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Completed

NCT Number: NCT00359060

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

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.

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Key information

Age range

50 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Center Utrecht, Julius Center

Utrecht, 3508 GA, Netherlands

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Dutch Cancer Society
  • National Institute for Public Health and the Environment (RIVM)

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Aug 1, 2006
Registry last updated
Oct 13, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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