Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention
Recruiting · NCT07649681 · Interventional (participants receive a specific treatment) · Lead sponsor: Wuerzburg University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 randomized study aims to compare the effectiveness of individualized dietary recommendations (Gustabor group) with the current standard of care -general recommendations (Control group). Participants will undergo an objective assessment of taste disorders using taste strips and questionnaires. Based on the results, the Gustabor group will receive both general and specific dietary suggestions. These will be accomapnied by AI-generated recipe suggestions tailored to specific taste disorders (e.g., more cold foods in cases of metallic taste). The control group will receive the current standard: a flyer containing general dietary advice for oncology patients previously shown to be beneficial for managing taste alterations. The primary endpoint is the PG-SGA score within 12 weeks of inclusion.
Who can take part
Inclusion criteria
- Age ≥ 18
- Suffering from one of the following tumor entities: Multiple myeloma, melanoma, urogenital cancer or malignant tumor of the gastrointestinal tract
- Mainly oral nutrition
- Subjectively perceived tumor therapy-related taste disorder
- At least two clinical presentations planned within 12 weeks with a minimum interval of three weeks
- Ability to participate in nutritional intervention, including use of the online portal and implementation of recipe suggestions (e.g. resources and access to a kitchen), either independently or with third-party support (e.g. by relatives, outpatient care services).
Exclusion criteria
- Pregnancy
- Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)
- Placement in an inpatient care facility
Where it is running
6 locations listed.
- Universitätsklinikum Augsburg - Augsburg, Bavaria, Germany
- Universitätsklinikum Erlangen - Erlangen, Bavaria, Germany
- LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center - München, Bavaria, Germany
- Klinikum der Technischen Universität München (TUM Klinikum) - München, Bavaria, Germany
- Universitätsklinikum Regensburg - Regensburg, Bavaria, Germany
- Universitätsklinikum Würzburg - Würzburg, Bavaria, Germany