Clinical trial NCT04567719: Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer
Official title: The Role of Bladder Cancer TAS2R38 Expression on Chemotherapy-Induced Bitter Taste
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bladder Cancer
Keywords: Musle Invasive
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2020-09-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants will be recruited from the University Of Kansas Cancer 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perceived strength of taste for the bitter and sweet tastes
timeFrame: From baseline (0-14 days prior to initial chemotherapy) until day of surgery (prior to participant undergoing surgery)
Secondary outcomes:
measure: Changes in nutrition status
timeFrame: 0-14 days prior to initial chemotherapy until (before) day of surgery
measure: Change in body composition
timeFrame: 0-14 days prior to initial chemotherapy until (before) day of surgery
measure: TAS2R38 expression in tongue and tumor/ tumor- adjacent tissues
timeFrame: 0-14 days prior to initial chemotherapy until (before) day of surgery
measure: Differences between nutrition status at protocol scheduled visits
timeFrame: 0-14 days prior to initial chemotherapy until (before) day of surgery
measure: Difference between body composition at protocol scheduled visits
timeFrame: 0-14 days prior to initial chemotherapy until (before) day of surgery
measure: Difference between TAS2R38 expression at protocol scheduled visits.
timeFrame: 0-14 days prior to initial chemotherapy until (before) day of surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
Study officials:
affiliation: The University of Kansas Cancer Center
name: Elizabeth Wulff- Burchfield, MD
role: PRINCIPAL_INVESTIGATOR
References: