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Brief Title: Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

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

INTRODUCTION

  • Org Study ID: IIT-2019-BitterTaste
  • Secondary ID: N/A
  • NTC ID: NCT04567719
  • 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.

  • Overall Status
    Recruiting
  • Start Date
    March 3, 2020
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Perceived strength of taste for the bitter and sweet tastes

Primary Outcome 1 - Timeframe: From baseline (0-14 days prior to initial chemotherapy) until day of surgery (prior to participant undergoing surgery)

CONDITION

  • Bladder Cancer

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Elizabeth Wulff- Burchfield, MD

Role: Principal Investigator

Affiliation: The University of Kansas Cancer Center

Overall Contact

Name: Elizabeth Wulff- Burchfield, MD

Phone: 913-588-3671

Email: Navigation@kumc.edu

LOCATION

Facility Status Contact
Facility: The University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: Contact
Clinical Trials Nurse Navigator
913-945-7552
ctnursenav@kumc.edu
Facility: The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas 66205
United States
Status: Recruiting Contact: N/A