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

Breast Cancer Risk Clinical Trial

— SHAPE-2  

Official title:

The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk Biomarkers in Postmenopausal Women: the SHAPE-2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511276
• Other study ID #: 11-465
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: May 2, 2017
• Start date: February 2012
• Est. completion date: October 2014

Study information

• Verified date: May 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 pathways. However, an inactive lifestyle and obesity are highly correlated and it is not clear which is most relevant to risk.

Literature shows that weight loss/ fat loss reduces postmenopausal sex hormone levels, but the question is if there is an additional beneficial effect on hormones of reaching this weight loss by physical activity instead of nutritional interventions.

In this three-armed, two-center intervention study, 250 sedentary postmenopausal women who are aged 50-69 years will first enter a run-in period of 5 weeks. During this period, all participants get a diet, adapted to the guidelines for healthy nutrition, meeting their energy expenditures to maintain stable weight. After this run-in phase they are randomly allocated to a (1) diet induced weight loss group, (2) a combined exercise and diet induced weight loss group or (3) a control group. Participants allocated to the dietgroup will get a calorie restricted diet of -500 kCal/day, they will remain their habitual exercise pattern. Participants in the combined group will follow an exercise programme (combined endurance and strength) of 4 hours of sports per week with an average energy expenditure of 350 kCal/day and a, less strict. And a calorie restricted diet of -250 kCal/day. The aim of both intervention groups is to loose 5-6 kg of body weight during the 14 week intervention period. Participants in the control group are requested to retain the baseline diet and their habitual exercise pattern. Primary study parameters measured at baseline and after 21 weeks are: serum concentrations of endogenous estrogens, endogenous androgens and sex hormone binding globulin. Other study parameters include: body fat distribution, amount of total and abdominal fat, weight, BMI, physical fitness, blood pressure and lifestyle factors.

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. Furthermore, we are specifically interested whether weight loss mainly due to physical exercise induces greater amounts of fat loss (total and abdominal) and subsequently results in more favourable effects on these hormones compared to equivalent diet-induced weight loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: October 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Risk
• Breast Neoplasms
• Weight Loss

Intervention

Behavioral:
• Diet
Energy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day.
• Mainly exercise induced weight loss
Exercise programme of 2 hours per week fitness containing endurance and resistance training. And 2 hours of Nordic Walking. Equivalent to an energy expenditure of 350 kCal/day. Next to the exercise programme participants will follow an energy restricted diet according to the national guidelines of healthy nutrition creating an extra energy deficit of 250 kCal/day.

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

de 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. eCollection 2017 Mar. — View Citation

van 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. — View Citation

van 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 Bi — View Citation

van 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 S — View Citation

van 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 On — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum sex hormone levels	Estradiol (total, free), estrone, testosterone, sex hormone binding globulin.	21 weeks
Secondary	anthropometrics and physical fitness.	BMI, weight, waist- and hip-circumference, total body fat (DEXA scan), abdominal fat (subcutaneous and visceral, MRI-abdomen) and physical fitness (maximal exercise capacity test by the ramp protocol).	21 weeks