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NCT Number: NCT07649681

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

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.

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Key information

Conditions

Multiple Myeloma (MM) Blood Protein Disorders Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications GI Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Melanoma (Skin Cancer) Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Nervous System Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Nevi and Melanomas Paraproteinemias Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Taste Disorder Taste Disorders Urogenital Cancers Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Augsburg, Augsburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gustabor server

Other

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

Standard recommendations

Other

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

Primary outcomes

  1. Patient-generated Subjective Global Assessment (PG-SGA) Score

    Time frame: Within 12 weeks of inclusion

    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.

Secondary outcomes

  1. Identification of measures that were perceived as helpful

    Time frame: Within 12 weeks of inclusion

    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".

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. med. Anna Fleischer

CONTACT

[email protected]

Prof. Dr. med. Alexander Hann

CONTACT

[email protected]

+49 931 201 45918

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • LMU Klinikum
  • TUM Klinikum
  • University Hospital Augsburg
  • University Hospital Erlangen
  • University Hospital Regensburg

Registry information

Acronym: GustaborRCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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