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

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

Tracking Information
First Submitted Date  ICMJE July 31, 2006
First Posted Date  ICMJE August 1, 2006
Last Update Posted Date October 13, 2006
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
Official Title  ICMJE Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE Behavioral: Physical activity
Study Arms  ICMJE Not Provided
Publications * Monninkhof EM, Peeters PH, Schuit AJ. Design of the sex hormones and physical exercise (SHAPE) study. BMC Public Health. 2007 Sep 4;7:232.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 31, 2006)
180
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359060
Other Study ID Numbers  ICMJE UU 2003-2793
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE
  • National Institute for Public Health and the Environment (RIVM)
  • Dutch Cancer Society
Investigators  ICMJE
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
PRS Account UMC Utrecht
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP