MedDataX Logo

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

NCT ID: NCT00359060

Last Updated: 2006-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Physical activity Sex steroid hormones Breast cancer risk Intervention study Postmenopausal women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Public Health and the Environment (RIVM)

OTHER_GOV

Sponsor Role collaborator

Dutch Cancer Society

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jantine Schuit, PhD

Role: PRINCIPAL_INVESTIGATOR

Dutch Institute of Public Health and the Environment

Petra HM Peeters, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht, Julius Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Utrecht, Julius Center

Utrecht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

Monninkhof EM, Peeters PH, Schuit AJ. Design of the sex hormones and physical exercise (SHAPE) study. BMC Public Health. 2007 Sep 4;7:232. doi: 10.1186/1471-2458-7-232.

Reference Type DERIVED
PMID: 17767724 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UU 2003-2793

Identifier Type: -

Identifier Source: org_study_id