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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359060
• Other study ID #: UU 2003-2793
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2006
• Last updated: October 12, 2006
• Start date: January 2005
• Est. completion date: September 2006

Study information

• Verified date: July 2006
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Physical activity

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht, Julius Center	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Dutch Cancer Society, National Institute for Public Health and the Environment (RIVM)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate
Primary	Serum concentrations of endogenous androgens: testosterone, androstenedione
Primary	Serum concentrations of sex hormone binding globulin
Primary	Serum concentrations of fasting insulin
Primary	Insulin sensitivity
Secondary	Amount of total body fat and intra-abdominal fat
Secondary	Weight
Secondary	Body Mass Index (BMI)
Secondary	Body fat distribution
Secondary	Waist to hip ratio
Secondary	Physical Fitness
Secondary	Blood pressure
Secondary	Lifestyle parameters (covariates)
Secondary	Exercise behaviour (habitual physical activity, past week activity, physical activity in the past)
Secondary	Diet (daily caloric intake; percent daily calories from fat, carbohydrates and proteins)
Secondary	Alcohol consumption
Secondary	Medication use
Secondary	Reproductive factors
Secondary	Medical history