The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Participant compliance with study specific CR diet
研究概览
简要总结
The purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.
详细描述
This study will examine the effects of a carbohydrate restricted (CR) diet in bladder cancer patients with diabetes. The goal of this pilot study is to determine if the CR diet and exercise routine are feasible for this patient population to follow.
Participants in this study will receive meals tailored to their specific needs. A registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study.
Participants will be asked to be in this study for up to 12 months. A participant will be asked to make a total of 16 in-person visits over the course of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Diagnosis of non-muscle-invasive bladder cancer
- •Have completed Transurethral Resection of Bladder Tumor (TURBT) procedure
- •Diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening
排除标准
- •Evidence of muscle-invasion or metastatic disease
- •BMI less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (PGSGA)
- •Unable to complete the exercise regimen or deemed a fall risk
- •Participating in a research study involving any form of treatment intervention
研究组 & 干预措施
CR Diet and Exercise
Participants will be asked to follow specific diet intervention and exercise regimen.
干预措施: CR diet (Other)
CR Diet and Exercise
Participants will be asked to follow specific diet intervention and exercise regimen.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Participant compliance with study specific CR diet
时间窗: 12 months
Measure participant compliance with CR diet. Compliance will be measured through adherence to study diet. Study team members will regularly check in with participants to track weekly food data.
次要结局
- Presence of Tumor M2-PK(12 months)
研究者
Eugene Lee, MD
Assistant Professor
University of Kansas Medical Center