The Role of Bladder Cancer TAS2R38 Expression on Chemotherapy-Induced Bitter Taste
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Perceived strength of taste for the bitter and sweet tastes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Perceived strength of taste for the bitter and sweet tastes
时间窗: 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).
次要结局
- Differences between nutrition status at protocol scheduled visits(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)
- Difference between TAS2R38 expression at protocol scheduled visits.(0-14 days prior to initial chemotherapy until (before) day of surgery)
- Changes in nutrition status(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)
- Difference between body composition at protocol scheduled visits(0-14 days prior to initial chemotherapy until (before) day of surgery)