Weight Gain Prevention for Breast Cancer Survivors

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer

In brief

The specific aims of this study are: 1. To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Feasibility will be evaluated by examining data on recruitment rate, attendance at intervention sessions, drop-out rates in both study conditions, assessment completion rates, and participant feedback. 2. To test the effect of a weight gain prevention program, compared to usual care, on weight, body composition, and biomarkers related to breast cancer prognosis. 3. To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors. 4. To test the effect of a weight gain prevention program on quality of life variables.

Key facts

Study ID

NCT00533338

Run by

M.D. Anderson Cancer Center

People needed

46

Starts

2007-07-20

Expected to finish

2020-07-31

Last updated by the study team

2020-01-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Woman with newly diagnosed stage II or III breast cancer.
• Over 18 years of age.
• Beginning neo-adjuvant chemotherapy at M. D. Anderson (no more than 3 weeks from the administration of the first cycle).
• Speaks and reads English.
• Oriented to person, place, and time.
• Able to come to M. D. Anderson once a week for intervention.
• Has physician clearance to engage in moderate physical activity.
• Lives in Harris County, Texas or a county contiguous to Harris County, Texas.

You may not qualify if…

• Have any of the following conditions defined by the American College of Sports Medicine as absolute contraindications to exercise testing (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection).
• Have any of the following conditions as defined by the American College of Sports Medicine as relative contraindications to exercise testing (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease).
• Right or left bundle branch block.
• Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
• Uncontrolled asthma.
• Have other medical contraindications as defined by the patient's physician.
• Have inflammatory breast cancer.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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