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Investigating the Role of a Lifestyle Intervention on Novel Estrogen Biomarkers

35 Years
65 Years
Not Enrolling
High-risk of Breast Cancer

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Trial Information

Investigating the Role of a Lifestyle Intervention on Novel Estrogen Biomarkers

Inclusion Criteria:

- High-risk of breast cancer according to Breast Cancer Risk Tool (BCRT)based on the
GAIL model

- Women between the ages of 35-65

- BMI between >28 and <40

- Physically able to undertake a moderate to vigorous exercise program

- Ability to attend weekly group counseling sessions and clinic visits

- Agrees to be randomly assigned

- Ability to communicate in English

- Provides informed consent

Exclusion Criteria:

- Previous diagnosis of invasive cancer within the past 10 years (in situ breast cancer
and simple basal or squamous cell carcinoma not included)

- Contraindications for entry into a physical intervention program

- Regularly engaged in more than 90 minutes of moderate to vigorous exercise

- Abuse of alcohol and/or non-prescription drugs

- Planning to leave the geographic area for an extended period of time during the
course of the study

- Transportation issues

- Women who are pregnant or planning on becoming pregnant during the course of the

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Percent adiposity

Outcome Description:

Percent adiposity as measured by a DEXA scan.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Kerryn W Reding, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Human Subjects Division, University of Washington

Study ID:




Start Date:

July 2013

Completion Date:

December 2014

Related Keywords:

  • High-risk of Breast Cancer
  • breast cancer
  • estrogen
  • diet
  • exercise
  • Breast Neoplasms



Fred Hutchinson Cancer Research CenterSeattle, Washington  98109