Status:
COMPLETED
The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2)
Lead Sponsor:
UMC Utrecht
Conditions:
Breast Cancer Risk
Eligibility:
FEMALE
50-69 years
Phase:
NA
Brief Summary
Physical inactivity and overweight are two accepted risk factors for breast cancer. However, because of their correlation it is not clear which is most relevant to risk. The investigators now set out ...
Detailed Description
Postmenopausal women who are sedentary or overweight, have an increased breast cancer risk. It is suggested that these two factors mediate breast cancer risk mainly through sex hormone-related pathway...
Eligibility Criteria
Inclusion
- Female
- 50-69 years of age
- Postmenopausal (\>12 months after last menses)
- BMI 25-35 kg/m2
- Sedentary (\<2 hours per week of at least moderately intensive activities (\>4 MET))
- Willing to be randomly assigned to one of the three study arms
- Informed consent to participate in all screening and study activities.
Exclusion
- Presently using sex-hormones
- Maintenance use of corticosteroids
- Suffering cancer (in medical history) except for non-melanoma skin cancers
- Suffering type II diabetes mellitus or other endocrine related diseases
- Smoking
- Alcohol or drug abuse
- Any disorder that might impede participation in the exercise programme
- Following, or the intention to follow, a structured weight loss programme elsewhere
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01511276
Start Date
February 1 2012
End Date
October 1 2014
Last Update
May 5 2017
Active Locations (2)
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1
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7500 KA
2
UMC Utrecht
Utrecht, Netherlands, 3584 CX