The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer (DEAL)
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Study type
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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