The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer

Study Overview
=================
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.

Official Title
-----------------
The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: CR diet
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CR Diet and Exercise<br>Participants will be asked to follow specific diet intervention and exercise regimen. | Other: CR diet<br>* Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.<br>* Other names: Carbohydrate restricted diet;Behavioral: Exercise<br>* Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant compliance with study specific CR diet | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Tumor M2-PK | Level of Tumor M2-PK will be assessed over the course the study. | 12 months |