Gustabor Phase 1 - AI-based Creation of a Nutritional Plan to Compensate for Chemotherapy-induced Taste Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWuerzburg University Hospital
About this trial
The study investigates taste disorders that commonly occur during or after cancer treatment, often leading to issues such as malnutrition and treatment discontinuation. Although many non-pharmacological recommendations exist, it is unclear which methods are suitable for which individuals. This pilot study aims to use an AI-based, or rule-driven system to generate personalized recommendations based on patients' specific impairments and taste disorder. For the pilot study, the AI will be trained on recipes to create individualized meal plans, helping to identify foods that are likely to be better. The primary endpoint is the assessment of the nutritional intervention as helpful at the second visit within 12 weeks of inclusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18
Suffering from one of the following tumor entities: Multiple myeloma or malignant tumor of the gastrointestinal tract
Mainly oral nutrition
Subjectively perceived tumor therapy-related taste disorder
Disqualifiers
Pregnancy
Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)
Placement in an inpatient care facility
Trial design
Design model
Single group
Treatments tested in this trial
Gustabor server
Other interventionAI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder
Treatment groups
51 Participants
are divided into 1 treatment groupGroup A: Intervention arm All patients within the study are included in the intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient rating of the nutritional intervention as helpful
Rating of the overall nutritional intervention as helpful at the second visit within 12 weeks after inclusion my means of questionnaire. Rating using a 3-point scale: "Tried it and it didn't help", "Was somewhat helpful" and "Was very helpful".
Time frame
Within 12 weeks of inclusionSecondary outcomes
1
Patient-generated Subjective Global Assessment (PG-SGA) Score
PG-SGA measures four key areas: weight history, including recent unintentional weight loss; the presence of nutrition-impacting symptoms such as nausea, taste changes, and appetite loss; current food intake compared to normal levels; and functional status, which measures the ability to perform daily activities. Based on the responses, a numeric score is calculated, with higher scores indicating a greater risk of malnutrition and the need for dietary intervention.
Time frame
Within 12 weeks of inclusion2
Identification of measures that were perceived as helpful
Feedback rating regarding the individual tested measures as helpful / not helpful. Rating using a 3-point scale: "Tried it and it didn't help", "Was somewhat helpful" and "Was very helpful".
Time frame
Within 12 weeks of inclusion3
Exploration of correlations between measures and taste perception, tumor type and ongoing tumor therapy
Correlation of the 3-point rated individual measures with individual taste perceptions, tumor type and ongoing tumor therapy
Time frame
Within 12 weeks of inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wuerzburg University Hospital
Lead sponsor
LMU Klinikum
Collaborator
University Hospital Regensburg
Collaborator
Source ClinicalTrials.gov