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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00470119

Collaborator

National Cancer Institute (NCI) (NIH)

439

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Obesity Weight Changes	Behavioral: behavioral dietary intervention Behavioral: Exercise intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

439 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control
Other: 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 Names: Weight Loss interventions
Other: 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
Other: 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 Names: 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

Outcome Measures

Primary Outcome Measures

Serum estrone concentrations as measured by radioimmunoassay [At baseline and 12 months timepoint]

Secondary Outcome Measures

Serum estradiol and free estradiol concentration as measured by radioimmunoassay [At baseline and 12 months timepoint]
Testosterone and free testosterone as measured radioimmunoassay [At baseline and 12 months timepoint]
Serum concentrations of Sex hormone binding globulin measured using immunoassays [At baseline and 12 months timepoint]
Mammographic density measurements (i.e., percentage density and dense area of breast tissue) [At baseline and 12 months timepoint]
Change in weight and body mass index (Anthropometrics) [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 [At baseline and 12 months timepoint]
Quality of life (assessed via questionnaires) [At baseline and 12 months timepoint]
Change in daily caloric intake as measured by Food Frequency Questionnaire [At baseline and 12 months timepoint]
Leukocyte and Neutrophil Counts [Baseline and 12 month timepoints]
Serum concentrations of Insulin as measured radioimmunoassay [Baseline and 12 months]
Serum concentrations of Glucose as measured radioimmunoassay [Baseline and 12 month timepoints]
Serum concentrations of Insulin-like growth factor-1 [Baseline and 12 month timepoints]
Serum concentrations of Insulin-like growth-factor binding protein-3 [Baseline and 12-month timepoints]
Serum Vitamin D concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum ghrelin concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum C-reactive Protein (CRP) concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum concentrations of Serum Amyloid A (SAA) as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum interleukin-6 (IL-6) concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum adiponectin concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum leptin concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum androtenedione concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]
Serum c-peptide concentrations as measured by radioimmunoassay [Baseline and 12 month timepoints]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024

Sponsors and Collaborators

Fred Hutchinson Cancer Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Anne McTiernan, MD, PhD, Fred Hutchinson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00470119

Other Study ID Numbers:

PHS 1960.00
U54CA116847
P50CA083636
P30CA015704
FHCRC-PHS-1960.00
FHCRC-1960
CDR0000544634

First Posted:

May 7, 2007

Last Update Posted:

Sep 10, 2012

Last Verified:

Sep 1, 2012

Keywords provided by , ,

breast cancer

obesity

weight changes

Additional relevant MeSH terms:

Breast Neoplasms

Body Weight Changes

Study Results

No Results Posted as of Sep 10, 2012