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BRIEF TITLE: Leukocyte Telomere Length in Bladder Cancer Survivors: Diet and Exercise Trial

Leukocyte Telomere Length in Bladder Cancer Survivors: Diet and Exercise Trial


  • Org Study ID: CA212628
  • Secondary ID: R21CA212628
  • NCT ID: NCT03286699
  • NCT Alias:
  • Sponsor: University of Pittsburgh - Other
  • Source: University of Pittsburgh

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 individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.

Overal Status Start Date Phase Study Type
Recruiting June 1, 2017 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)

Primary Outcome 1 - Time Frame: Blood samples will be collected as part of the 6 month assessment

Condition:

  • Bladder Cancer
  • Telomere Shortening
  • Colorectal Adenoma

Eligibility

Criteria:
Inclusion Criteria:

- 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 Criteria:

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: 84 Years

Healthy Volunteers: No

Official Information

Name: Dana Bovbjerg, PhD

Role: Principal Investigator

Affiliation: University of Pittsburgh

Overall Contact

Name: Jessica Manculich

Phone: 412-623-8942

Email: mancjf@upmc.edu

Location

Facility Status Contact
UPMC Shadyside
Pittsburgh, Pennsylvania 15232
United States
Recruiting Jessica Manculich
412-623-8942
mancjf@upmc.edu