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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Germany
Universitätsklinikum Augsburg
NOT_YET_RECRUITING
Augsburg
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Klinikum der Technischen Universität München (TUM Klinikum)
NOT_YET_RECRUITING
München
LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center
RECRUITING
München
Universitätsklinikum Regensburg
NOT_YET_RECRUITING
Regensburg
Universitätsklinikum Würzburg
NOT_YET_RECRUITING
Würzburg
Contact Information
Primary
Prof. Dr. med. Alexander Hann
Hann_A@ukw.de
+49 931 201 45918
Backup
Dr. med. Anna Fleischer
Fleischer_A@ukw.de
Time Frame
Start Date: 2026-07-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 198
Treatments
Experimental: Gustabor Group
Gustabor server: Receives general and specific nutrition recommendations, as well as lifestyle tips and recipes based on the patient's individual taste changes and preferences as identified by the AI based web platform
Other: Control Group
Receives the current standard recommendations for taste disorders from scientifically published measures in form of a printed-out flyer.
Related Therapeutic Areas
Sponsors
Collaborators: TUM Klinikum, University Hospital Regensburg, University Hospital Erlangen, LMU Klinikum, University Hospital Augsburg
Leads: Wuerzburg University Hospital

This content was sourced from clinicaltrials.gov