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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWuerzburg University Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Pregnancy

Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)

Placement in an inpatient care facility

Trial design

Treatments tested in this trial

  • Gustabor server
  • Standard Recommendations

Treatment groups

198 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wuerzburg University Hospital

Lead sponsor

LMU Klinikum

Collaborator

University Hospital Regensburg

Collaborator

University Hospital Erlangen

Collaborator

University Hospital Augsburg

Collaborator

TUM Klinikum

Collaborator