Clinical trial · Interventional
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
NCT00359060CI-TRIAL-00000478completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate
- measure
- Serum concentrations of endogenous androgens: testosterone, androstenedione
- measure
- Serum concentrations of sex hormone binding globulin
- measure
- Serum concentrations of fasting insulin
- measure
- Insulin sensitivity
Secondary outcomes (14)
- measure
- Amount of total body fat and intra-abdominal fat
- measure
- Weight
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMonninkhof 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. PMID 17767724