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

NCT ID: NCT00811824

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Immediate physical activity and dietary change intervention

Group Type: ACTIVE_COMPARATOR

Physical activity and dietary change

Intervention Type: BEHAVIORAL

6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class

2

Delayed physical activity and dietary change intervention

Group Type: OTHER

Physical activity and dietary change

Intervention Type: BEHAVIORAL

6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Heather Greenlee

Assistant Professor, Department of Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Greenlee, ND, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25833781 (View on PubMed)

Other Identifiers

AAAB8839

Identifier Type: -

Identifier Source: org_study_id