patients with cancer
Conditions
Interventions
Group 1: Placebo 1: gelatine based CuraBlend PZN 1929012 raspberry-vanilla flavour
Group 2: Placebo 2: vegane, anhydrous Lozenge, without PZN, lemon-vanilla flavour
Sponsors
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Eligibility
Sex/Gender
All
Age
13 Months to No maximum
Inclusion criteria
Inclusion criteria: Confirmed underlying oncological disease according to ICCC classification Active treatment or follow-up care at Mainz University Medical Center (pediatric oncology) Cancer treatment already started (chemotherapy/radiotherapy and/or surgery) Written consent of parents or legal guardians, patients For adolescents aged 16 and over: additional written consent required Age-appropriate information and assent (consent) for children aged 6 and over Sufficient German language skills for the child and/or legal guardian(s) Medical assessment as suitable for participation in the study No indication of end-stage disease (no terminal phase)
Exclusion criteria
Exclusion criteria: Allergies or intolerances to the components of the 3D-printed placebo formulations Acute therapy-related toxicity = grade 3 (e.g., mucositis, nausea, infections) End stage of the disease (terminal phase) Lack of written consent from legal guardians or patients (aged 16 and over) Lack of capacity to give consent on the part of parents or patients Lack of age-appropriate consent for children over 6 years of age Insufficient knowledge of German (child or legal guardian) such that information and questionnaires cannot be understood Medical assessment as unsuitable for participation (e.g., medical or psychosocial reasons)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the acceptance of the 3D-printed oral placebo formulation and is assessed based on the answer to the question “Would you/the child take this tablet again?” Time of assessment: This question is asked once immediately after taking the respective formulation (vanilla-raspberry or vanilla-lemon) during the one-time study participation. Measurement method: The assessment is made verbally or in writing by the study participant or by the legal guardian in the case of youngest children. The answer is documented dichotomously (yes/no). The answer is documented by study personnel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the smell, taste, aftertaste, swallowability, and mouthfeel of the new formulation | — |
Countries
Germany
Contacts
Public ContactAlexandra Russo
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Outcome results
None listed