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| Name | Class |
|---|---|
| LMU Klinikum | OTHER |
| University Hospital Regensburg | OTHER |
| University Hospital Erlangen | OTHER |
| University Hospital Augsburg |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gustabor Group | Experimental | Gustabor server: Receives general and specific nutrition recommendations, as well as lifestyle tips and recipes based on the patient's individual taste changes and preferences as identified by the AI based web platform |
|
| Control Group | Other | Receives the current standard recommendations for taste disorders from scientifically published measures in form of a printed-out flyer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gustabor server | Other | AI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 12 weeks of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Alexander Hann | Contact | +49 931 201 45918 | Hann_A@ukw.de | |
| Dr. med. Anna Fleischer | Contact | Fleischer_A@ukw.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Augsburg | Augsburg | Bavaria | 86156 | Germany | ||
| Universitätsklinikum Erlangen |
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| OTHER |
| TUM Klinikum | UNKNOWN |
Prospective, randomized, non-blinded intervention study
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| Standard Recommendations | Other | Flyer consisting of current standard recommendations for taste disorders from scientifically published measures |
|
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. |
| Within 12 weeks of inclusion |
| Erlangen |
| Bavaria |
| 91054 |
| Germany |
| LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center | München | Bavaria | 81377 | Germany |
| Klinikum der Technischen Universität München (TUM Klinikum) | München | Bavaria | 81675 | Germany |
| Universitätsklinikum Regensburg | Regensburg | Bavaria | 93053 | Germany |
| Universitätsklinikum Würzburg | Würzburg | Bavaria | 97080 | Germany |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D005770 | Gastrointestinal Neoplasms |
| D013651 | Taste Disorders |
| D008545 | Melanoma |
| D014565 | Urogenital Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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