NCT07258563

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jun 2025Jul 2028

Study Start

First participant enrolled

June 6, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 15, 2026

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

November 20, 2025

Last Update Submit

July 13, 2026

Conditions

Keywords

Taste Alterations

Outcome Measures

Primary Outcomes (1)

  • Food enjoyment in appetite, hunger and sensory perception

    Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) after 6 weeks of taste steering compared with standard care. The AHSP uses a 5-point Likert scale (1-5), with higher scores indicating greater appetite, hunger, or sensory changes.

    6 weeks

Secondary Outcomes (8)

  • Food enjoyment and liking

    6 weeks

  • Health-related quality of life

    6 weeks

  • Taste and smell alterations

    6 weeks

  • Risk of malnutrition

    6 weeks

  • Dry mouth feeling

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Taste steering

EXPERIMENTAL

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.

Behavioral: Taste steering

No intervention

NO INTERVENTION

standard of care

Interventions

Taste steeringBEHAVIORAL

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.

Taste steering

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Rijnstate Ziekenhuis

Arnhem, Netherlands

NOT YET RECRUITING

Van Weel-Bethesda Ziekenhuis

Dirksland, Netherlands

NOT YET RECRUITING

Ziekenhuisvoorzieningen Gelderse Vallei

Ede, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

NOT YET RECRUITING

Ikazia Ziekenhuis

Rotterdam, Netherlands

RECRUITING

Ommelander Ziekenhuis Groningen

Scheemda, Netherlands

RECRUITING

Maxima Medisch Centrum

Veldhoven, Netherlands

NOT YET RECRUITING

Isala Klinieken

Zwolle, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsTesticular Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Study Officials

  • J. J. de Haan, MD, PhD

    University Medical Center Groningen, Dept. of Medical Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

J. J. de Haan, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

June 6, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 15, 2026

Record last verified: 2025-09

Locations