The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2)

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 to study whether physical activity in addition to weight loss by diet only, affects sex hormone levels, known to be related to breast cancer risk. In the SHAPE-2 study 250 healthy overweight/obese and physically inactive women are randomly allocated to a diet-induced weight loss group, a combined exercise- and diet-induced weight loss group or a control group. The aim of the first two intervention groups is to loose 5-6 kg of bodyweight, either by dieting or mainly by increased physical activity. Measurements are performed at baseline and after 21 weeks, the end of the study period. The aim of this study is to provide insight into the effect of weight loss mainly driven by exercise compared to equivalent weight loss due to nutritional calorie restriction on breast cancer biomarkers.

Sex

Female

Minimum age

50 Years

Maximum age

69 Years

Inclusion Criteria:

* 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 Criteria:

* 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

• BACKGROUNDvan Gemert WA, Iestra JI, Schuit AJ, May AM, Takken T, Veldhuis WB, van der Palen J, Wittink H, Peeters PH, Monninkhof EM. Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk. BMC Cancer. 2013 Aug 23;13:395. doi: 10.1186/1471-2407-13-395. PMID 23972905
• RESULTvan Gemert WA, van der Palen J, Monninkhof EM, Rozeboom A, Peters R, Wittink H, Schuit AJ, Peeters PH. Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial. PLoS One. 2015 Jun 1;10(6):e0127520. doi: 10.1371/journal.pone.0127520. eCollection 2015. PMID 26029921
• RESULTvan Gemert WA, Schuit AJ, van der Palen J, May AM, Iestra JA, Wittink H, Peeters PH, Monninkhof EM. Effect of weight loss, with or without exercise, on body composition and sex hormones in postmenopausal women: the SHAPE-2 trial. Breast Cancer Res. 2015 Sep 2;17(1):120. doi: 10.1186/s13058-015-0633-9. PMID 26330303
• RESULTvan Gemert WA, May AM, Schuit AJ, Oosterhof BY, Peeters PH, Monninkhof EM. Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women: The SHAPE-2 Trial, A Randomized Controlled Trial. Cancer Epidemiol Biomarkers Prev. 2016 May;25(5):799-806. doi: 10.1158/1055-9965.EPI-15-1065. Epub 2016 Feb 16. PMID 26908432
• RESULTde Roon M, van Gemert WA, Peeters PH, Schuit AJ, Monninkhof EM. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women: A randomized trial. Prev Med Rep. 2016 Dec 9;5:118-123. doi: 10.1016/j.pmedr.2016.12.006. eCollection 2017 Mar. PMID 27981025
• DERIVEDvan Gemert WA, Peeters PH, May AM, Doornbos AJH, Elias SG, van der Palen J, Veldhuis W, Stapper M, Schuit JA, Monninkhof EM. Effect of diet with or without exercise on abdominal fat in postmenopausal women - a randomised trial. BMC Public Health. 2019 Feb 11;19(1):174. doi: 10.1186/s12889-019-6510-1.