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

• Status: Withdrawn
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center

Criteria

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.