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

NCT02716623 | Completed

• 2 other identifiers: STUDY00001802UL1TR000001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Presence of Tumor M2-PK

  12 months

Study Arms (1)

CR Diet and Exercise

EXPERIMENTAL

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

Other: CR diet; Behavioral: Exercise

Interventions

CR diet OTHER

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

Also known as: Carbohydrate restricted diet

CR Diet and Exercise

Exercise BEHAVIORAL

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

CR Diet and Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Diabetes Mellitus

Interventions

Diet, Carbohydrate-Restricted; Exercise

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eugene Lee, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

US (2)