Multiple MyelomaGustaborPilotNCT07040189
Gustabor Phase 1 - AI-based Creation of a Nutritional Plan to Compensate for Chemotherapy-induced Taste Disorders
A study testing Gustabor server in people with Multiple Myeloma and GI Cancer, run by Wuerzburg University Hospital at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, GI Cancer, Taste Disorders
- What is being tested?
- Gustabor server
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesGermany
- Study dates
- 25 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Suffering from one of the following tumor entities: Multiple myeloma 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).
Who cannot join
- Pregnancy
- Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)
- Placement in an inpatient care facility
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Fleischer, Dr. med. contact
Germany3 sites, 2 recruiting
- Completed
LMU Klinikum
Munich, Bavaria, 81377
- Recruiting
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053
- Recruiting
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Alexander Hann, Prof. Dr. med., +49 931 201 45918, Hann_A@ukw.de
Anna Fleischer, Dr. med., Fleischer_A@ukw.de
About this study
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 pilot study aims to use an AI-based, or rule-driven system to generate personalized recommendations based on patients' specific impairments and taste disorder. For the pilot study, the AI will be trained on recipes to create individualized meal plans, helping to identify foods that are likely to be better. The primary endpoint is the assessment of the nutritional intervention as helpful at the second visit within 12 weeks of inclusion.
Read the detailed description
The primary goal of this pilot study is to evaluate the feasibility and perceived helpfulness of a web application using AI-supported, personalized dietary recommendations for patients experiencing taste disorders during or after cancer therapy. The primary endpoint is the assessment of the nutritional intervention as helpful at the second visit within 12 weeks of inclusion.
The study is a prospective, single-arm, non-blinded intervention study with a maximum duration of 12 weeks for individual participants. Participants will be identified on the ward or in outpatient centers during their clinical treatment routine. Study measures and progress assessments will also only take place during the chemotherapy administrations planned as part of the clinical treatment routine or during the follow-up visits.
Data is entered into the Gustabor portal together with study staff. Initially, anthropometric data, eating habits, taste experiences, and taste alterations are recorded via questionnaires. Taste thresholds for sweet, sour, salty, bitter, and umami are then assessed using taste strips. Based on these inputs, an AI system generates personalized recipe recommendations as well as recommendations for actions (e.g., cold meals recommended in case of metallic taste), which are printed and reviewed with the participant. Additionally, participants receive a flyer containing general dietary advice for oncology patients. At the start of the study and again after a period of at least three and up to twelve weeks (timed to fit clinical routines), the Patient-Generated Subjective Global Assessment (PG-SGA) score will be recorded, evaluating weight, symptoms, dietary intake, and physical activity. At the second visit it will be assessed which recommendations were implemented and how helpful they were perceived overall (primary endpoint) and in detail.
- Conditions
- Multiple Myeloma, GI Cancer, Taste Disorders
- Being tested
- Gustabor server
- Keywords
- taste disorders, AI
- Medical subject headings
- Multiple Myeloma, Gastrointestinal Neoplasms, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gustabor serverOther
AI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm All patients within the study are included in the intervention arm | Experimental | Gustabor server - AI based web platform providing print-out of individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder Receives: Other: Gustabor server |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rating of the nutritional intervention as helpful
Rating of the overall nutritional intervention as helpful at the second visit within 12 weeks after inclusion my means of questionnaire. Rating using a 3-point scale: "Tried it and it didn't help", "Was somewhat helpful" and "Was very helpful".
Measured: Within 12 weeks of inclusion
Secondary outcomes (3)
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.
Measured: Within 12 weeks of inclusion
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".
