Back to resultsThe Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer (DEAL)
Primary Purpose
Bladder Cancer, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CR diet
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Bladder Cancer
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
Sites / Locations
- University of Kansas Cancer Center
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CR Diet and Exercise
Arm Description
Participants will be asked to follow specific diet intervention and exercise regimen.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Presence of Tumor M2-PK
Level of Tumor M2-PK will be assessed over the course the study.
Full Information
NCT ID
NCT02716623
First Posted
March 10, 2016
Last Updated
July 11, 2019
Sponsor
University of Kansas Medical Center
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02716623
Brief Title
The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
Acronym
DEAL
Official Title
The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Diabetes Mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CR Diet and Exercise
Arm Type
Experimental
Arm Description
Participants will be asked to follow specific diet intervention and exercise regimen.
Intervention Type
Other
Intervention Name(s)
CR diet
Other Intervention Name(s)
Carbohydrate restricted diet
Intervention Description
Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.
Primary Outcome Measure Information:
Title
Participant compliance with study specific CR diet
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Presence of Tumor M2-PK
Description
Level of Tumor M2-PK will be assessed over the course the study.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Lee, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
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