Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer

NCT00892515 | Completed DMC

• 3 other identifiers: CDR0000617105UPCC-807822UPCC-09108
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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 cancer. PURPOSE: This randomized clinical trial is studying how well exercise programs work in healthy young women at increased risk of developing breast cancer.

Conditions

Breast Cancer; Healthy, no Evidence of Disease

Keywords

breast cancer; healthy, no evidence of disease

Outcome Measures

Primary Outcomes (1)

• Change in the area under the curve for urinary estrogen (E1G-AUC) adjusted for cycle length

Secondary Outcomes (4)

• Effects of exercise on variables known to affect or reflect mitogenic activity as related to breast cancer risk

• Changes in other physiologic parameters associated with breast mitotic activity

• Extent to which changes in body composition and body mass mediate observed changes in E1G-AUC

• Relationship between estrogen and progesterone from daily urinary measurements with observed menstrual cycle alterations (i.e., follicular and luteal phase length changes, and ovulatory status)

Study Arms (1)

exercise

EXPERIMENTAL

Behavioral: exercise intervention; Other: counseling intervention; Other: gas chromatography; Other: immunoenzyme technique; Other: immunologic technique; Other: laboratory biomarker analysis; Other: mass spectrometry; Other: physiologic testing; Other: questionnaire administration; Other: survey administration; Procedure: dual x-ray absorptometry; Procedure: magnetic resonance imaging; Procedure: study of high risk factors

Interventions

exercise intervention BEHAVIORAL

exercise

counseling intervention OTHER

exercise

gas chromatography OTHER

exercise

immunoenzyme technique OTHER

exercise

immunologic technique OTHER

exercise

laboratory biomarker analysis OTHER

exercise

mass spectrometry OTHER

exercise

physiologic testing OTHER

exercise

questionnaire administration OTHER

exercise

survey administration OTHER

exercise

dual x-ray absorptometry PROCEDURE

exercise

magnetic resonance imaging PROCEDURE

exercise

study of high risk factors PROCEDURE

exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Publications (1)

• Boyer AL, Arikawa AY, Schmitz KH, Sturgeon KM. Association of Inflammatory Diets with Inflammatory Biomarkers in Women at High Genetic Risk for Breast Cancer. Nutr Cancer. 2022;74(3):816-819. doi: 10.1080/01635581.2021.1986554. Epub 2021 Oct 6.

  PMID: 34615429 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Counseling; Chromatography, Gas; Immunoenzyme Techniques; Immunologic Techniques; Mass Spectrometry; Absorptiometry, Photon; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques; Immunoassay; Immunohistochemistry; Molecular Probe Techniques; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Spectrum Analysis

Study Officials

• Katie Schmitz, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 4, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 20, 2016
• Last Updated: April 16, 2020

Record last verified: 2020-04

Locations

US (1)