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Not yet recruiting NCT07649681

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

No phase Interventional Multiple Myeloma (MM) GI Cancer Taste Disorder Melanoma (Skin Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gustabor server, Standard Recommendations.
Who it may be relevant to
Registry conditions: Multiple Myeloma (MM), GI Cancer, Taste Disorder, Melanoma (Skin Cancer). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 Standard Recommendations
    Flyer consisting of current standard recommendations for taste disorders from scientifically published measures

Primary outcome measures

  • Patient-generated Subjective Global Assessment (PG-SGA) Score [Time frame: Within 12 weeks of inclusion]
Secondary outcome measures (2)
  • Identification of measures that were perceived as helpful [Time frame: 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) [Time frame: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Germany · 6 centers
  • Universitätsklinikum Augsburg — Augsburg
  • Universitätsklinikum Erlangen — Erlangen
  • LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center — München
  • Klinikum der Technischen Universität München (TUM Klinikum) — München
  • Universitätsklinikum Regensburg — Regensburg
  • Universitätsklinikum Würzburg — Würzburg

Identifiers

NCT: NCT07649681 · Gustabor2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