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Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)


N/A
50 Years
75 Years
Not Enrolling
Female
Breast Cancer, Obesity, Weight Changes

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Trial Information

Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

Serum estrone concentrations as measured by radioimmunoassay

Outcome Time Frame:

At baseline and 12 months timepoint

Safety Issue:

No

Principal Investigator

Anne McTiernan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

PHS 1960.00

NCT ID:

NCT00470119

Start Date:

December 2004

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • Obesity
  • Weight Changes
  • breast cancer
  • obesity
  • weight changes
  • Body Weight Changes
  • Breast Neoplasms
  • Obesity

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109