| NCT ID | NCT07258563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Metastatic Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 201 participants |
| Start Date | 2025-06-06 |
| 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 201 participants in total. It began in 2025-06-06 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
This is 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 steering. To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering 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. Some hospitals have implemented elements of taste steering. However, these elements are focused on patients who are admitted to the hospital, and therefore only interfere to a limited extent with the present study that is directed at patients managing their taste alterations at home. Experience with the Smaakpupil tool indicates that the algorithm reaches saturation after 3-4 weeks. Therefore, an intervention period of 6 weeks has been selected.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 and ≤70 years * Indication to start chemotherapy for: * Metastatic triple negative breast cancer * Metastatic testicular cancer * Stage II-IV diffuse large B cell lymphoma * Chemotherapy scheduled to start in the next 6 weeks * Consuming solid foods and drinks is possible * ≤50% of recommended daily intake in kcal consists 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 * For the intervention phase only: subjective change in taste since start of chemotherapy Exclusion Criteria: * Pregnancy * Currently experiencing taste or smell problems * 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. de Haan, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen, Dept. of Medical Oncology
Frequently Asked Questions
Who can join the NCT07258563 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Metastatic Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07258563 currently recruiting?
Yes, NCT07258563 is actively recruiting participants. Contact the research team at j.j.de.haan@umcg.nl for enrollment information.
Where is the NCT07258563 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 NCT07258563 clinical trial?
NCT07258563 is sponsored by University Medical Center Groningen. The principal investigator is J. J. de Haan, MD, PhD at University Medical Center Groningen, Dept. of Medical Oncology. The trial plans to enroll 201 participants.
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