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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Maryam Lustberg, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01478477
First received: November 14, 2011
Last updated: August 2, 2013
Last verified: August 2013

November 14, 2011
August 2, 2013
October 2011
February 2015   (final data collection date for primary outcome measure)
Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01478477 on ClinicalTrials.gov Archive Site
  • Pain score change after 6 months (6 months -baseline) based on the HAS and BPI instruments [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    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.
  • Compliance rates with oral supplements (omega-3 fatty acid and placebo) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Feasibility of using the instruments HAS, BPI-short, FACT-B/ES for the assessment of joint symptoms [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Effectiveness of blinding [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Summarized using a Chi-square test.
  • Correlation of guess with pain scores [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Checked using logistic models to see if treatment guesses are explained by the patient's awareness of clinical benefit.
  • Relationship between serum and RBC omega-3 fatty acid levels, inflammatory blood markers and MRI changes and the joint symptoms [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pair wise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.
Same as current
Not Provided
Not Provided
 
Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole
Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study

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.

OBJECTIVES:

I. To assess the feasibility of evaluating joint symptoms in postmenopausal women with breast cancer randomized to n-3 PUFA (omega-3 fatty acid) vs. placebo supplementation using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale (FACT-ES), Brief Pain Inventory (BPI) and Stanford's Health Assessment -Disability Index (HAS) during the first 6 months of adjuvant aromatase inhibitor (AI) therapy.

II. To preliminarily evaluate the efficacy of n-3 PUFA vs. placebo supplementation on AI induced joint symptoms.

III. To explore blood and imaging based biomarkers (plasma and red blood cell [RBC] levels of n-3 PUFAs, inflammatory cytokines and receptors, and intra-articular tenosynovial inflammation by musculoskeletal magnetic resonance imaging [MRI] imaging) of AI-induced joint symptoms in women on AI therapy randomized to n-3 PUFAs vs. placebo supplementation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • 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
  • Dietary Supplement: omega-3 fatty acid supplement
    6 capsules per day (4.3 g)x 6 months
    Other Names:
    • fish oil
    • omega fatty acid
    • O3FA
    • MNSG-194®
    • n-3 PUFA supplementation
  • Other: Placebo
    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.
    Other Names:
    • PLCB
    • Typical American Diet oils
    • TAD
  • Other: Clinical assessments
    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.
    Other Names:
    • Brief Pain Inventory
    • BPI
    • Stanford's Health Assessment-Disability Index
    • HAS
    • FACT-B and endocrine subscale
    • FACT-ES
  • Other: Assessment of therapy complications
    Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
    Other Names:
    • adverse events
    • toxicities
    • Expected Toxicities
    • Potential Toxicities
  • Procedure: Magnetic Resonance Imaging
    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.
    Other Names:
    • MRI
    • NMR imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Procedure: Correlative/special studies
    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.
    Other Name: laboratory studies
  • Experimental: Arm I (omega-3 fatty acid supplement)
    Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
    Interventions:
    • Dietary Supplement: omega-3 fatty acid supplement
    • Other: Clinical assessments
    • Other: Assessment of therapy complications
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Correlative/special studies
  • Placebo Comparator: Arm II (placebo)
    Typical American Diet oils (TAD)
    Interventions:
    • Other: Placebo
    • Other: Clinical assessments
    • Other: Assessment of therapy complications
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Correlative/special studies
  • Experimental: Clinical Assessments
    Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES)
    Interventions:
    • Dietary Supplement: omega-3 fatty acid supplement
    • Other: Placebo
  • Experimental: Assessment of therapy complications
    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.
    Interventions:
    • Dietary Supplement: omega-3 fatty acid supplement
    • Other: Placebo
  • Experimental: Magnetic Resonance Imaging
    Optional bilateral hand and wrist MRI imaging will be obtained
    Interventions:
    • Dietary Supplement: omega-3 fatty acid supplement
    • Other: Placebo
  • Experimental: Correlative/special studies
    Enrolled participants will have peripheral blood samples drawn for plasma and RBC n-3 PUFA levels within 4 weeks of starting AI therapy.
    Interventions:
    • Dietary Supplement: omega-3 fatty acid supplement
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01478477
OSU-11022, NCI-2011-03262
Yes
Maryam Lustberg, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Cancer and Leukemia Group B
Principal Investigator: Maryam Lustberg, MD Ohio State University
Ohio State University Comprehensive Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP