The TASTY-steering Study

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Metastatic Triple Negative Breast Cancer or Metastatic Testicular Cancer, or Stage II-IV Diffuse Large B Cell Lymphoma

Treatments: Behavioral: Taste steering

Study type: Interventional

Funder types: Other

Identifiers

NCT07258563

20862

Details and patient eligibility

About

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.

Enrollment: 201 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Taste steering

Experimental group

Description:

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.

Treatment:

Behavioral: Taste steering

No intervention

No Intervention group

Description:

standard of care