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NCT Number: NCT07258563

The TASTY-steering Study

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.

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Key information

Conditions

Metastatic Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Metastatic Testicular Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stage II-IV Diffuse Large B Cell Lymphoma Testicular Diseases Testicular Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Taste steering

Behavioral

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.

Primary outcomes

  1. Food enjoyment in appetite, hunger and sensory perception

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Food enjoyment and liking

    Time frame: 6 weeks

    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.

  2. Health-related quality of life

    Time frame: 6 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.

  3. Taste and smell alterations

    Time frame: 6 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.

  4. Risk of malnutrition

    Time frame: 6 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.

  5. Dry mouth feeling

    Time frame: 6 weeks

    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. Taste and smell function

    Time frame: 6 weeks

    Taste function measured with taste strips and the smell function measured with Sniffin' Sticks.

  7. Saliva secretion

    Time frame: 6 weeks

    Saliva secretion

  8. Body weight

    Time frame: 6 weeks

    Body weight

Study contacts

Contact information is provided by the study sponsor or research team.

J. J. de Haan, MD, PhD

CONTACT

[email protected]

+31 50 361 2821

M. D. Douma

CONTACT

[email protected]

+31 50 361 4603

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: TASTY-steering

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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