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

NCT ID: NCT02716623

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-05-01

Brief Summary

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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

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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.

Conditions

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Bladder Cancer Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CR Diet and Exercise

Participants will be asked to follow specific diet intervention and exercise regimen.

Group Type EXPERIMENTAL

CR diet

Intervention Type OTHER

Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.

Exercise

Intervention Type BEHAVIORAL

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

Interventions

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CR diet

Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.

Intervention Type OTHER

Exercise

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Carbohydrate restricted diet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eugene Lee, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugene Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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UL1TR000001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001802

Identifier Type: -

Identifier Source: org_study_id

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