Condition category
Cancer
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands)

Sponsor details

P.O. Box 75508
Amsterdam
1070 AM
Netherlands

Sponsor type

Charity

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes