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

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. Identifier: NCT00359060
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : October 13, 2006
National Institute for Public Health and the Environment (RIVM)
Dutch Cancer Society
Information provided by:
UMC Utrecht

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Behavioral: Physical activity Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
Study Start Date : January 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Amount of total body fat and intra-abdominal fat
  2. Weight
  3. Body Mass Index (BMI)
  4. Body fat distribution
  5. Waist to hip ratio
  6. Physical Fitness
  7. Blood pressure
  8. Lifestyle parameters (covariates)
  9. Exercise behaviour (habitual physical activity, past week activity, physical activity in the past)
  10. Diet (daily caloric intake; percent daily calories from fat, carbohydrates and proteins)
  11. Alcohol consumption
  12. Medication use
  13. Reproductive factors
  14. Medical history

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00359060

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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
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00359060    
Other Study ID Numbers: UU 2003-2793
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: October 13, 2006
Last Verified: July 2006
Keywords provided by UMC Utrecht:
Physical activity
Sex steroid hormones
Breast cancer risk
Intervention study
Postmenopausal women
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases