The TASTY-training Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Who Are Treated With Tyrosine Kinase Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Taste and smell training

Intervention Type BEHAVIORAL

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.

No intervention

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No