Breast Cancer
Conditions
Keywords
Weight loss, Physical activity, Dietary change
Brief 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.
Interventions
BEHAVIORALPhysical activity and dietary change
6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight | 6 months, 12 months |
| Intervention adherence | 6 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in anthropometric measures | 3 months, 6 months, 9 months, 12 months |
| Changes in fitness | 3 months, 6 months, 9 months, 12 months |
| Barriers to participation | 3 months, 6 months, 9 months, 12 months |
| Changes in metabolic markers | 3 months, 6 months, 9 months, 12 months |
| Changes in psychological and quality of life measures | 3 months, 6 months, 9 months, 12 months |
| Changes in hormonal biomarkers | 3 months, 6 months, 9 months, 12 months |
| Predictors of adherence | 3 months, 6 months, 9 months, 12 months |
Countries
United States
Outcome results
None listed