Contact information
Type
Scientific
Primary contact
Dr Evelyn Monninkhof
ORCID ID
Contact details
University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509379
e.monninkhof@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SHAPE: Sex Hormones and Physical Exercise
Study hypothesis
We hypothesise that exercise may reduce risk of breast cancer, either directly or indirectly through a reduction in abdominal fat mass, by favouring the sex hormone profile and decreased insulin. Because the association between breast cancer and endogenous estrogens is rather convincing, we designed the Sex Hormones and Physical Exercise (SHAPE) study on the effects of physical activity on these hormones.
Furthermore, since androgens and insulin are suspicious risk factors for breast cancer, the effects of physical activity on these hormone levels are also investigated. Since the intervention programme is aimed at maximising fat loss, we can also investigate whether a potential relation between physical activity and endogenous hormones is mediated by the amount of total body fat or abdominal fat. If change in exercise level has a beneficial effect on the sex hormone and metabolic profile of postmenopausal women, increasing exercise is a possible breast cancer protective intervention.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Reducing the risk of breast cancer
Intervention
1. Intervention group: participants in this group will participate in an one year moderate intensity exercise programme
2. Control group: participants in this group will receive care as usual
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Endogenous hormone levels (sex steroid hormones, insulin).
Secondary outcome measures
1. Physical fitness, weight and the amount of total and intra-abdominal fat
2. Lifestyle factors: habitual physical activity, diet, alcohol consumption and medication use
Overall trial start date
01/01/2005
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women aged 50 to 69 years
2. More than 12 months since last menses
3. Non-smokers (at least 12 months)
4. Sedentary: less than two hours per week of moderate sport activity (e.g. tennis, swimming, running, aerobics, fitness, volleyball) and not adherent to the international physical activity guideline. The international physical activity guideline states that every adult should accumulate 30 minutes or more of at least moderately intense physical activity for at least five days per week
4. Knowledge of the Dutch language
5. Agreement to be randomly assigned to either the exercise intervention or control group
6. Informed consent to participate in all screening and study activities
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
189
Participant exclusion criteria
1. Use of hormone replacement or oral contraceptives in past six months
2. Morbidly obese (Body Mass Index [BMI] more than 40)
3. BMI less than 22
4. Currently on or planning to go on a strict diet
5. Ever diagnosed with breast cancer
6. Diagnosis of other types of cancer in the past five years
7. Diabetes mellitus or other endocrine related diseases
8. Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
9. Alcohol or drug abuse
10. Maintenance use of corticosteroids
11. Use of beta blockers
Recruitment start date
01/01/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
Funders
Funder type
Charity
Funder name
Dutch Cancer Society (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 protocol on http://www.ncbi.nlm.nih.gov/pubmed/17767724
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19687339
Publication citations
-
Protocol
Monninkhof EM, Peeters PH, Schuit AJ, Design of the sex hormones and physical exercise (SHAPE) study., BMC Public Health, 2007, 7, 232, doi: 10.1186/1471-2458-7-232.
-
Results
Monninkhof EM, Velthuis MJ, Peeters PH, Twisk JW, Schuit AJ, Effect of exercise on postmenopausal sex hormone levels and role of body fat: a randomized controlled trial., J. Clin. Oncol., 2009, 27, 27, 4492-4499, doi: 10.1200/JCO.2008.19.7459.