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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
E.M. Monninkhof, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01511276
First received: January 12, 2012
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Breast Cancer Risk
Behavioral: Diet
Behavioral: Combined exercise- + diet-induced weight loss

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • serum sex hormone levels [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
    Estradiol (total, free), estrone, testosterone, sex hormone binding globulin.


Secondary Outcome Measures:
  • anthropometrics and physical fitness. [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 250
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet-induced weight loss
The diet-induced weight loss group will follow a calorie restricted diet. They are asked to keep their habitual sedentary lifestyle. The aim of this group is to loose 5-6 kg of body weight in 14 weeks time.
Behavioral: Diet
Energy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day.
Experimental: Combined exercise- + diet-induced weight loss

Participants in the exercise- plus diet-induced weight loss group are enrolled in an exercise programme. Next to the exercise programme, they will follow a calorie restricted diet.

The aim of this group is to loose 5-6 kg of body weight in 14 weeks time.

Behavioral: Combined exercise- + diet-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.

No Intervention: Control, stable weight
The control group is asked to follow a baseline isocaloric diet and to not change their habitual sedentary lifestyle.

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 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.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511276

Locations
Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7500 KA
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
  More Information

No publications provided

Responsible Party: E.M. Monninkhof, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01511276     History of Changes
Other Study ID Numbers: 11-465
Study First Received: January 12, 2012
Last Updated: May 6, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Breast cancer
Sex hormones
Physical activity

Additional relevant MeSH terms:
Weight Loss
Breast Neoplasms
Body Weight Changes
Body Weight
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014