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Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470119
  Purpose

RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.

PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.


Condition Intervention
Breast Cancer
Obesity
Weight Changes
Procedure: behavioral dietary intervention
Procedure: complementary or alternative medicine procedure
Procedure: dietary intervention
Procedure: educational intervention
Procedure: evaluation of cancer risk factors
Procedure: exercise intervention
Procedure: immunoscintigraphy
Procedure: laboratory biomarker analysis
Procedure: mammography
Procedure: preventative dietary intervention
Procedure: quality-of-life assessment

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Exercise and Physical Fitness    Mammography    Obesity   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized
Official Title:   Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Serum estrone concentrations as measured by radioimmunoassay at 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum estradiol and free estradiol concentration as measured by radioimmunoassay at 12 months [ Designated as safety issue: No ]
  • Testosterone and free testosterone as measured at 12 months [ Designated as safety issue: No ]
  • Sex hormone binding globulin as measured at 12 months [ Designated as safety issue: No ]
  • Insulin and insulin-like growth factor (IGF)-1 as measured at 12 months [ Designated as safety issue: No ]
  • IGF binding protein-3 as measured at 12 months [ Designated as safety issue: No ]
  • Mammographic density (i.e., percentage density and dense area) as measured at 12 months [ Designated as safety issue: No ]
  • Weight and body mass index as measured at 12 months [ Designated as safety issue: No ]
  • Total and percentage body fat and body fat distribution (i.e., waist and hip circumferences) as measured by dual x-ray absorptiometry at 12 months [ Designated as safety issue: No ]
  • Quality of life as measured at baseline, 6 months, and 12 months [ Designated as safety issue: No ]
  • Change in daily caloric intake as measured by Food Frequency Questionnaire at baseline, 6 months, and 12 months [ Designated as safety issue: No ]

Estimated Enrollment:   503
Study Start Date:   December 2004
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • At increased risk for developing breast cancer due to any of the following lifestyle risk factors:

    • Lack of physical activity
    • Excess weight
    • Obesity
    • Weight gain over lifetime
  • Body mass index > 25.0
  • Physically able to undertake a moderate exercise or calorie reduction program
  • No history of invasive or in situ breast cancer

PATIENT CHARACTERISTICS:

  • Postmenopausal, defined by the absence of periods for the past 12 months
  • Able to attend study clinic visits and classes, and undergo study measurements
  • Able to fill out questionnaires and logs in English
  • No moderate to high alcohol intake (more than 2 drinks per day)
  • No concurrent smoking
  • No invasive cancer within the past 10 years except simple basal cell or squamous cell carcinoma
  • No diabetes mellitus

    • Fasting blood sugar < 126 mg/dL (on 2 occasions)
  • Hematocrit 32-48%
  • WBC 3,000-15,000/mm³
  • Potassium 3.5-5.0 mEq/L
  • Creatinine ≤ 2.0 mg/dL
  • No abnormalities on screening physical that contraindicate study participation
  • No contraindications for treadmill testing or entry into a training program, including any of the following:

    • Myocardial infarction within the past 6 months
    • Pulmonary edema
    • Myocarditis
    • Pericarditis
    • Unstable angina
    • Pulmonary embolism or deep vein thrombosis
    • Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
    • Orthostatic hypotension
    • Moderate-to-severe aortic stenosis
    • Uncontrolled arrhythmia
    • Uncontrolled congestive heart failure
    • Third-degree heart block
    • Left bundle branch block
    • Thrombophlebitis
    • ST depression > 3 mm at rest
    • History of cardiac arrest or stroke
  • Normal exercise treadmill testing (ETT)

    • Negative thallium or echo ETT required for patients with abnormal ETT (defined as ≥ 1.5 mm ST depression in > 1 lead within 1-minute recovery OR ≥ 1.1 mm ST depression in > 1 lead after 1-minute recovery OR reading of positive test by study doctor)
  • No drug abuse
  • No significant mental illness

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior and no concurrent menopausal hormone replacement therapy of any type, including vaginal route
  • No concurrent participation in any other organized weight loss or exercise program
  • No concurrent appetite suppressant medication
  • No concurrent medications (e.g., weight-loss medications) likely to interfere with adherence to interventions or study outcomes
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470119

Locations
United States, Washington
Fred Hutchinson Cancer Research Center     Recruiting
      Seattle, Washington, United States, 98109-1024
      Contact: Anne McTiernan, MD     206-667-7979        

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Anne McTiernan, MD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000544634, FHCRC-PHS-1960.00, FHCRC-1960
First Received:   May 3, 2007
Last Updated:   July 25, 2008
ClinicalTrials.gov Identifier:   NCT00470119
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer  
obesity  
weight changes  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Skin Diseases
Body Weight Changes
Nutrition Disorders
Breast Neoplasms
Overnutrition
Overweight
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 23, 2008




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