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NCT Number: NCT02831582

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acid

Dietary Supplement

Given PO.

Other names: n-3 Fatty Acid, Omega 3 Fatty Acid, OMEGA-3 FATTY ACIDS, Omega-3 Polyunsaturated Fatty Acid, Omega-3 PUFA, omega-3-Fatty Acids

Placebo

Other

Given PO.

Other names: placebo therapy, sham therapy

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in joint symptoms based on quality of life instruments

    Time frame: 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.

  2. Change in joint symptoms based on symptomatology instruments

    Time frame: 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.

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

    Time frame: 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.

  4. Rate of compliance

    Time frame: 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.

  5. SNP analysis by standard data preprocessing operations and sequential analysis

    Time frame: 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.

Other outcomes

  1. Level of inflammatory markers

    Time frame: Up to 6 months

  2. Red blood cells (RBC) n-3 PUFA levels

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2016
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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