| NCT ID | NCT07258589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Oncological Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-11-10 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
J. J.A. de Haan, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT07258589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Oncological Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07258589 currently recruiting?
Yes, NCT07258589 is actively recruiting participants. Contact the research team at j.j.de.haan@umcg.nl for enrollment information.
Where is the NCT07258589 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Arnhem, Netherlands, Dirksland, Netherlands, Ede, Netherlands and 7 additional locations.
Who is sponsoring the NCT07258589 clinical trial?
NCT07258589 is sponsored by University Medical Center Groningen. The principal investigator is J. J.A. de Haan, MD, PhD at University Medical Center Groningen. The trial plans to enroll 90 participants.