SUPPORT HOTLINE (888) 901-2226
Donate Now

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

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


  • Org Study ID: STUDY00001802
  • Secondary ID: UL1TR000001
  • NCT ID: NCT02716623
  • NCT Alias:
  • Sponsor: University of Kansas Medical Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: March 2016 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Participant compliance with study specific CR diet

Primary Outcome 1 - Time Frame: 12 months

Condition:

  • Bladder Cancer
  • Diabetes Mellitus

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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Eugene Lee, MD

Role: Principal Investigator

Affiliation: University of Kansas Medical Center

Overall Contact

Name: Eugene Lee, MD

Phone: 913-588-7564

Email: elee@kumc.edu

Locations

Facility Status Contact
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Recruiting