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

Not Applicable

Completed

• Conditions: Breast Neoplasms; Arthralgia
• Interventions: Dietary Supplement: Omega-3 Fatty Acid; Other: Placebo

• Registration Number: NCT02831582
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs).

SECONDARY OBJECTIVES:

I. To prospectively define the population most at risk for developing AIIAs by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (SNP)/gene profile predictive of treatment intervention response.

OUTLINE: Patients are randomized to 1 of 2 groups.

Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for 6 months.

Group II: Patients receive placebo PO QD for 6 months.

After completion of study, patients will be followed up periodically.

Study Timeline

• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Study Start: 2016-10-12
• Primary Completion: 2021-12-11
• Study Completion: 2021-12-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (omega-3 fatty acid)	Omega-3 Fatty Acid	Patients receive omega-3 fatty acid supplementation PO QD for 6 months.
Arm II (placebo)	Placebo	Patients receive placebo PO QD for 6 months.

Primary Outcome Measures

Name	Time	Method
Change in pain score based on the Brief Pain Inventory (BPI)	Baseline to up to 6 months	Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.

Secondary Outcome Measures

Name	Time	Method
Change in joint symptoms based on quality of life instruments	Baseline to up to 6 months	An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups.
Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias	Up to 6 months	Interaction tests between treatment and stratification variables will be conducted to explore whether these factors are predictive of average pain scores.
Rate of compliance	Up to 6 months	The rates of adherence to and discontinuation of AI therapy will be recorded. Reasons for treatment discontinuation will be described. In addition, the investigators will also examine the compliance rates with n-3 PUFA or placebo supplements with pill counts at each visit and with a patient recorded medication calendar.
Change in joint symptoms based on symptomatology instruments	Baseline to up to 6 months	An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups.
SNP analysis by standard data preprocessing operations and sequential analysis	Up to 6 months	A sequential analysis of the data that allows filtering of extraneous SNPs and select SNP loci, identification and creation of predictive SNP clusters, and then evaluation of the networks' potential clinical and biological validity will be performed.

Trial Locations

Locations (3)

Cleveland Clinic Cancer Center/Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States

City of Hope; 🇺🇸 Duarte, California, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States