Bladder CancerNCT04567719
Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from the University Of Kansas Cancer Center.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Kansas Medical Center
Kansas City, Kansas, 66160
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
About this study
Official title: 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.
- Conditions
- Bladder Cancer
- Keywords
- Musle Invasive
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-14 days prior to initial chemotherapy until (before) day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start3 Mar 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Wulff- Burchfield, MD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567719
- Sponsor's protocol ID
- IIT-2019-BitterTaste
- Status last verified
- Feb 2024
- First submitted
- 23 Sep 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bladder Cancer TAS2R38 Expression on Chemotherapy-Induced Bitter Taste
- ClinicalTrials.gov ID
- NCT04567719
- Acronym / sponsor ID
- IIT-2019-BitterTaste
- Conditions
- Bladder Cancer
- Keywords
- Musle Invasive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from the University Of Kansas Cancer Center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived strength of taste for the bitter and sweet tastes
Time frame: From baseline (0-14 days prior to initial chemotherapy) until day of surgery (prior to participant undergoing surgery)
Taste solution testing using Spectrum(TM) Descriptive Analysis Method. Taste perception is measured on an ordinal scale (e.g. Moderate, Strong, Very Strong).
6 secondary outcomes
Changes in nutrition status
Time frame: 0-14 days prior to initial chemotherapy until (before) day of surgery
Change in body composition
Time frame: 0-14 days prior to initial chemotherapy until (before) day of surgery
TAS2R38 expression in tongue and tumor/ tumor- adjacent tissues
Time frame: 0-14 days prior to initial chemotherapy until (before) day of surgery
Differences between nutrition status at protocol scheduled visits
Time frame: 0-14 days prior to initial chemotherapy until (before) day of surgery
Difference between body composition at protocol scheduled visits
Time frame: 0-14 days prior to initial chemotherapy until (before) day of surgery
Difference between TAS2R38 expression at protocol scheduled visits.
Time frame: 0-14 days prior to initial chemotherapy until (before) day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Wulff- Burchfield, MD principal investigator
The University of Kansas Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived strength of taste for the bitter and sweet tastes (time frame: From baseline (0-14 days prior to initial chemotherapy) until day of surgery (prior to participant undergoing surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.