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Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study

This study has been completed.
Sponsor:
Collaborators:
National Institute for Public Health and the Environment (RIVM)
Dutch Cancer Society
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00359060
First received: July 31, 2006
Last updated: October 12, 2006
Last verified: July 2006
History of Changes
  Purpose

Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone levels.


Condition Intervention Phase
Breast Cancer
 Behavioral: Physical activity
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate
  • Serum concentrations of endogenous androgens: testosterone, androstenedione
  • Serum concentrations of sex hormone binding globulin
  • Serum concentrations of fasting insulin
  • Insulin sensitivity

Secondary Outcome Measures:
  • Amount of total body fat and intra-abdominal fat
  • Weight
  • Body Mass Index (BMI)
  • Body fat distribution
  • Waist to hip ratio
  • Physical Fitness
  • Blood pressure
  • Lifestyle parameters (covariates)
  • Exercise behaviour (habitual physical activity, past week activity, physical activity in the past)
  • Diet (daily caloric intake; percent daily calories from fat, carbohydrates and proteins)
  • Alcohol consumption
  • Medication use
  • Reproductive factors
  • Medical history

Estimated Enrollment: 180
Study Start Date: January 2005
Estimated Study Completion Date: September 2006
Detailed Description:

Physical activity has been associated with a decreased risk for breast cancer. The biological mechanism(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical activity prevents overweight and abdominal adiposity.

In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strength training exercise programme. Participants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globulin and insulin. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.

This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 50 –69 year
  • > 12 months since last menses
  • Non-smokers (at least 12 months)
  • Sedentary
  • Knowledge of the Dutch language
  • Agreement to be randomly assigned to either the exercise intervention or control group
  • Informed consent to participate in all screening and study activities

Exclusion Criteria:

  • Use of hormone replacement or oral contraceptives in past 6 months
  • Morbidly obese (BMI > 40)
  • BMI < 22
  • Currently on or planning to go on a strict diet
  • Ever diagnosed with breast cancer
  • Diagnosis of other types of cancer in the past 5 years
  • Diabetes mellitus or other endocrine related diseases
  • Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
  • Alcohol or drug abuse
  • Maintenance use of corticosteroids
  • Use of beta blockers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359060

Locations
Netherlands
University Medical Center Utrecht, Julius Center
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
National Institute for Public Health and the Environment (RIVM)
Dutch Cancer Society
Investigators
Principal Investigator: Jantine Schuit, PhD Dutch Institute of Public Health and the Environment
Principal Investigator: Petra HM Peeters, PhD University Medical Center Utrecht, Julius Center
  More Information

No publications provided by UMC Utrecht

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

ClinicalTrials.gov Identifier: NCT00359060     History of Changes
Other Study ID Numbers: UU 2003-2793
Study First Received: July 31, 2006
Last Updated: October 12, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Physical activity
Sex steroid hormones
Breast cancer risk
Intervention study
Postmenopausal women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013