GustaborRCTRecruiting

Nutrition Recommendations Supported by Artificial Intelligence for Taste Disorders During Cancer Treatment

Gender
Women and men
Age
18 years and older
Trial type
Interventional
Line of therapy
all
Phase

What is this trial about?

Many cancer treatments can alter the sense of taste, which can make it difficult to eat and may lead to malnutrition or discontinuation of treatment. The goal of the Gustabor study is to investigate the impact of personalized dietary recommendations—developed with the support of artificial intelligence—on nutritional status, compared to the general recommendations currently in use. Patients aged 18 and older with multiple myeloma, melanoma, cancer of the urogenital tract, or a malignant tumor of the gastrointestinal tract who notice a taste disturbance caused by cancer treatment are eligible to participate in this study.

Detailed description

Taste disturbances can often occur during or after cancer treatment, leading patients to eat less and have a less varied diet. This can lead to malnutrition or the discontinuation of cancer treatment. Cancer treatments such as chemotherapy or radiation therapy can impair the sense of taste because the taste buds on the tongue are constantly renewing themselves, and treatment can damage these rapidly dividing cells. Changes in saliva and the oral mucosa can also contribute to treatment-related taste disturbances, causing foods and beverages to be perceived differently than usual. A metallic taste is one of the taste changes frequently reported by patients undergoing chemotherapy. To date, taste disorders have primarily been treated without medication, through general dietary and behavioral recommendations.

The aim of this study is to compare how individually tailored dietary recommendations affect nutritional status compared to the currently standard general recommendations. The recommendations are adapted to each patient’s altered taste perception; for example, by increasing the intake of cold foods when a metallic taste is present. To this end, patients are randomly assigned to two treatment groups. For all patients, the change in taste is first assessed using taste strips—a test method commonly used in medicine to evaluate the sense of taste—and questionnaires. In the study arm, based on this assessment, an internet platform that uses artificial intelligence compiles general and targeted dietary recommendations, everyday tips, and recipe suggestions tailored to the patient’s specific taste change and personal preferences. The control arm receives the currently standard, scientifically published recommendations for taste disorders in the form of a printed flyer. The study is open-label, meaning that both the patients and the study physicians know which recommendations are being given. The main objective (primary endpoint) of the study is nutritional status within 12 weeks of enrollment in the study.

Eligible participants include women and men aged 18 and older with multiple myeloma, melanoma, cancer of the urogenital tract, or a malignant tumor of the gastrointestinal tract, who notice taste disturbances caused by their cancer treatment and who primarily eat a normal diet.

Facts

  1. Which conditions: multiple myeloma, melanoma (malignant melanoma of the skin), cancers of the urogenital tract, and malignant tumors of the gastrointestinal tract
  2. Cancer characteristics: ongoing cancer treatment with self-reported, treatment-related taste disturbance (dysgeusia), primarily oral nutrition (via the mouth)
  3. What the study examines: individually tailored dietary recommendations, everyday tips, and recipe suggestions generated by an AI-powered online platform, compared to the currently standard general recommendations provided in the form of a printed flyer
  4. Study objective: To compare how the two forms of nutritional recommendations affect nutritional status within 12 weeks of enrollment in the study
  5. Study duration: approximately 12 weeks per patient starting from enrollment in the study, with at least two study visits spaced at least three weeks apart
  6. Study characteristics: Supportive care study (study on supportive treatment), two treatment groups, randomly assigned, open-label (unblinded)

Trial sites

6 trial sites in Germany are listed.

  • Universitätsklinikum Augsburg

    86156 Augsburg

    In preparation
  • Universitätsklinikum Erlangen

    91054 Erlangen

    Recruiting
  • Klinikum rechts der Isar der Technischen Universität München

    81675 München

    In preparation
  • LMU Klinikum Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center

    81377 München

    Recruiting
  • Universitätsklinikum Regensburg

    93053 Regensburg

    In preparation
  • Universitätsklinikum Würzburg

    97080 Würzburg

    In preparation

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT07649681) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.