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ID
Source
Brief title
Health condition
Childhood cancer patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is feasibility of the study. Therefore we will test whether the lower age range is suitable to be tested. If not, for our next studies we will increase the lower age limit. The number of patients fully completing the study is the main endpoint.
Secondary outcome
- Smell function
- Taste function
- Subjective smell and taste function (questionnaire)
- Papillae density
- Eating behaviour
Background summary
Children with cancer experience chemosensory changes (i.e., changes in their sense of taste and smell) during the course of treatment. Irradiation of head and neck, and administration of chemotherapeutic agents induce these changes. This is an often overlooked but still important treatment symptom as it contributes to poor food intake which in turn may cause malnutrition and affect prognosis. The central aim of this project is to elucidate causes and consequences of chemosensory changes in childhood cancer patients. The reasons for examining children with cancer (as opposed to adults) are that (1) there is very little known of the impact cancer treatment has on children’s sense of taste and smell and how this affects food intake and food preferences directly and on the longer term; (2) dietary habits and flavour preferences are still developing in children and thus the impact of therapy induced dysfunctional taste and smell is, presumably, much larger in childhood cancer patients.
Study objective
Smell function, taste function, and papillae density will decrease in childhood cancer patients during chemotherapy compared to: 1) The period before chemotherapy, 2) Controls (siblings).
Study design
Patients: measurements (smell, taste, papillae density) will take place during clinical admission to the hospital, at least once in every patient.
- Measurement 1: before a cycle of chemotherapy (day 1), in order to explore whether measurements are feasible.
- Measurement 2: at the end of the cycle of chemotherapy, only if the first measurement can be considered as feasible.
Controls: one measurement.
Inclusion criteria
Inclusion criteria patients:
- Children, 6-17 years old
- Currently undergoing chemotherapy
Inclusion criteria controls (siblings):
- Children, 6-17 years old
Exclusion criteria
Exclusion criteria patients:
- Children with isolated congenital anosmia (ICA; a complete loss of smell)
- Children ≤ 5 years
- Children and parents that do not understand the Dutch language
- Children with a self-reported allergy to quinine
- Children with severe oral mucositis (treatment-induced ulceration of the mucosa, blis-tered tongue, and absence of saliva)
Exclusion criteria controls:
- Children with isolated congenital anosmia (ICA; a complete loss of smell)
- Children ≤ 5 years
- Children and parents that do not understand the Dutch language
- Children with a self-reported allergy to quinine
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7533 |
| Other | METC UMCG : METC2018/621 |