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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Physical activity and dietary change

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Immediate physical activity and dietary change intervention	Behavioral: Physical 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
Other: 2; Delayed physical activity and dietary change intervention	Behavioral: Physical 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weight	6 months, 12 months
Intervention adherence	6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Barriers to participation	3 months, 6 months, 9 months, 12 months
Predictors of adherence	3 months, 6 months, 9 months, 12 months
Changes in anthropometric measures	3 months, 6 months, 9 months, 12 months
Changes in fitness	3 months, 6 months, 9 months, 12 months
Changes in hormonal biomarkers	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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Heather Greenlee, ND, PhD, Columbia University

Publications and helpful links

General Publications

• Delgado-Cruzata L, Zhang W, McDonald JA, Tsai WY, Valdovinos C, Falci L, Wang Q, Crew KD, Santella RM, Hershman DL, Greenlee H. Dietary modifications, weight loss, and changes in metabolic markers affect global DNA methylation in Hispanic, African American, and Afro-Caribbean breast cancer survivors. J Nutr. 2015 Apr;145(4):783-90. doi: 10.3945/jn.114.202853. Epub 2015 Feb 4.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 18, 2008
• First Submitted That Met QC Criteria: December 18, 2008
• First Posted (Estimate): December 19, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Weight loss; Physical activity; Dietary change
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AAAB8839