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

NCT00811824 | Completed Phase 2

• 1 other identifier: AAAB8839
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Weight loss; Physical activity; Dietary change

Outcome Measures

Primary Outcomes (2)

• Change in weight

  6 months, 12 months

• Intervention adherence

  6 months, 12 months

Secondary Outcomes (7)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Immediate physical activity and dietary change intervention

Behavioral: Physical activity and dietary change

2

OTHER

Delayed physical activity and dietary change intervention

Behavioral: Physical activity and dietary change

Interventions

Physical activity and dietary change BEHAVIORAL

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

1; 2

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 25833781 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Heather Greenlee, ND, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Epidemiology

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: July 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2012
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

US (1)