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

NCT00811824•Columbia University

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.

Eligibility

Age

21 - 70 years

Sex

FEMALE

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
+3 more criteria

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.

Locations (1)

Columbia University

New York, New York, United States

Key Dates

Start Date

July 1, 2007

Primary Completion Date

September 1, 2009

Completion Date

November 1, 2012

Last Updated

February 22, 2013

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Physical activity and dietary change

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 22, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer