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

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

Tracking Information

• First Submitted Date: July 31, 2006
• First Posted Date: August 1, 2006
• Last Update Posted Date: October 13, 2006
• Study Start Date: January 2005
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Prevention
• Condition: Breast Cancer
• Intervention: Behavioral: Physical activity
• Study Arms: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: July 31, 2006): 180
• Original Enrollment: Same as current
• Study Completion Date: September 2006
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 50 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00359060
• Other Study ID Numbers: UU 2003-2793
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: UMC Utrecht

Collaborators

• 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

• PRS Account: UMC Utrecht
• Verification Date: July 2006