Multiple Myeloma (MM)GustaborRCTNCT07649681
Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention
A study testing Gustabor server and Standard Recommendations in people with Multiple Myeloma (MM) and GI Cancer, run by Wuerzburg University Hospital at 6 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 (MM), GI Cancer, Taste Disorder
- What is being tested?
- Gustabor server and Standard Recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 6 sitesGermany
- Study dates
- 24 Jul 2026to 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, 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).
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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. med. Anna Fleischer contact
6 sites in 1 country
Germany6 sites, 6 recruiting
- Not yet recruiting
Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
- Recruiting
LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center
München, Bavaria, 81377
- Not yet recruiting
Klinikum der Technischen Universität München (TUM Klinikum)
München, Bavaria, 81675
- Not yet recruiting
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053
- Not yet recruiting
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Prof. Dr. med. Alexander Hann, +49 931 201 45918, Hann_A@ukw.de
Dr. med. Anna Fleischer, 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 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.
- Conditions
- Multiple Myeloma (MM), GI Cancer, Taste Disorder, Melanoma (Skin Cancer), Urogenital Cancers
- Being tested
- Gustabor server, Standard Recommendations
- Medical subject headings
- Multiple Myeloma, Gastrointestinal Neoplasms, Taste Disorders, Melanoma, Urogenital Neoplasms
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
Standard RecommendationsOther
Flyer consisting of current standard recommendations for taste disorders from scientifically published measures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Gustabor server |
| Control Group | Other | Receives the current standard recommendations for taste disorders from scientifically published measures in form of a printed-out flyer. Receives: Other: Standard Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (2)
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
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.
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 posted16 Jun 2026
- Study start24 Jul 2026
- 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 Myeloma (MM)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, non-blinded intervention study
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LMU Klinikum, University Hospital Regensburg, University Hospital Erlangen, University Hospital Augsburg, TUM Klinikum
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649681
- Sponsor's protocol ID
- Gustabor2
- Acronym
- GustaborRCT
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention
- ClinicalTrials.gov ID
- NCT07649681
- Acronym / sponsor ID
- GustaborRCT / Gustabor2
- Conditions
- Multiple Myeloma (MM), GI Cancer, Taste Disorder, Melanoma (Skin Cancer), Urogenital Cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- LMU Klinikum, University Hospital Regensburg, University Hospital Erlangen, University Hospital Augsburg, TUM Klinikum
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jun 2026 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, non-blinded intervention study
| Arm | Type | Receives |
|---|---|---|
| Gustabor Group | Experimental | Other: Gustabor serverGustabor 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 | Other: Standard RecommendationsReceives the current standard recommendations for taste disorders from scientifically published measures in form of a printed-out flyer. |
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, 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
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 | Gustabor Group |
| Standard RecommendationsFlyer consisting of current standard recommendations for taste disorders from scientifically published measures | Other | Control Group |
Primary outcome
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.
2 secondary outcomes
Identification of measures that were perceived as helpful
Time frame: 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)
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Dr. med. Anna Fleischer contact
6 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 and Standard Recommendations in people with Multiple Myeloma (MM) and GI Cancer, run by Wuerzburg University Hospital at 6 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 20 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 6 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 Prof. Dr. med. Alexander Hann (+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-generated Subjective Global Assessment (PG-SGA) Score (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 20 Aug 2026.