Oncological Patients, Tyrosine Kinase Inhibitor
Conditions
Keywords
Taste alterations
Brief summary
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.
Interventions
BEHAVIORALTaste 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.
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taste function | 12 weeks | Taste function measured with taste strips at baseline and after week 12 weeks of taste and smell training compared with standard care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smell function | 12 weeks | Smell function measured with Sniffin' Sticks at baseline and after week 12 of taste and smell training compared to standard care |
| Food enjoyment in appetite, hunger and sensory perception | 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. |
| Health-related quality of life | 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. |
| Taste and smell alterations | 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. |
| Risk of malnutrition | 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. |
| Dry mouth feeling | 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. |
| Saliva secretion | 12 weeks | Saliva secretion |
| Body weight | 12 weeks | Body weight |
Countries
Netherlands
Contacts
CONTACTJ. J.A. de Haan, MD, PhD
CONTACTM. D. Douma
PRINCIPAL_INVESTIGATORJ. J.A. de Haan, MD, PhD
University Medical Center Groningen
Outcome results
None listed