Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors

NCT01849250 | Completed Phase 2 Results DMC

• 14 other identifiers: NCI-2013-0085912-47412-267N01-CN-2012-00034DFCI:12- 474AAAK6752MSKCC-12-267H-33017CUMC: AAAK67522011-0766MDA10-16-01N01CN00034N01CN35159P30CA016672
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

Brief Summary

This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.

Conditions

Benign Breast Neoplasm; Ductal Breast Carcinoma In Situ; Invasive Breast Carcinoma; Lobular Breast Carcinoma In Situ; Paget Disease of the Breast; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Normal Breast Tissue Expression of Tumor Necrosis Factor Alpha (TNF-alpha) Levels

  Differences in normal breast tissue levels of TNF-α 12 weeks post-treatment relative to pre-treatment for active treatment and placebo arm, compared using analysis of covariance where the post-treatment measurements were used as a dependent variable and the pretreatment measurements were included as a covariate in the analysis. For the primary study end-point TNF-α levels will be measured by quantitative real-time PCR (mRNA essays) on extracted RNA from breast core biopsies. Relative expression determined using the Computed Tomography (ΔΔCT) analysis protocol.

  Baseline to 12 weeks

Secondary Outcomes (6)

• Number of Participants With Crown-like Structures of the Breast (CLS-B) at Baseline and Post-treatment

  Baseline to 12 weeks

• Absolute Change in CLS-B/cm^2 Adjusted for the Pre-treatment Measurements

  Baseline to 12 weeks

• Breast Tissue Cox 2 mRNA Levels at Baseline and 12 Weeks

  Baseline to 12 weeks

• Mean Difference in the Breast Tissue IL- Beta mRNA Levels of Tissue Biomarkers

  Baseline to 12 weeks

• Mean Difference in the Breast Tissue Aromatase mRNA Levels of Tissue Biomarkers

  Baseline and 12 weeks

Study Arms (2)

Arm I (Docosahexaenoic Acid)

EXPERIMENTAL

Docosahexaenoic Acid orally twice a day (PO BID) for 12 weeks.

Drug: Docosahexaenoic Acid

Arm II (placebo)

PLACEBO COMPARATOR

Placebo orally twice a day (PO BID) for 12 weeks.

Other: Placebo

Interventions

Docosahexaenoic Acid DRUG

Given PO

Also known as: Fatty Acid 22:6

Arm I (Docosahexaenoic Acid)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

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

You may qualify if:

• Participants must have a history of histologically-confirmed stage I-III invasive breast cancer or ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease
• No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator
• \>= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy)
• Participants must have a body mass index (BMI) \>= 25, defined as (weight in kilograms/\[height in meters\]\^2)
• Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of prior pre-invasive breast cancer or benign biopsy of this breast will be permitted
• Daily DHA consumption =\< 200 mg/day in the month prior to screening estimated by an abbreviated DHA food frequency questionnaire
• Mammogram within no more than 6 months prior to the date of informed consent (normal/benign Breast Imaging-Reporting and Data System \[BI-RADS\] 1 or 2) and no further routine breast imaging planned during the course of the study (12 weeks DHA/placebo)
• Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%)
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 75,000/uL
• White blood cells \>= 3,000/uL
• Hemoglobin \>= 10 g/dL
• Total bilirubin within 1.5 times the institution's upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) within 1.5 times the institution's ULN
• Serum creatinine within 1.5 times the institution's ULN

You may not qualify if:

• Any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months
• A history of histologically-confirmed bilateral invasive breast cancer
• Bilateral mastectomy
• Prior history or evidence of metastatic breast cancer
• Prior radiation therapy to the contralateral (unaffected) breast
• Prior history of contralateral (unaffected) breast augmentation with breast implant placement
• History of daily use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in the week preceding study entry
• History of DHA supplementation \> 200 mg/day in the month preceding study entry
• History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators
• History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year
• Participants may not be receiving any other investigational agents during the study
• Women who have received cancer surgery, chemotherapy, biological therapy (e.g., trastuzumab), or radiotherapy for the treatment of any cancer within 6 months of study participation
• Women who are receiving endocrine therapy for breast cancer treatment or chemoprevention including tamoxifen, letrozole, anastrozole, fulvestrant, or exemestane at the time of screening
• Individuals with severe underlying chronic illness, such as uncontrolled diabetes; ongoing or active infection, psychiatric illness or social situations which in the opinion of the investigator would interfere with study participation
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to DHA or corn/soy oil in placebo agent

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Columbia University/Herbert Irving Cancer Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Paget's Disease, Mammary; Breast Neoplasms

Interventions

Docosahexaenoic Acids

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)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Powel H. Brown, MD/Chair, Clinical Cancer Prevention
• Organization: The University of Texas MD Anderson Cancer Center

PHBrown@mdanderson.org

713-792-7734

Study Officials

• Ayca Gucalp

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Powel H. Brown, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: January 11, 2016
• Study Completion: April 22, 2020
• Last Updated: December 28, 2021
• Results First Posted: December 28, 2021

Record last verified: 2021-12

Locations

US (4)