Status:
COMPLETED
Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Healthy, no Evidence of Disease
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
RATIONALE: Exercise may change the risk of developing breast cancer. It is not yet known whether low-intensity exercise or high-intensity exercise is more effective in lowering the risk of breast canc...
Detailed Description
OBJECTIVES: Primary * To conduct a dose response study of low- or high-dose exercise over 5 menstrual cycles, with no concomitant dietary changes producing a caloric deficit, in healthy younger wome...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Healthy women with ≥ 18% lifetime risk for breast cancer as evidenced by the following:
- Documentation from a genetic counselor of a known familial breast cancer susceptibility mutation
- Claus model risk of ≥18%
- Predicted probability of BRCA1/2 mutation \> 25% based on the Myriad model
- Documentation of a known mutation in a family member such that the Mendelian probability of a BRCA1/2 mutation would be \>25%
- History of lobular carcinoma in situ
- No prior prophylactic mastectomy
- Leisure-time exercise energy expenditure of ≤ 500 kcal/week over the past 6 months
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Premenopausal
- Menstrual cycles 25-32 days in length
- Intact ovaries and uterus
- Gynecologic age (defined as participant's current age minus the age at which she started menstruating) of at least 4 years
- Body mass index 21-50
- No history of menstrual difficulties
- No history of physician-diagnosed gynecological disease (e.g., fibroids, endometriosis, or polycystic ovary syndrome)
- Not pregnant
- Not planning to become pregnant during the study period
- No medical conditions or medications that would prohibit participation in aerobic exercise or would negatively impact the study
- No history of cancer, except nonmelanoma skin cancers, and in situ cervical cancers
- No eating disorders (e.g., bulimia or binge-eating disorder)
- At least one year since prior smoking
- Not planning to move away from the area during the period of the study
- No concurrent participation in any weight loss programs
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 months since prior hormonal contraception
- Must use effective non-hormonal contraception unless participant has undergone prior tubal ligation
- Consumes no more than 7 alcoholic beverages per week
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2016
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT00892515
Start Date
October 1 2008
End Date
May 20 2016
Last Update
April 16 2020
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283