Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bladder Cancer

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66205
      • The University of Kansas Cancer Center, Westwood Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study participants will be recruited from the University Of Kansas Cancer Center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Changes in Taste Perception After Exposure to Chemotherapy; 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?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Elizabeth Wulff- Burchfield, MD, The University of Kansas Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Musle Invasive
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: IIT-2019-BitterTaste

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No