Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

Active, not recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT04567719
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-03
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Differences between nutrition status at protocol scheduled visits	0-14 days prior to initial chemotherapy until (before) day of surgery	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.
Change in body composition	0-14 days prior to initial chemotherapy until (before) day of surgery	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.
Difference between TAS2R38 expression at protocol scheduled visits.	0-14 days prior to initial chemotherapy until (before) day of surgery	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.
Changes in nutrition status	0-14 days prior to initial chemotherapy until (before) day of surgery	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.
TAS2R38 expression in tongue and tumor/ tumor- adjacent tissues	0-14 days prior to initial chemotherapy until (before) day of surgery	Tongue scraping and tumor tissue will be collected and tested for TAS2R38 in the DNA, RNA and protein.
Difference between body composition at protocol scheduled visits	0-14 days prior to initial chemotherapy until (before) day of surgery	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.

Trial Locations

Locations (2)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

The University of Kansas Cancer Center, Westwood Campus; 🇺🇸 Kansas City, Kansas, United States