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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: GI Cancer; Melanoma (Skin Cancer); Multiple Myeloma (MM); Taste Disorder; Urogenital Cancers
• Intervention / Treatment: Other: Gustabor server; Other: Standard Recommendations

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Dr. med. Alexander Hann; Phone Number: +49 931 201 45918; Email: Hann_A@ukw.de
• Study Contact Backup: Name: Dr. med. Anna Fleischer; Email: Fleischer_A@ukw.de

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Universitätsklinikum Augsburg
    • Erlangen, Bavaria, Germany, 91054
      • Universitätsklinikum Erlangen
    • München, Bavaria, Germany, 81377
      • LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center
    • München, Bavaria, Germany, 81675
      • Klinikum der Technischen Universität München (TUM Klinikum)
    • Regensburg, Bavaria, Germany, 93053
      • Universitatsklinikum Regensburg
    • Würzburg, Bavaria, Germany, 97080
      • Universitätsklinikum Würzburg
      • Contact: Prof. Dr. med. Alexander Hann; Phone Number: +49 931 201 45918; Email: Hann_A@ukw.de
      • Contact: Dr. med. Anna Fleischer; Email: Fleischer_A@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Gustabor server; AI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder
Other: Control Group; Receives the current standard recommendations for taste disorders from scientifically published measures in form of a printed-out flyer.	Other: Standard Recommendations; Flyer consisting of current standard recommendations for taste disorders from scientifically published measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	Within 12 weeks of inclusion
Correlation of PG-SGA progression with individual taste perceptions, tumor type and ongoing tumor therapy	Correlation of PG-SGA progression with individual taste perceptions, tumor type and ongoing tumor therapy	Within 12 weeks of inclusion

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: LMU Klinikum; University Hospital Erlangen; University Hospital Regensburg; University Hospital Augsburg; Munich University Hospital Rechts der Isar

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Immune System Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Hematologic Diseases; Skin Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Sensation Disorders; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Nevi and Melanomas; Skin Neoplasms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Gastrointestinal Neoplasms; Multiple Myeloma; Melanoma; Urogenital Neoplasms; Taste Disorders
• Other Study ID Numbers: Gustabor2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No