Bladder Cancer, Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERCR diet
Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.
BEHAVIORALExercise
Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.
Sponsors
National Institutes of Health (NIH)
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant compliance with study specific CR diet | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Tumor M2-PK | 12 months | Level of Tumor M2-PK will be assessed over the course the study. |
Countries
United States
Outcome results
None listed