The TASTY-steering Study (TASTY-steering)

Taste Steering in Patients With Cancer Who Are Treated With Chemotherapy: a Multicentre Randomized Intervention Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Triple Negative Breast Cancer; Metastatic Testicular Cancer; Stage II-IV Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Behavioral: Taste steering

• Study Type: Interventional
• Enrollment (Estimated): 201
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M. D. Douma; Phone Number: +31 50 361 4603; Email: m.d.douma@umcg.nl
• Study Contact Backup: Name: J. J. de Haan, MD, PhD; Phone Number: +31 50 361 2821; Email: j.j.de.haan@umcg.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: K. Silverio Alonso-Duin
  • Arnhem, Netherlands
    • Not yet recruiting
    • Rijnstate Ziekenhuis
    • Contact: M. D.J.L. van der Vorst
  • Dirksland, Netherlands
    • Not yet recruiting
    • Van Weel-Bethesda Ziekenhuis
    • Contact: H. Noordzij-Nooteboom
  • Ede, Netherlands
    • Recruiting
    • Ziekenhuisvoorzieningen Gelderse Vallei
    • Contact: G. A. Velders
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: M. D. Douma; Phone Number: +31 50 361 4603; Email: m.d.douma@umcg.nl
    • Principal Investigator: J. J. de Haan, MD, PhD
    • Contact: J. J. de Haan, MD, PhD; Phone Number: +31 50 361 2821; Email: j.j.de.haan@umcg.nl
  • Groningen, Netherlands
    • Recruiting
    • Martini Ziekenhuis
    • Contact: A. W.G. van der Velden
  • Nijmegen, Netherlands
    • Not yet recruiting
    • Radboud University Medical Center
    • Contact: S. Kaal
  • Rotterdam, Netherlands
    • Recruiting
    • Ikazia Ziekenhuis
    • Contact: F. de Boer
  • Scheemda, Netherlands
    • Recruiting
    • Ommelander Ziekenhuis Groningen
    • Contact: T. Osinga-Fickweiler
  • Veldhoven, Netherlands
    • Not yet recruiting
    • Maxima Medisch Centrum
    • Contact: R. van Lieshout
  • Zwolle, Netherlands
    • Not yet recruiting
    • Isala Klinieken
    • Contact: J. W.B. de Groot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: No intervention; standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva secretion	Saliva secretion	6 weeks
Body weight	Body weight	6 weeks
Food enjoyment and liking	Food enjoyment and food liking: questions on food enjoyment and food liking on 9-point hedonic scale. Higher scores on the Food enjoyment and food liking indicate more food enjoyment and food liking.	6 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.	6 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.	6 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.	6 weeks
Dry mouth feeling	Xerostomia Inventory (XI) Assesses the overall subjective experience and frequency of dry mouth symptoms. It is measured using a 5-point Likert scale (1-5). Higher scores indicate more frequent and severe xerostomia. Regional Oral Dryness Inventory (RODI) Assesses the location-specific experience of oral dryness across different regions of the mouth. It is measured using a 5-point Likert scale (1-5). Higher scores indicate more severe regional oral dryness.	6 weeks
Taste and smell function	Taste function measured with taste strips and the smell function measured with Sniffin' Sticks.	6 weeks

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: J. J. de Haan, MD, PhD, University Medical Center Groningen, Dept. of Medical Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Taste Alterations
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Endocrine Gland Neoplasms; Gonadal Disorders; Skin Diseases; Breast Diseases; Breast Neoplasms; Testicular Diseases; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Testicular Neoplasms
• Other Study ID Numbers: 20862

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No