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Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention

NCT07649681 · Wuerzburg University Hospital
In plain English

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About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 198 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-24
Estimated completion: 2026-12-31
Last updated: 2026-08-20
Interventions
Other: Gustabor serverOther: Standard Recommendations
Primary outcomes
  • Patient-generated Subjective Global Assessment (PG-SGA) Score (Within 12 weeks of inclusion)
Sponsor
Wuerzburg University Hospital · other
With: LMU Klinikum, University Hospital Regensburg, University Hospital Erlangen, University Hospital Augsburg, TUM Klinikum
Contacts & investigators
ContactProf. Dr. med. Alexander Hann · contact · Hann_A@ukw.de · +49 931 201 45918
ContactDr. med. Anna Fleischer · contact · Fleischer_A@ukw.de
All locations (6)
Universitätsklinikum AugsburgNot Yet Recruiting
Augsburg, Bavaria, Germany
Universitätsklinikum ErlangenRecruiting
Erlangen, Bavaria, Germany
LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer CenterRecruiting
München, Bavaria, Germany
Klinikum der Technischen Universität München (TUM Klinikum)Not Yet Recruiting
München, Bavaria, Germany
Universitätsklinikum RegensburgNot Yet Recruiting
Regensburg, Bavaria, Germany
Universitätsklinikum WürzburgNot Yet Recruiting
Würzburg, Bavaria, Germany
Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention · TrialPath