Status:
TERMINATED
Lifestyle Change for Better Health
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Telomere Shortening
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief Summary
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in...
Eligibility Criteria
Inclusion
- BMI between 25.0 to \<40 kg/m2 (allows for use of assessments such as DXA to be included)
- History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma
- Under clinical surveillance with no evidence of disease
Exclusion
- WHO performance status 3-4 or deemed physically unable to participate by physician
- Currently pregnant or breastfeeding, were pregnant in the previous 6 months or breastfeeding in the previous 3 months, or planning pregnancy in the next year
- History of bariatric surgery
- Medical condition that could affect body weight (e.g., diabetes mellitus, hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic liver disease, gastrointestinal disorders including ulcerative colitis)
- Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years
- Current congestive heart failure, signs or symptoms indicative of an increased acute risk for a cardiovascular event
- History of myocardial infarction, coronary artery bypass or angioplasty, conditions requiring chronic anticoagulation (recent or recurrent DVT)
- Resting systolic blood pressure of \>160 mmHg or diastolic blood pressure \>100 mmHg
- Eating disorder that would contraindicate weight loss or physical activity
- Alcohol or substance abuse
- Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or taking daily or extended release psychotropic medications in the previous 12 months
- Report exercising more than 100 minutes per week over the past 3 months (NOTE: includes physical activity performed for sport, fitness, or recreational activity; physical activity performed as part of occupation or household chores is not included)
- Weight loss of greater than 5% or participating in a weight reduction diet in the past 3 months
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03286699
Start Date
June 1 2017
End Date
October 1 2024
Last Update
January 10 2025
Active Locations (1)
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1
UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232