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:	Fred Hutchinson Cancer Research Center
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
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 Diabetes Medicines Exercise and Physical Fitness Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Serum estrone concentrations as measured by radioimmunoassay [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum estradiol and free estradiol concentration as measured by radioimmunoassay [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]
Testosterone and free testosterone as measured radioimmunoassay [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]
Serum concentrations of Sex hormone binding globulin measured using immunoassays [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]
Mammographic density measurements (i.e., percentage density and dense area of breast tissue) [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]
Change in weight and body mass index (Anthropometrics) [ Time Frame: At baseline and 12 months timepoint ] [ 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 [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]
Quality of life (assessed via questionnaires) [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]
Change in daily caloric intake as measured by Food Frequency Questionnaire [ Time Frame: At baseline and 12 months timepoint ] [ Designated as safety issue: No ]
Leukocyte and Neutrophil Counts [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum concentrations of Insulin as measured radioimmunoassay [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Serum concentrations of Glucose as measured radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum concentrations of Insulin-like growth factor-1 [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum concentrations of Insulin-like growth-factor binding protein-3 [ Time Frame: Baseline and 12-month timepoints ] [ Designated as safety issue: No ]
Serum Vitamin D concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum ghrelin concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum C-reactive Protein (CRP) concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum concentrations of Serum Amyloid A (SAA) as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum interleukin-6 (IL-6) concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum adiponectin concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum leptin concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum androtenedione concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]
Serum c-peptide concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ] [ Designated as safety issue: No ]

Enrollment:	439
Study Start Date:	December 2004
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control
Caloric Restriction Nutritionist-delivered weight loss intervention though diet modification with an aim of 10% weightloss over a year long intervention based on the DPP and LookAHEAD interventions. Participants meet with a nutritionist individually and in small groups. Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study.	Behavioral: behavioral dietary intervention A group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss Other Name: Weight Loss interventions
Exercise Intervention Participants exercise 3 days per week under the supervision of a physiologist and 2 days per week independently at home, for a total of 5 exercise sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12 months	Behavioral: Exercise intervention Facility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week
Caloric Restriction AND Exercise Intervention Combined caloric restriction & exercise intervention	Behavioral: behavioral dietary intervention A group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss Other Name: Weight Loss interventions Behavioral: Exercise intervention Facility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week

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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
Seattle, Washington, United States, 98109-1024

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 by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mason C, Xiao L, Imayama I, Duggan CR, Bain C, Foster-Schubert KE, Kong A, Campbell KL, Wang CY, Neuhouser ML, Li L, W Jeffery R, Robien K, Alfano CM, Blackburn GL, McTiernan A. Effects of weight loss on serum vitamin D in postmenopausal women. Am J Clin Nutr. 2011 Jul;94(1):95-103. Epub 2011 May 25.

Responsible Party:	Anne McTiernan, MD PhD, FHCRC
ClinicalTrials.gov Identifier:	NCT00470119 History of Changes
Other Study ID Numbers:	PHS 1960.00, U54CA116847, P50CA083636, P30CA015704, FHCRC-PHS-1960.00, FHCRC-1960, CDR0000544634
Study First Received:	May 3, 2007
Last Updated:	October 4, 2011
Health Authority:	United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:

breast cancer
obesity
weight changes

Additional relevant MeSH terms:

Body Weight Changes
Breast Neoplasms
Obesity
Body Weight
Signs and Symptoms
Neoplasms by Site

Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on February 12, 2012