center Groningen
Groningen, Netherlands
RECRUITINGMartini Ziekenhuis
Groningen, Netherlands
RECRUITINGRadboud University medical Center
Nijmegen, Netherlands
NOT_YET_RECRUITINGIkazia Ziekenhuis
Rotterdam, Netherlands
RECRUITINGOmmelander Ziekenhuis Groningen
Scheemda, Netherlands
RECRUITINGMaxima Medisch Centrum
Veldhoven, Netherlands
NOT_YET_RECRUITING...and 1 more locations
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Risk of malnutrition
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.
Time frame: 12 weeks
Dry mouth feeling
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.
Time frame: 12 weeks
Saliva secretion
Saliva secretion
Time frame: 12 weeks
Body weight
Body weight
Time frame: 12 weeks
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