Breast Cancer Clinical Trial

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

Summary

This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT00811824

Recruitment Status:

Completed

Sponsor:

Columbia University

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There is 1 Location for this study

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Columbia University
New York New York, 10032, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT00811824

Recruitment Status:

Completed

Sponsor:


Columbia University

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