Breast CancerPhase 3NCT00359060
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
A Phase 3 study testing Physical activity in people with Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2005to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht, Julius Center
Utrecht, 3508 GA
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Physical activity
- Keywords
- Physical activity, Sex steroid hormones, Breast cancer risk, Intervention study, Postmenopausal women
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (14)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJan 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), Dutch Cancer Society
- Investigators
- Jantine Schuit, PhD, Principal investigator, Dutch Institute of Public Health and the EnvironmentPetra HM Peeters, PhD, Principal investigator, University Medical Center Utrecht, Julius Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359060
- Sponsor's protocol ID
- UU 2003-2793
- Status last verified
- Jul 2006
- First submitted
- 31 Jul 2006
- Last updated
- 13 Oct 2006
- Results posted
- No
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. doi: 10.1186/1471-2458-7-232.
PubMed 17767724
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
- ClinicalTrials.gov ID
- NCT00359060
- Acronym / sponsor ID
- UU 2003-2793
- Conditions
- Breast Cancer
- Keywords
- Physical activity, Sex steroid hormones, Breast cancer risk, Intervention study, Postmenopausal women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), Dutch Cancer Society
- Study start
- Jan 2005
- Study completion
- Sep 2006
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 50 -69 year
- > 12 months since last menses
- Non-smokers (at least 12 months)
- Sedentary
- Knowledge of the Dutch language
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity | Behavioural | – |
Primary outcome
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
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2006.
- Derived from this study: PubMed 17767724Monninkhof 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jantine Schuit, PhD principal investigator
Dutch Institute of Public Health and the Environment
Petra HM Peeters, PhD principal investigator
University Medical Center Utrecht, Julius Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physical activity in people with Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00359060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2006.