Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

NCT04567719 | Active Not Recruiting DMC

• 1 other identifier: IIT-2019-BitterTaste
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer

Keywords

Musle Invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in nutrition status

  0-14 days prior to initial chemotherapy until (before) day of surgery

• Change in body composition

  0-14 days prior to initial chemotherapy until (before) day of surgery

• TAS2R38 expression in tongue and tumor/ tumor- adjacent tissues

  0-14 days prior to initial chemotherapy until (before) day of surgery

• Differences between nutrition status at protocol scheduled visits

  0-14 days prior to initial chemotherapy until (before) day of surgery

• Difference between body composition at protocol scheduled visits

  0-14 days prior to initial chemotherapy until (before) day of surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (2)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tongue scrapings will be used for the measurement of TAS2R38 receptor expression by DNA, RNA, and protein. Samples from the participant's existing bladder biopsy specimen and radical cystectomy specimen will be obtained and TAS2R38 receptor expression will be measured by DNA, RNA, and protein.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Elizabeth Wulff- Burchfield, MD

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: March 3, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)