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

Breast Neoplasms Clinical Trial

Official title:

Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831582
• Other study ID #: OSU-15222
• Secondary ID: NCI-2016-00377
• Status: Completed
• Phase: N/A
• Start date: October 12, 2016
• Est. completion date: December 11, 2021

Study information

• Verified date: February 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 11, 2021
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Breast Neoplasms

Intervention

Dietary Supplement:
• Omega-3 Fatty Acid
Given PO.

Other:
• Placebo
Given PO.

Locations

Country	Name	City	State
United States	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of inflammatory markers		Up to 6 months
Other	Red blood cells (RBC) n-3 PUFA levels	The relationship between RBC n-3 PUFA levels, inflammatory blood markers and the joint symptoms evaluated by the patient symptom assessment instruments. Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pairwise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.	Up to 6 months
Primary	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	Change in joint symptoms based on quality of life instruments	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.	Baseline to up to 6 months
Secondary	Change in joint symptoms based on symptomatology instruments	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.	Baseline to up to 6 months
Secondary	Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias	Interaction tests between treatment and stratification variables will be conducted to explore whether these factors are predictive of average pain scores.	Up to 6 months
Secondary	Rate of compliance	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.	Up to 6 months
Secondary	SNP analysis by standard data preprocessing operations and sequential analysis	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.	Up to 6 months

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