Metastatic Testicular Cancer, Metastatic Triple Negative Breast Cancer, Stage II-IV Diffuse Large B Cell Lymphoma
Conditions
Keywords
Taste Alterations
Brief 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.
Interventions
BEHAVIORALTaste 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.
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food enjoyment in appetite, hunger and sensory perception | 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
| Measure | Time frame | Description |
|---|---|---|
| Food enjoyment and liking | 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. |
| Health-related quality of life | 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. |
| Taste and smell alterations | 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. |
| Risk of malnutrition | 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. |
| Dry mouth feeling | 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. |
| Taste and smell function | 6 weeks | Taste function measured with taste strips and the smell function measured with Sniffin' Sticks. |
| Saliva secretion | 6 weeks | Saliva secretion |
| Body weight | 6 weeks | Body weight |
Countries
Netherlands
Contacts
CONTACTJ. J. de Haan, MD, PhD
CONTACTM. D. Douma
PRINCIPAL_INVESTIGATORJ. J. de Haan, MD, PhD
University Medical Center Groningen, Dept. of Medical Oncology
Outcome results
None listed