Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention
GustaborRCT
1 other identifier
interventional
198
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 16, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
June 26, 2026
June 1, 2026
6 months
June 10, 2026
June 23, 2026
Conditions
Outcome Measures
Primary 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.
Within 12 weeks of inclusion
Secondary Outcomes (2)
Identification of measures that were perceived as helpful
Within 12 weeks of inclusion
Correlation of PG-SGA progression (PG-SGA Questionnaire) with individual taste perceptions (taste strips), tumor type and ongoing tumor therapy (questionnaire)
Within 12 weeks of inclusion
Study Arms (2)
Gustabor Group
EXPERIMENTALGustabor 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
Control Group
OTHERReceives the current standard recommendations for taste disorders from scientifically published measures in form of a printed-out flyer.
Interventions
AI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder
Flyer consisting of current standard recommendations for taste disorders from scientifically published measures
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Pregnancy
- Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)
- Placement in an inpatient care facility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuerzburg University Hospitallead
- LMU Klinikumcollaborator
- University Hospital Regensburgcollaborator
- University Hospital Erlangencollaborator
- University Hospital Augsburgcollaborator
- TUM Klinikumcollaborator
Study Sites (6)
Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center
München, Bavaria, 81377, Germany
Klinikum der Technischen Universität München (TUM Klinikum)
München, Bavaria, 81675, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 16, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share