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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00811824

Run by

Columbia University

People needed

42

Starts

2007-07-01

Expected to finish

2012-11-01

Last updated by the study team

2013-02-22

Who can join

Age: 21 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.