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

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ClinicalTrials.gov Identifier: NCT02831582
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Raquel Reinbolt, 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.

Condition or disease Intervention/treatment Phase
Arthralgia Breast Neoplasms Dietary Supplement: Omega-3 Fatty Acid Other: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid supplementation PO QD for 6 months.
Dietary Supplement: Omega-3 Fatty Acid
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 Comparator: Arm II (placebo)
Patients receive placebo PO QD for 6 months.
Other: Placebo
Given PO.
Other Names:
  • placebo therapy
  • sham therapy



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831582


Contacts
Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 Jamesline@osumc.edu

Locations
United States, Ohio
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alberto J. Montero, MD    216-445-1400    montero2@ccf.org   
Principal Investigator: Alberto J. Montero, MD         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Raquel E. Reinbolt, MD    614-293-0066    raquel.reinbolt@osumc.edu   
Contact: Lynette Mesi    614-293-6669    Lynette.Mesi@osumc.edu   
Principal Investigator: Raquel E. Reinbolt, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Raquel Reinbolt, MD Ohio State University Comprehensive Cancer Center

Additional Information:
Responsible Party: Raquel Reinbolt, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02831582     History of Changes
Other Study ID Numbers: OSU-15222
NCI-2016-00377 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Raquel Reinbolt, Ohio State University Comprehensive Cancer Center:
Breast Cancer
Postmenopausal
Stage IA
Stage IB
Stage IIA
Stage IIB
Stage IIIA
Stage IIIB
Stage IIIC

Additional relevant MeSH terms:
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs