GI Cancer, Melanoma (Skin Cancer), Multiple Myeloma (MM), Taste Disorder, Urogenital Cancers
Conditions
Brief summary
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
OTHERGustabor server
AI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder
Flyer consisting of current standard recommendations for taste disorders from scientifically published measures
Sponsors
Wuerzburg University Hospital
LMU Klinikum
University Hospital Regensburg
University Hospital Erlangen
University Hospital Augsburg
TUM Klinikum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, randomized, non-blinded intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-generated Subjective Global Assessment (PG-SGA) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of measures that were perceived as helpful | 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". |
| Correlation of PG-SGA progression (PG-SGA Questionnaire) with individual taste perceptions (taste strips), tumor type and ongoing tumor therapy (questionnaire) | 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. |
Countries
Germany
Contacts
CONTACTProf. Dr. med. Alexander Hann
CONTACTDr. med. Anna Fleischer
Outcome results
None listed