Gustabor Phase 1 - AI-based Creation of a Nutritional Plan to Compensate for Chemotherapy-induced Taste Disorders

NCT07040189 | Not Yet Recruiting

• 1 other identifier: Gustabor1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

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 pilot study aims to use an AI-based, or rule-driven system to generate personalized recommendations based on patients' specific impairments and taste disorder. For the pilot study, the AI will be trained on recipes to create individualized meal plans, helping to identify foods that are likely to be better. The primary endpoint is the assessment of the nutritional intervention as helpful at the second visit within 12 weeks of inclusion.

Conditions

Multiple Myeloma; GI Cancer; Taste Disorders

Keywords

taste disorders; AI

Outcome Measures

Primary Outcomes (1)

• Patient rating of the nutritional intervention as helpful

  Rating of the overall nutritional intervention as helpful at the second visit within 12 weeks after inclusion my means of questionnaire. 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

Secondary Outcomes (3)

• Patient-generated Subjective Global Assessment (PG-SGA) Score

  Within 12 weeks of inclusion

• Identification of measures that were perceived as helpful

  Within 12 weeks of inclusion

• Exploration of correlations between measures and taste perception, tumor type and ongoing tumor therapy

  Within 12 weeks of inclusion

Study Arms (1)

Intervention arm All patients within the study are included in the intervention arm

EXPERIMENTAL

Gustabor server - AI based web platform providing print-out of individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder

Other: Gustabor server

Interventions

Gustabor server OTHER

AI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder

Intervention arm All patients within the study are included in the intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Suffering from one of the following tumor entities: Multiple myeloma 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• LMU Klinikum: collaborator
• University Hospital Regensburg: collaborator

Study Sites (3)

LMU Klinikum

Munich, Bavaria, 81377, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma; Gastrointestinal Neoplasms; Taste Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander Hann, Prof. Dr. med.

CONTACT

+49 931 201 45918; Hann_A@ukw.de

Anna Fleischer, Dr. med.

CONTACT

Fleischer_A@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, non-blinded intervention study

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 27, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

DE (3)