Breast Cancer Clinical Trial
Official title:
Effect of Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue and Systemic Biomarkers of Breast Cancer Risk
Verified date | May 2017 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2018 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Five year predicted breast cancer risk of at least 1.66%. - Prior breast biopsy showing atypical ductal or lobular hyperplasia or lobular carcinoma in situ or ductal carcinoma in situ (DCIS). - Known breast cancer-1 and -2 mutations. - Breast density >50% as assessed by the conventional two-dimensional method. Exclusion Criteria: - Weight loss of 10 pounds in past six months. - History of fish allergy. - Oral contraceptives or hormone replacement therapy in the past 6 months. - Pregnancy or lactation in the last 12 months or planning to become pregnant in the next 12 months. - Current smoking. - Diagnosis of cancer except basal cell carcinoma of the skin or lobular carcinoma in situ or DCIS. - Diagnosis of type 1 or type 2 diabetes based on standard criteria, irrespective of treatment. - Recent stroke or cardiovascular event. - History of eating disorders documented in medical records. - History of major gastrointestinal disease impairing absorption. - History of bariatric surgery. - Recent, current or planned use of diet drugs as per patient history. - Participants must not use flaxseed oil supplements during study participation. - Participants must not use Omega-3 preparations while participating on this trial. - Participants must not use Tamoxifen or Raloxifene during study participation. |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ki67 expression | Ki67 expression by hyperplastic breast lesions | about 1 year |
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