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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811824
• Other study ID #: AAAB8839
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2008
• Last updated: February 21, 2013
• Start date: July 2007
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2012
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight		6 months, 12 months	No
Primary	Intervention adherence		6 months, 12 months	No
Secondary	Barriers to participation		3 months, 6 months, 9 months, 12 months	No
Secondary	Predictors of adherence		3 months, 6 months, 9 months, 12 months	No
Secondary	Changes in anthropometric measures		3 months, 6 months, 9 months, 12 months	No
Secondary	Changes in fitness		3 months, 6 months, 9 months, 12 months	No
Secondary	Changes in hormonal biomarkers		3 months, 6 months, 9 months, 12 months	No
Secondary	Changes in metabolic markers		3 months, 6 months, 9 months, 12 months	No
Secondary	Changes in psychological and quality of life measures		3 months, 6 months, 9 months, 12 months	No