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

Phase 3
50 Years
69 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Outcome Measure:

Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate

Principal Investigator

Jantine Schuit, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dutch Institute of Public Health and the Environment


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

UU 2003-2793



Start Date:

January 2005

Completion Date:

September 2006

Related Keywords:

  • Breast Cancer
  • Physical activity
  • Sex steroid hormones
  • Breast cancer risk
  • Intervention study
  • Postmenopausal women
  • Breast Neoplasms