Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Study participants will be recruited from the University Of Kansas Cancer Center.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Wulff- Burchfield, MD | The University of Kansas Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| The University of Kansas Cancer Center, Westwood Campus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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. | 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. | 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. | 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. | 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. | 0-14 days prior to initial chemotherapy until (before) day of surgery |
| Kansas City |
| Kansas |
| 66205 |
| United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |