R43.2
Conditions
Interventions
Group 1: Quantitative analysis:
Intervention group (patients with taste disorder (<9 points))
- Individual nutritional counseling (30-45 minutes)
- Smell and taste training (30 minutes)
- Provision
Sponsors
Universitäres Klinikum Hamburg- Eppendorf (UKE) - Hubertus Wald Tumorzentrum - Universitäres Cancer Center Hamburg (UCC Hamburg)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with an objective taste disorder (measured using taste strips "Taste Strips") with a point score <9 points - Patients with active cancer receiving outpatient chemotherapy including taxanes, platinum derivatives, athracyclines and / or antimetabolites - Age <18 years - existing written declaration of consent
Exclusion criteria
Exclusion criteria: - Presence of a genetic metabolic disorder - Treatment / previous treatment for an eating disorder (anorexia, bulimia, binge eating) - Parenteral nutrition, enteral supplementary food (food via PEG or PEJ) or with high-calorie drinking food (if> 50% of the energy requirement is covered by drinking food) under therapy for tumor cachexia - Radiation in the head and neck area - pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the quantitative analysis is the improvement of the objective taste perception by 2 taste strip points at week 12 in at least 50% of the patients from the intervention group compared to the control group. The primary endpoint of the qualitative analysis is to identify specific needs and reasons for participation or refusal to participate in the TASTE II trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of the quantitative analysis: - Improvement of the objective taste perception by 2 points at week 52 in at least 50% of the patients in the intervention group compared to the control group - Improvement of the objective recognition of "salty", "sweet", "sour" and "bitter" (measured with taste strips "Taste Strips") compared to the control group - Improvement of the subjective taste perception (measured by means of the anamnesis questionnaire according to Prof. Hummel) compared to the control group - Recording of nutritional status (measured using PG-SGA Short Form) - Assessment of the malnutrition risk (measured using the Malnutrition Universal Screening Tool (MUST)) - Feasibility and acceptance of taste and smell training - Recording of body composition (muscle and fat mass, phase angle) (measured using bioimpedance analysis (BIA) measurement) (center-specific) - Recording of biochemical parameters: zinc, selenium, CrP (C-reactive protein), glucose, albumin - Recording of the quality of life as well as disease and therapy-related symptoms of all study patients (measured by EORTC-C30, FATIQUE questionnaire, polyneuropathy questionnaire) Secondary endpoints of the qualitative analysis: - Collection of data of age, gender, diagnosis, form of treatment - Collection of data of the occurrence of (past) side effects/needs - Collection of data of interest in studies/nutritional studies and their content | — |
Countries
Germany
Contacts
Public ContactJulia von Grundherr
Universitäres Klinikum Hamburg- Eppendorf (UKE) - Hubertus Wald Tumorzentrum - Universitäres Cancer Center Hamburg (UCC Hamburg)
Outcome results
None listed