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

Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Gustabor server

    Other intervention

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

  • Standard Recommendations

    Other intervention

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

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Gustabor GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

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.

Time frame
Within 12 weeks of inclusion

Secondary outcomes

1

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".

Time frame
Within 12 weeks of inclusion
2

Correlation of PG-SGA progression (PG-SGA Questionnaire) with individual taste perceptions (taste strips), tumor type and ongoing tumor therapy (questionnaire)

Correlation of PG-SGA total score progression with individual taste perception, tumor type, and ongoing tumor therapy. The PG-SGA total score is assessed at both visits using the Scored Patient-Generated Subjective Global Assessment (PG-SGA) questionnaire and reflects the patient's nutritional status. Individual taste perception is measured using the Taste Strips and the corresponding rating scheme provided by Burghart Messtechnik. Tumor type (melanoma, multiple myeloma, gastrointestinal tumors, and urogenital tumors) as well as ongoing tumor therapy (chemotherapy, radiotherapy, and immunotherapy) are assessed using a questionnaire.

Time frame
Within 12 weeks of inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wuerzburg University Hospital

Lead sponsor

LMU Klinikum

Collaborator

University Hospital Regensburg

Collaborator

University Hospital Erlangen

Collaborator

University Hospital Augsburg

Collaborator

TUM Klinikum

Collaborator