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

Not Applicable

Completed

• Conditions: Bladder Cancer; Diabetes Mellitus
• Interventions: Other: CR diet; Behavioral: Exercise

• Registration Number: NCT02716623
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CR Diet and Exercise	CR diet	Participants will be asked to follow specific diet intervention and exercise regimen.
CR Diet and Exercise	Exercise	Participants will be asked to follow specific diet intervention and exercise regimen.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Presence of Tumor M2-PK	12 months	Level of Tumor M2-PK will be assessed over the course the study.

Trial Locations

Locations (2)

University of Kansas Cancer Center; 🇺🇸 Kansas City, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States