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

NCT01784042 | Withdrawn Early Phase 1 DMC

• 1 other identifier: PSHCI 12-075
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; omega-3 fatty acids

Outcome Measures

Primary Outcomes (1)

• Ki67 expression

  Ki67 expression by hyperplastic breast lesions

  about 1 year

Study Arms (4)

No dietary energy restriction plus Placebo

PLACEBO COMPARATOR

No dietary energy restriction plus Placebo

Drug: Placebo

Dietary energy restriction plus placebo

PLACEBO COMPARATOR

Dietary energy restriction plus placebo

Drug: Placebo; Other: Dietary energy restriction

Lovaza

EXPERIMENTAL

Lovaza only

Drug: Lovaza

Dietary energy restriction plus Lovaza

EXPERIMENTAL

Dietary energy restriction plus Lovaza

Drug: Lovaza; Other: Dietary energy restriction

Interventions

Placebo DRUG

placebo

Dietary energy restriction plus placebo; No dietary energy restriction plus Placebo

Lovaza DRUG

Also known as: Lovaza (omega-3-acid ethyl esters)

Dietary energy restriction plus Lovaza; Lovaza

Dietary energy restriction OTHER

Dietary energy restriction plus Lovaza; Dietary energy restriction plus placebo

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Omacor

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Manni, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Endocrinology, Diabetes and Metabolism

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

US (1)