Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue

Withdrawn before enrolling · Early Phase 1 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01784042

Run by

Milton S. Hershey Medical Center

People needed

0

Starts

2013-03-01

Expected to finish

2018-03-01

Last updated by the study team

2017-05-09

Who can join

Age: 30 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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