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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00470119
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE May 3, 2007
First Posted Date  ICMJE May 7, 2007
Last Update Posted Date September 10, 2012
Study Start Date  ICMJE December 2004
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2010)
Serum estrone concentrations as measured by radioimmunoassay [ Time Frame: At baseline and 12 months timepoint ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Serum estrone concentrations as measured by radioimmunoassay at 12 months
Change History Complete list of historical versions of study NCT00470119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
  • Serum estradiol and free estradiol concentration as measured by radioimmunoassay [ Time Frame: At baseline and 12 months timepoint ]
  • Testosterone and free testosterone as measured radioimmunoassay [ Time Frame: At baseline and 12 months timepoint ]
  • Serum concentrations of Sex hormone binding globulin measured using immunoassays [ Time Frame: At baseline and 12 months timepoint ]
  • Mammographic density measurements (i.e., percentage density and dense area of breast tissue) [ Time Frame: At baseline and 12 months timepoint ]
  • Change in weight and body mass index (Anthropometrics) [ Time Frame: At baseline and 12 months timepoint ]
  • 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 ]
  • Quality of life (assessed via questionnaires) [ Time Frame: At baseline and 12 months timepoint ]
  • Change in daily caloric intake as measured by Food Frequency Questionnaire [ Time Frame: At baseline and 12 months timepoint ]
  • Leukocyte and Neutrophil Counts [ Time Frame: Baseline and 12 month timepoints ]
  • Serum concentrations of Insulin as measured radioimmunoassay [ Time Frame: Baseline and 12 months ]
  • Serum concentrations of Glucose as measured radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum concentrations of Insulin-like growth factor-1 [ Time Frame: Baseline and 12 month timepoints ]
  • Serum concentrations of Insulin-like growth-factor binding protein-3 [ Time Frame: Baseline and 12-month timepoints ]
  • Serum Vitamin D concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum ghrelin concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum C-reactive Protein (CRP) concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum concentrations of Serum Amyloid A (SAA) as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum interleukin-6 (IL-6) concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum adiponectin concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum leptin concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum androtenedione concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
  • Serum c-peptide concentrations as measured by radioimmunoassay [ Time Frame: Baseline and 12 month timepoints ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Serum estradiol and free estradiol concentration as measured by radioimmunoassay at 12 months
  • Testosterone and free testosterone as measured at 12 months
  • Sex hormone binding globulin as measured at 12 months
  • Insulin and insulin-like growth factor (IGF)-1 as measured at 12 months
  • IGF binding protein-3 as measured at 12 months
  • Mammographic density (i.e., percentage density and dense area) as measured at 12 months
  • Weight and body mass index as measured at 12 months
  • 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
  • Quality of life as measured at baseline, 6 months, and 12 months
  • Change in daily caloric intake as measured by Food Frequency Questionnaire at baseline, 6 months, and 12 months
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women
Official Title  ICMJE Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

  • Compare the effects of a 1-year exercise intervention, reduced-calorie diet intervention, or a combined exercise and reduced-calorie diet intervention vs no intervention on serum estrone concentrations in overweight or obese postmenopausal women.

Secondary

  • Compare the effects of these interventions on serum levels of estradiol and free estradiol in these participants.
  • Compare the effects of these interventions on serum levels of testosterone and free testosterone in these participants.
  • Compare the effects of these interventions on serum levels of sex hormone binding globulin in these participants.
  • Compare the effects of these interventions on serum levels of insulin in these participants.
  • Compare the effects of these interventions on serum levels of glucose in these participants.
  • Compare the effects of these interventions on serum levels of c-peptide in these participants.
  • Compare the effects of these interventions on serum levels of insulin-like growth factor I (IGF-1) in these participants.
  • Compare the effects of these interventions on serum levels of insulin-like growth factor binding-protein-3 (IGFBP-3) in these participants.
  • Compare the effects of these interventions on serum levels of c-reactive protein (CRP) in these participants.
  • Compare the effects of these interventions on serum levels of serum amyloid protein A (SAA) in these participants.
  • Compare the effects of these interventions on serum levels of interleukin-6 (IL-6) in these participants.
  • Compare the effects of these interventions on serum levels of adiponectin in these participants.
  • Compare the effects of these interventions on serum levels of leptin in these participants.
  • Compare the effects of these interventions on serum levels of ghrelin in these participants.
  • Compare the effects of these interventions on serum levels of Vitamin D in these participants.
  • Compare the effects of these interventions on mammographic density in these participants.
  • Compare the effects of these interventions on anthropometrics and body composition (i.e., weight, body mass index, total and percentage body fat, and waist and hip circumferences) in these participants.
  • Compare the effects of these interventions on quality of life in these participants.
  • Compare the effects of these interventions on numbers of leukocytes and neutrophiles in these participants.
  • Compare the effects of these interventions on VO2max in these participants.

OUTLINE: This is a randomized study. Participants are stratified according to body mass index (< 30 vs ≥ 30). Participants are randomized to 1 of 4 intervention arms.

  • Arm I (exercise program): 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.
  • Arm II (reduced-calorie diet): 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.
  • Arm III (exercise program and reduced-calorie diet): Participants meet with a physiologist and a nutritionist, as in arms I and II, and exercise and diet accordingly.
  • Arm IV (control: delayed diet and exercise): Participants receive study materials on healthy diet and exercise at the end of the 12-month study period. In addition, participants are offered 2 months of group exercise training with a study physiologist and 4 group meetings with a nutritionist to learn about weight loss techniques and behavioral principles for achieving weight loss.

All participants undergo testing at baseline and periodically during study. Participants undergo blood collection for evaluation of serum levels of sex and metabolic hormones (e.g., estrone, estradiol, testosterone, free testosterone, and sex hormone binding globulin, radioimmunoassay and other immunoassays. Participants also undergo anthropometrics and body composition measurements and mammographic density assessment.

Participants complete questionnaires at baseline and at 6 and 12 months for assessment of diet and exercise. Quality of life (QOL) is measured at baseline and at 6 and 12 months using the Medical Outcomes Study 36-Item Short Form and the Impact of Weight on QOL questionnaire. Information on health habits, medical history, family history of breast cancer, and reproductive and menstrual history is also collected.

FINAL ACCRUAL: A total of 439 participants (118 in the caloric restriction arm, and 117 in both the CR+Exercise, and exercise only arm; and 87 in control arm) were accrued for this study.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Breast Cancer
  • Obesity
  • Weight Changes
Intervention  ICMJE
  • 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
Study Arms
  • 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.
    Intervention: Behavioral: behavioral dietary intervention
  • 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
    Intervention: Behavioral: Exercise intervention
  • Caloric Restriction AND Exercise Intervention
    Combined caloric restriction & exercise intervention
    Interventions:
    • Behavioral: behavioral dietary intervention
    • Behavioral: Exercise intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2010)
439
Original Enrollment  ICMJE
 (submitted: May 3, 2007)
503
Actual Study Completion Date February 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00470119
Other Study ID Numbers  ICMJE PHS 1960.00
U54CA116847 ( U.S. NIH Grant/Contract )
P50CA083636 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
FHCRC-PHS-1960.00
FHCRC-1960
CDR0000544634 ( Registry Identifier: PDQ )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anne McTiernan, MD PhD, FHCRC
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Anne McTiernan, MD, PhD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP