Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

NCT02831582 | Completed DMC

• 2 other identifiers: OSU-15222NCI-2016-00377
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.

Conditions

Arthralgia; Breast Neoplasms

Keywords

Breast Cancer; Postmenopausal; Stage IA; Stage IB; Stage IIA; Stage IIB; Stage IIIA; Stage IIIB; Stage IIIC

Outcome Measures

Primary Outcomes (1)

• Change in pain score based on the Brief Pain Inventory (BPI)

  Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.

  Baseline to up to 6 months

Secondary Outcomes (5)

• Change in joint symptoms based on quality of life instruments

  Baseline to up to 6 months

• Change in joint symptoms based on symptomatology instruments

  Baseline to up to 6 months

• Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias

  Up to 6 months

• Rate of compliance

  Up to 6 months

• SNP analysis by standard data preprocessing operations and sequential analysis

  Up to 6 months

Other Outcomes (2)

• Level of inflammatory markers

  Up to 6 months

• Red blood cells (RBC) n-3 PUFA levels

  Up to 6 months

Study Arms (2)

Arm I (omega-3 fatty acid)

ACTIVE COMPARATOR

Patients receive omega-3 fatty acid supplementation PO QD for 6 months.

Dietary Supplement: Omega-3 Fatty Acid

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD for 6 months.

Other: Placebo

Interventions

Omega-3 Fatty Acid DIETARY_SUPPLEMENT

Given PO.

Also known as: n-3 Fatty Acid, Omega 3 Fatty Acid, OMEGA-3 FATTY ACIDS, Omega-3 Polyunsaturated Fatty Acid, Omega-3 PUFA, omega-3-Fatty Acids

Arm I (omega-3 fatty acid)

Placebo OTHER

Given PO.

Also known as: placebo therapy, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole)
• Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed.
• Prior tamoxifen use is allowed
• Prior chemotherapy is allowed
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Metastatic malignancy of any kind
• Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
• AI use \> 21 days prior to study enrollment
• Known bleeding disorders
• Current use of warfarin or other anticoagulants
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if \> 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
• Pregnant or nursing women
• Known sensitivity or allergy to fish or fish oil
• Unable to give informed consent

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.

  PMID: 35005781 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Arthralgia; Breast Neoplasms

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nicole Williams, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: July 13, 2016
• Study Start: October 12, 2016
• Primary Completion: December 11, 2021
• Study Completion: December 11, 2021
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)