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

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ClinicalTrials.gov Identifier: NCT02716623
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eugene Lee, MD, 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Diabetes Mellitus Other: CR diet Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
Study Start Date : March 2016
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CR Diet and Exercise
Participants will be asked to follow specific diet intervention and exercise regimen.
Other: CR diet
Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.
Other Name: Carbohydrate restricted diet

Behavioral: Exercise
Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.




Primary Outcome Measures :
  1. Participant compliance with study specific CR diet [ Time Frame: 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 :
  1. Presence of Tumor M2-PK [ Time Frame: 12 months ]
    Level of Tumor M2-PK will be assessed over the course the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716623


Locations
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United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Eugene Lee, MD University of Kansas Medical Center
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Responsible Party: Eugene Lee, MD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02716623    
Other Study ID Numbers: STUDY00001802
UL1TR000001 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases