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

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	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	Behavioral: behavioral dietary intervention Behavioral: exercise intervention Dietary Supplement: dietary intervention Other: educational intervention Other: laboratory biomarker analysis Other: preventative dietary intervention Procedure: complementary or alternative medicine procedure Procedure: evaluation of cancer risk factors Procedure: immunoscintigraphy Procedure: quality-of-life assessment Procedure: radiomammography

Condition

Intervention

Breast Cancer
Obesity
Weight Changes

Behavioral: behavioral dietary intervention
Behavioral: exercise intervention
Dietary Supplement: dietary intervention
Other: educational intervention
Other: laboratory biomarker analysis
Other: preventative dietary intervention
Procedure: complementary or alternative medicine procedure
Procedure: evaluation of cancer risk factors
Procedure: immunoscintigraphy
Procedure: quality-of-life assessment
Procedure: radiomammography

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

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

U.S. FDA Resources

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

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: Contact Person 206-667-6444 new@fhcrc.org

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Anne McTiernan, MD, PhD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000544634, FHCRC-PHS-1960.00, FHCRC-1960
Study First Received:	May 3, 2007
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00470119 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer
obesity
weight changes

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Neoplasms
Neoplasms by Site
Skin Diseases

Body Weight Changes
Nutrition Disorders
Breast Neoplasms
Overweight
Overnutrition
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009