Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer

NCT01869764 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: IRB00023419NCI-2013-00963P30CA012197CCCWFU 98113
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.

Conditions

Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ; Male Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (3)

• PUFA Levels in Normal and Metastatic Breast Tissue

  Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3

  At time of surgery

• PUFA Levels in Plasma Pre and Post Surgery

  Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3

  Pre and post surgery

• PUFA Levels in Red Blood Cells Pre and Post Surgery

  Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3

  Pre and post surgery

Secondary Outcomes (3)

• Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue

  At time of surgery

• Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue

  At time of surgery

• Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue

  At time of surgery

Study Arms (2)

Arm I (omega-3 fatty acid)

EXPERIMENTAL

Patients receive omega-3 fatty acid PO daily for 7-14 days.

Drug: omega-3 fatty acid; Other: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO daily for 7-14 days.

Other: placebo; Other: laboratory biomarker analysis

Interventions

omega-3 fatty acid DRUG

Given PO

Also known as: fish oil, n-3 fatty acid, O3FA

Arm I (omega-3 fatty acid)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (omega-3 fatty acid); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ \[LCIS\] and ductal carcinoma in situ \[DCIS\])
• Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
• Tumor measures at least 1 centimeter on imaging or physical exam

You may not qualify if:

• Any patient with surgery scheduled \< 7days after biopsy
• Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
• Patients who will receive neoadjuvant chemotherapy are not eligible
• Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
• Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
• Patients with an allergy or known hypersensitivity to fish

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms, Male; Breast Neoplasms

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Results Point of Contact

• Title: Edward Levine, MD
• Organization: Wake Forest University Health Sciences

elevine@wakehealth.edu

336-716-5440

Study Officials

• Edward Levine, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 5, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-10

Locations

US (1)