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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taste steering | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Food enjoyment | 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Food enjoyment and liking | Food enjoyment and food liking: questions on food enjoyment and food liking on 9-point hedonic scale | 6 weeks |
| Quality of life | Quality of life: EORTC QLQ-C30 |
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Inclusion Criteria:
Age ≥18 and ≤70 years
Indication to start chemotherapy for:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J. J. de Haan, MD, PhD | Contact | +31 50 361 2821 | j.j.de.haan@umcg.nl | |
| M. D. Douma | Contact | +31 50 361 4603 | m.d.douma@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| J. J. de Haan, MD, PhD | University Medical Center Groningen, Dept. of Medical Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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|
| 6 weeks |
| Taste and smell alterations | Taste and smell alterations: Chemotherapy-induced Taste Alteration Scale (ciTAS-NL) | 6 weeks |
| Risk of malnutrition | Risk of malnutrition: Patient-Generated Subjective Global Assessment (PG-SGA) | 6 weeks |
| Dry mouth feeling | Dry mouth feeling: Xerostomia Inventory (XI) and Regional Oral Dryness Inventory (RODI) | 6 weeks |
| Taste and smell function | Taste and smell function | 6 weeks |
| Saliva secretion | Saliva secretion | 6 weeks |
| Body weight | Body weight | 6 weeks |
| Rijnstate Ziekenhuis | Not yet recruiting | Arnhem | Netherlands |
|
| Van Weel-Bethesda Ziekenhuis | Not yet recruiting | Dirksland | Netherlands |
|
| Ziekenhuisvoorzieningen Gelderse Vallei | Recruiting | Ede | Netherlands |
|
| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
|
| Martini Ziekenhuis | Recruiting | Groningen | Netherlands |
|
| Radboud University Medical Center | Not yet recruiting | Nijmegen | Netherlands |
|
| Ikazia Ziekenhuis | Recruiting | Rotterdam | Netherlands |
|
| Ommelander Ziekenhuis Groningen | Recruiting | Scheemda | Netherlands |
|
| Maxima Medisch Centrum | Not yet recruiting | Veldhoven | Netherlands |
|
| Isala Klinieken | Not yet recruiting | Zwolle | Netherlands |
|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |