Skip to main content
OpenTrials
Completed

NCT Number: NCT00811824

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in weight

    Time frame: 6 months, 12 months

  2. Intervention adherence

    Time frame: 6 months, 12 months

Secondary outcomes

  1. Barriers to participation

    Time frame: 3 months, 6 months, 9 months, 12 months

  2. Predictors of adherence

    Time frame: 3 months, 6 months, 9 months, 12 months

  3. Changes in anthropometric measures

    Time frame: 3 months, 6 months, 9 months, 12 months

  4. Changes in fitness

    Time frame: 3 months, 6 months, 9 months, 12 months

  5. Changes in hormonal biomarkers

    Time frame: 3 months, 6 months, 9 months, 12 months

  6. Changes in metabolic markers

    Time frame: 3 months, 6 months, 9 months, 12 months

  7. Changes in psychological and quality of life measures

    Time frame: 3 months, 6 months, 9 months, 12 months

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Dec 19, 2008
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.