Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

NCT ID: NCT04567719

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-03

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Wulff- Burchfield, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Kansas Cancer Center

Locations

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The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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IIT-2019-BitterTaste

Identifier Type: -

Identifier Source: org_study_id

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