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Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Phase 2
21 Years
70 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Inclusion Criteria:

- 21-70 yrs

- Stage 0-IIIa breast cancer

- No evidence of recurrent/metastatic disease

- Hispanic or African descent (African-American or Caribbean)

- BMI > 25kg/m2

- Sedentary

- Completed surgery, chemotherapy, and radiation therapy ≥ 6 months

- Blood pressure < 140/90

- HgbA1C < 8

- LDL cholesterol < 150

- No uncontrolled comorbidities

- VO2 max normal EKG changes

- Non-smoker

Exclusion Criteria:

- Evidence of recurrent or metastatic breast cancer

- Uncontrolled co-morbid illness including, but not limited to, type I diabetes
mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart
failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary
disease; hypercholesterolemia, neurological condition, ischemic heart disease,
cardiac disease, kidney disease, respiration problems, asthma, shortness of breath,
physical limitations, abnormal thyroid function, active malignancy, except for
squamous or basal cell carcinoma of the skin; receiving active chemotherapy or
radiotherapy; or psychiatric illness/social situations that would limit compliance
with study requirements

- Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy

- Active tobacco use

- Currently active in an exercise and/or dietary change weight loss program

- If a participant develops a breast cancer recurrence or metastasis during the
12-month study period, her participation in the study will be terminated.

Type of Study:


Study Design:

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

Outcome Measure:

Change in weight

Outcome Time Frame:

6 months, 12 months

Safety Issue:


Principal Investigator

Heather Greenlee, ND, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • Weight loss
  • Physical activity
  • Dietary change
  • Breast Neoplasms



Columbia UniversityNew York, New York  10032-3784