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