- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00359060
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
Studieoversikt
Detaljert beskrivelse
Physical activity has been associated with a decreased risk for breast cancer. The biological mechanism(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical activity prevents overweight and abdominal adiposity.
In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strength training exercise programme. Participants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globulin and insulin. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.
This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.
Studietype
Registrering
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Utrecht, Nederland, 3508 GA
- University Medical Center Utrecht, Julius Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Women aged 50 -69 year
- > 12 months since last menses
- Non-smokers (at least 12 months)
- Sedentary
- Knowledge of the Dutch language
- Agreement to be randomly assigned to either the exercise intervention or control group
- Informed consent to participate in all screening and study activities
Exclusion Criteria:
- Use of hormone replacement or oral contraceptives in past 6 months
- Morbidly obese (BMI > 40)
- BMI < 22
- Currently on or planning to go on a strict diet
- Ever diagnosed with breast cancer
- Diagnosis of other types of cancer in the past 5 years
- Diabetes mellitus or other endocrine related diseases
- Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
- Alcohol or drug abuse
- Maintenance use of corticosteroids
- Use of beta blockers
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Hva måler studien?
Primære resultatmål
Resultatmål |
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Insulinfølsomhet
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Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate
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Serum concentrations of endogenous androgens: testosterone, androstenedione
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Serum concentrations of sex hormone binding globulin
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Serum concentrations of fasting insulin
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Sekundære resultatmål
Resultatmål |
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Blodtrykk
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Vekt
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Kroppsmasseindeks (BMI)
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Medisinbruk
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Fysisk form
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Amount of total body fat and intra-abdominal fat
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Body fat distribution
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Waist to hip ratio
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Lifestyle parameters (covariates)
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Exercise behaviour (habitual physical activity, past week activity, physical activity in the past)
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Diet (daily caloric intake; percent daily calories from fat, carbohydrates and proteins)
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Alcohol consumption
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Reproductive factors
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Medical history
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jantine Schuit, PhD, Dutch Institute of Public Health and the Environment
- Hovedetterforsker: Petra HM Peeters, PhD, University Medical Center Utrecht, Julius Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UU 2003-2793
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