Breast Cancer RiskSHAPE-2NCT01511276
The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2)
A study testing Diet and Mainly exercise induced weight loss in people with Breast Cancer Risk, run by UMC Utrecht at 2 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Risk
- What is being tested?
- Diet and Mainly exercise induced weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medisch Spectrum Twente
Enschede, Overijssel, 7500 KA
UMC Utrecht
Utrecht, 3584 CX
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Risk
- Being tested
- Diet, Mainly exercise induced weight loss
- Keywords
- Breast cancer, Sex hormones, Physical activity
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
Energy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day.
Mainly exercise induced weight lossBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet-induced weight loss | Experimental | 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. Receives: Behavioral: Diet |
| Mainly exercise induced weight loss | Experimental | 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. Receives: Behavioral: Mainly exercise induced weight loss |
| Control, stable weight | No intervention | The control group is asked to follow a baseline isocaloric diet and to not change their habitual sedentary lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum sex hormone levels
Estradiol (total, free), estrone, testosterone, sex hormone binding globulin.
Measured: 21 weeks
Secondary outcomes (1)
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).
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer RiskStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.M. Monninkhof, UMC Utrecht
- Investigators
- evelyn Monninkhof, PhD, Principal investigator, UMC Utrecht, Julius Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511276
- Sponsor's protocol ID
- 11-465
- Acronym
- SHAPE-2
- Status last verified
- May 2017
- First submitted
- 12 Jan 2012
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23972905van 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.
PubMed 26029921van 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.
PubMed 26330303van 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.
PubMed 26908432de 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.
PubMed 27981025van 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.
PubMed 30744621
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01511276
- Acronym / sponsor ID
- SHAPE-2 / 11-465
- Conditions
- Breast Cancer Risk
- Keywords
- Breast cancer, Sex hormones, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet-induced weight loss | Experimental | Behavioral: DietThe 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. |
| Mainly exercise induced weight loss | Experimental | Behavioral: Mainly exercise induced weight lossParticipants 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. |
| Control, stable weight | No intervention | –The control group is asked to follow a baseline isocaloric diet and to not change their habitual sedentary lifestyle. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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))
Key exclusion criteria (8 listed)
- Presently using sex-hormones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietEnergy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day. | Behavioural | Diet-induced weight loss |
| Mainly exercise induced weight lossExercise 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. | Behavioural | Mainly exercise induced weight loss |
Primary outcome
serum sex hormone levels
Time frame: 21 weeks
Estradiol (total, free), estrone, testosterone, sex hormone binding globulin.
1 secondary outcome
anthropometrics and physical fitness.
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 23972905van 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.
- Results publication: PubMed 26029921van 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.
- Results publication: PubMed 26330303van 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.
- Results publication: PubMed 26908432van 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.
- Results publication: PubMed 27981025de 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.
- Derived from this study: PubMed 30744621van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
evelyn Monninkhof, PhD principal investigator
UMC Utrecht, Julius Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Mainly exercise induced weight loss in people with Breast Cancer Risk, run by UMC Utrecht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum sex hormone levels (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01511276, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.