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

UMC Utrecht

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Behavioral: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT00359060

UU 2003-2793

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

50 to 69 years old

Volunteers

Accepts Healthy Volunteers

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