Measured: Within 12 weeks of inclusion
Exploration of correlations between measures and taste perception, tumor type and ongoing tumor therapy
Correlation of the 3-point rated individual measures with individual taste perceptions, tumor type and ongoing tumor therapy
Measured: Within 12 weeks of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start25 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, non-blinded intervention study
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LMU Klinikum, University Hospital Regensburg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040189
- Sponsor's protocol ID
- Gustabor1
- Acronym
- GustaborPilot
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gustabor Phase 1 - AI-based Creation of a Nutritional Plan to Compensate for Chemotherapy-induced Taste Disorders
- ClinicalTrials.gov ID
- NCT07040189
- Acronym / sponsor ID
- GustaborPilot / Gustabor1
- Conditions
- Multiple Myeloma, GI Cancer, Taste Disorders
- Keywords
- taste disorders, AI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- LMU Klinikum, University Hospital Regensburg
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 pilot study aims to use an AI-based, or rule-driven system to generate personalized recommendations based on patients' specific impairments and taste disorder. For the pilot study, the AI will be trained on recipes to create individualized meal plans, helping to identify foods that are likely to be better. The primary endpoint is the assessment of the nutritional intervention as helpful at the second visit within 12 weeks of inclusion.
Detailed description
The primary goal of this pilot study is to evaluate the feasibility and perceived helpfulness of a web application using AI-supported, personalized dietary recommendations for patients experiencing taste disorders during or after cancer therapy. The primary endpoint is the assessment of the nutritional intervention as helpful at the second visit within 12 weeks of inclusion.
The study is a prospective, single-arm, non-blinded intervention study with a maximum duration of 12 weeks for individual participants. Participants will be identified on the ward or in outpatient centers during their clinical treatment routine. Study measures and progress assessments will also only take place during the chemotherapy administrations planned as part of the clinical treatment routine or during the follow-up visits.
Data is entered into the Gustabor portal together with study staff. Initially, anthropometric data, eating habits, taste experiences, and taste alterations are recorded via questionnaires. Taste thresholds for sweet, sour, salty, bitter, and umami are then assessed using taste strips. Based on these inputs, an AI system generates personalized recipe recommendations as well as recommendations for actions (e.g., cold meals recommended in case of metallic taste), which are printed and reviewed with the participant. Additionally, participants receive a flyer containing general dietary advice for oncology patients. At the start of the study and again after a period of at least three and up to twelve weeks (timed to fit clinical routines), the Patient-Generated Subjective Global Assessment (PG-SGA) score will be recorded, evaluating weight, symptoms, dietary intake, and physical activity. At the second visit it will be assessed which recommendations were implemented and how helpful they were perceived overall (primary endpoint) and in detail.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, non-blinded intervention study
| Arm | Type | Receives |
|---|---|---|
| Intervention arm All patients within the study are included in the intervention arm | Experimental | Other: Gustabor serverGustabor server - AI based web platform providing print-out of individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- Suffering from one of the following tumor entities: Multiple myeloma 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
Key exclusion criteria (3 listed)
- Pregnancy
- Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)
- Placement in an inpatient care facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gustabor serverAI based web platform providing individual lifestyle tips and recipe recommendations based on the patient's individual data and taste disorder | Other | Intervention arm All patients within the study are included in the intervention arm |
Primary outcome
Patient rating of the nutritional intervention as helpful
Time frame: Within 12 weeks of inclusion
Rating of the overall nutritional intervention as helpful at the second visit within 12 weeks after inclusion my means of questionnaire. Rating using a 3-point scale: "Tried it and it didn't help", "Was somewhat helpful" and "Was very helpful".
3 secondary outcomes
Patient-generated Subjective Global Assessment (PG-SGA) Score
Time frame: Within 12 weeks of inclusion
Identification of measures that were perceived as helpful
Time frame: Within 12 weeks of inclusion
Exploration of correlations between measures and taste perception, tumor type and ongoing tumor therapy
Time frame: Within 12 weeks of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Fleischer, Dr. med. contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gustabor server in people with Multiple Myeloma and GI Cancer, run by Wuerzburg University Hospital at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Hann, Prof. Dr. med. (+49 931 201 45918, Hann_A@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rating of the nutritional intervention as helpful (time frame: Within 12 weeks of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.