Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole

NCT01478477 | Completed DMC

• 2 other identifiers: OSU-11022NCI-2011-03262
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer.

Conditions

Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument

  Pain scores based on FACT-B/ES, HAS and BPI will be plotted over time for each arm. Agreement between HAS, BPI-short and FACT-B/ES evaluated using Altman and Bland plot after proper data transformation. Also, Linear Mixed model used to explore if the pain scores are different at 3 and 6 months. Logistic regression models used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups, with potential covariates including age, body mass index, baseline pain scores (0 month), prior chemotherapy and other variables.

  baseline, 6 months

Secondary Outcomes (6)

• Pain score change after 6 months (6 months -baseline) based on the HAS and BPI instruments

  baseline, 6 months

• Compliance rates with oral supplements (omega-3 fatty acid and placebo)

  baseline, 6 months

• Feasibility of using the instruments HAS, BPI-short, FACT-B/ES for the assessment of joint symptoms

  baseline, 6 months

• Effectiveness of blinding

  baseline, 6 months

• Correlation of guess with pain scores

  baseline, 6 months

Study Arms (6)

Arm I (omega-3 fatty acid supplement)

EXPERIMENTAL

Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)

Dietary Supplement: omega-3 fatty acid supplement; Other: Clinical assessments; Other: Assessment of therapy complications; Procedure: Magnetic Resonance Imaging; Procedure: Correlative/special studies

Arm II (placebo)

PLACEBO COMPARATOR

Typical American Diet oils (TAD)

Other: Placebo; Other: Clinical assessments; Other: Assessment of therapy complications; Procedure: Magnetic Resonance Imaging; Procedure: Correlative/special studies

Clinical Assessments

EXPERIMENTAL

Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES)

Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo

Assessment of therapy complications

EXPERIMENTAL

Adverse events will be monitored by self-reporting of signs and symptoms. Patients will maintain a daily diary of time of supplement intake and any possible ill effects, with instructions to contact the PI or Research Nurse to discuss and manage any possible side effects.

Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo

Magnetic Resonance Imaging

EXPERIMENTAL

Optional bilateral hand and wrist MRI imaging will be obtained

Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo

Correlative/special studies

EXPERIMENTAL

Enrolled participants will have peripheral blood samples drawn for plasma and RBC n-3 PUFA levels within 4 weeks of starting AI therapy.

Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo

Interventions

omega-3 fatty acid supplement DIETARY_SUPPLEMENT

6 capsules per day (4.3 g)x 6 months

Also known as: fish oil, omega fatty acid, O3FA, MNSG-194®, n-3 PUFA supplementation

Arm I (omega-3 fatty acid supplement); Assessment of therapy complications; Clinical Assessments; Correlative/special studies; Magnetic Resonance Imaging

Placebo OTHER

6 capsules per day (4.3 g)x 6 months. Supplement should be taken with food once per day. No specific food requirements are needed.

Also known as: PLCB, Typical American Diet oils, TAD

Arm II (placebo); Assessment of therapy complications; Clinical Assessments; Correlative/special studies; Magnetic Resonance Imaging

Clinical assessments OTHER

All three instruments will be administered at baseline, at 3 months, 6 months and at additional time intervals when there is a significant change in therapy (discontinuation/switch, pain medication administration) during routine medical oncology visits.

Also known as: Brief Pain Inventory, BPI, Stanford's Health Assessment-Disability Index, HAS, FACT-B and endocrine subscale, FACT-ES

Arm I (omega-3 fatty acid supplement); Arm II (placebo)

Assessment of therapy complications OTHER

Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).

Also known as: adverse events, toxicities, Expected Toxicities, Potential Toxicities

Arm I (omega-3 fatty acid supplement); Arm II (placebo)

Magnetic Resonance Imaging PROCEDURE

Optional bilateral hand and wrist MRI imaging will be obtained at baseline and at 6 months to eligible patients who have no contraindications to MRI imaging.

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Arm I (omega-3 fatty acid supplement); Arm II (placebo)

Correlative/special studies PROCEDURE

Plasma, RBC, and serum samples from the baseline blood draw will also be stored at -70C for fatty acid and biomarker analyses and repeated at 3 month and 6 month intervals. Samples will be analyzed in batches every 6 months.

Also known as: laboratory studies

Arm I (omega-3 fatty acid supplement); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with breast cancer stages I-III initiating first adjuvant AI therapy with any of the Food and Drug Administration- (FDA) approved AIs (anastrozole, 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
• History of osteoarthritis and/or fibromyalgia 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, with the exception of osteoarthritis and fibromyalgia
• AI use \> 2 weeks prior to study enrollment
• Known bleeding disorders
• History of diabetes mellitus, heart disease or TIA/stroke
• 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 regular or any other supplements that might interact with n-3 PUFA supplements within six months of study initiation; sporadic use of n-3 PUFA supplement may be eligible if there has been a 3-month washout period prior to randomization
• Pregnant or nursing women
• Known sensitivity or allergy to fish or fish oil
• Concurrent use of daily full dose aspirin (≥ 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month washout period is required prior to randomization
• Unable to give informed consent
• In patients consenting for optional MRIs, any contraindication to MRI examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Cancer and Leukemia Group B: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Orchard TS, Andridge RR, Yee LD, Lustberg MB. Diet Quality, Inflammation, and Quality of Life in Breast Cancer Survivors: A Cross-Sectional Analysis of Pilot Study Data. J Acad Nutr Diet. 2018 Apr;118(4):578-588.e1. doi: 10.1016/j.jand.2017.09.024. Epub 2017 Dec 9.

  PMID: 29233615 DERIVED

Related Links

• Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fish Oils; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Nicole Williams, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 23, 2011
• Study Start: October 4, 2011
• Primary Completion: January 9, 2014
• Study Completion: January 9, 2014
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)