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

Columbia University

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Behavioral: Physical activity and dietary change

Study type

Interventional

Funder types

Other

Identifiers

NCT00811824

AAAB8839

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

Female

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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.