Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04567719
• Other study ID #: IIT-2019-BitterTaste
• Status: Active, not recruiting
• Start date: March 3, 2020
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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