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

October 12, 2006 updated by: UMC Utrecht

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • University Medical Center Utrecht, Julius Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Insulin sensitivity
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

Secondary Outcome Measures

Outcome Measure
Blood pressure
Weight
Body Mass Index (BMI)
Medication use
Physical Fitness
Amount of total body fat and intra-abdominal fat
Body fat distribution
Waist to hip ratio
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
Reproductive factors
Medical history

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

July 31, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Estimate)

October 13, 2006

Last Update Submitted That Met QC Criteria

October 12, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU 2003-2793

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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