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 has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00470119
First received: May 3, 2007
Last updated: September 7, 2012
Last verified: September 2012
  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:


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
Study Completion Date: February 2010
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 7, 2012
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 July 20, 2014