The effects of equivalent weight loss with or without exercise programme on breast cancer risk biomarkers in postmenopausal women: the SHAPE-2 study.

Completed

• Conditions: breast cancer; 10006291; breast neoplasm

• Registration Number: NL-OMON38377
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Female. 50-69 years of age. Postmenopausal (>12 months after last menses). BMI 25-35 kg/m2. Inactive (<2 hours per week of at least moderately intensive activities (>4 MET)). Willing to be randomly assigned to one of the three study arms.

Exclusion Criteria

Use of sex hormones in the past 12 months. Suffering from breastcancer (in medical history) or other cancers in the last 5 years, except for non-melanoma skin cancers. Suffering from type II diabetes mellitus or other endocrine related diseases. Smoker.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sex-hormone levels: estradiol, estrone, testosterone, sex hormone binding<br /><br>globulin (SHBG). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Physical fitness, anthropometrics, the amount of total body fat (DEXA scan) and<br /><br>abdominal fat (MRI).<br /><br>We also measure lifestyle factors: i.e. habitual physical activity, dietary<br /><br>pattern, alcohol consumption and medication use. </p><br>