Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

Study Overview
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Brief Summary
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Alteration in the sense of taste is a frequent symptom that is closely linked to chemotherapy exposure, lowering quality of life and nutritional status. Malnutrition is of particular concern in muscle-invasive bladder cancer (MIBC), as malnutrition is associated with many negative outcomes from radical cystectomy (the surgical procedure in MIBC), which include higher morbidity, poor wound healing, and higher rate of infections after surgery. It is essential to understand taste changes among participants receiving chemotherapy for MIBC to create future treatment trials.

Official Title
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The Role of Bladder Cancer TAS2R38 Expression on Chemotherapy-Induced Bitter Taste

Conditions
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Bladder Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent. Age ≥ 18 years. Histologically proven MIBC (Muscle Invasive Bladder Cancer) without metastatic disease Diagnosis. Planning to undergo neoadjuvant chemotherapy and radical cystectomy for MIBC Exclusion Criteria: No prior systemic chemotherapy for MIBC. Cannot be simultaneously enrolled in any therapeutic clinical trial, unless receiving standard neoadjuvant chemotherapy on said clinical trial. Any oral or cognitive pathology impairing the ability to perform taste testing procedures. No other known malignancy within previous 2 years with the following EXCEPTIONS: Low-grade prostate cancer on active surveillance, CLL on surveillance / observation, non-melanoma skin cancers. No psychiatric illness/social situations that would limit compliance with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Changes in Taste Perception After Exposure to Chemotherapy<br>A total of 20 participants with histologically-proven MIBC planning to receive pre-surgery chemotherapy followed by radical cystectomy will be recruited. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived strength of taste for the bitter and sweet tastes | Taste solution testing using Spectrum(TM) Descriptive Analysis Method. Taste perception is measured on an ordinal scale (e.g. Moderate, Strong, Very Strong). | From baseline (0-14 days prior to initial chemotherapy) until day of surgery (prior to participant undergoing surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutrition status | Patient-Generated Subjective Global Assessment (PG-SGA).The PG-SGA Short Form consist of four questions for the participant to rate their weight, food intake, any symptoms they are experiencing and their activity level, with each answer having a numerical correspondence. That score will be combined with the providers health assessment of weight loss, other health conditions that could affect nutrition, any present symptoms and physical exam; again each evaluation will be given a numeric value. The combined scores will determine the participants level of health; with A being well nourished, B being moderate/ suspected malnourished and C being severely malnourished. | 0-14 days prior to initial chemotherapy until (before) day of surgery | 
| Change in body composition | The Bodystat Quadscan 4000® will measure body fat, lean muscle mass and hydration by placing electrodes on the participants hands and feet. This will show either a resistance or reactance of the electrical flow to determine change in body composition, if any. | 0-14 days prior to initial chemotherapy until (before) day of surgery | 
| TAS2R38 expression in tongue and tumor/ tumor- adjacent tissues | Tongue scraping and tumor tissue will be collected and tested for TAS2R38 in the DNA, RNA and protein. | 0-14 days prior to initial chemotherapy until (before) day of surgery | 
| Differences between nutrition status at protocol scheduled visits | Wilcox signed- rank test will compare each score to determine the changes. The scores will be calculated as either positive or negative numbers. If the total score is positive this will indicate that these measurements are related to taste perception. A negative score will show they are not. | 0-14 days prior to initial chemotherapy until (before) day of surgery | 
| Difference between body composition at protocol scheduled visits | Wilcox signed- rank test will compare each score to determine the changes. The scores will be calculated as either positive or negative numbers. If the total score is positive this will indicate that these measurements are related to taste perception. A negative score will show they are not. | 0-14 days prior to initial chemotherapy until (before) day of surgery | 
| Difference between TAS2R38 expression at protocol scheduled visits. | Wilcox signed- rank test will compare each score to determine the changes. The scores will be calculated as either positive or negative numbers. If the total score is positive this will indicate that these measurements are related to taste perception. A negative score will show they are not. | 0-14 days prior to initial chemotherapy until (before) day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musle Invasive