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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Rijnstate Ziekenhuis
NOT_YET_RECRUITING
Arnhem
Van Weel-Bethesda Ziekenhuis
NOT_YET_RECRUITING
Dirksland
Ziekenhuisvoorzieningen Gelderse Vallei
RECRUITING
Ede
Martini Ziekenhuis
RECRUITING
Groningen
University Medical Center Groningen
RECRUITING
Groningen
Radboud University Medical Center
NOT_YET_RECRUITING
Nijmegen
Ikazia Ziekenhuis
RECRUITING
Rotterdam
Ommelander Ziekenhuis Groningen
RECRUITING
Scheemda
Maxima Medisch Centrum
NOT_YET_RECRUITING
Veldhoven
Isala Klinieken
NOT_YET_RECRUITING
Zwolle
Contact Information
Primary
J. J. de Haan, MD, PhD
j.j.de.haan@umcg.nl
+31 50 361 2821
Backup
M. D. Douma
m.d.douma@umcg.nl
+31 50 361 4603
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2028-07
Participants
Target number of participants: 201
Treatments
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.
No_intervention: No intervention
standard of care
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov

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