Overview

This trial is active, not recruiting.

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
Treatments omega-3 fatty acid supplement, placebo, clinical assessments, assessment of therapy complications, magnetic resonance imaging, correlative/special studies
Sponsor Ohio State University Comprehensive Cancer Center
Collaborator Cancer and Leukemia Group B
Start date October 2011
End date January 2014
Trial size 40 participants
Trial identifier NCT01478477, NCI-2011-03262, OSU-11022

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
omega-3 fatty acid supplement fish oil
6 capsules per day (4.3 g)x 6 months
clinical assessments Brief Pain Inventory
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.
assessment of therapy complications adverse events
Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
magnetic resonance imaging MRI
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.
correlative/special studies laboratory 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.
(Placebo Comparator)
Typical American Diet oils (TAD)
placebo PLCB
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.
clinical assessments Brief Pain Inventory
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.
assessment of therapy complications adverse events
Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
magnetic resonance imaging MRI
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.
correlative/special studies laboratory 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.
(Experimental)
Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES)
omega-3 fatty acid supplement fish oil
6 capsules per day (4.3 g)x 6 months
placebo PLCB
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.
(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.
omega-3 fatty acid supplement fish oil
6 capsules per day (4.3 g)x 6 months
placebo PLCB
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.
(Experimental)
Optional bilateral hand and wrist MRI imaging will be obtained
omega-3 fatty acid supplement fish oil
6 capsules per day (4.3 g)x 6 months
placebo PLCB
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.
(Experimental)
Enrolled participants will have peripheral blood samples drawn for plasma and RBC n-3 PUFA levels within 4 weeks of starting AI therapy.
omega-3 fatty acid supplement fish oil
6 capsules per day (4.3 g)x 6 months
placebo PLCB
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.

Primary Outcomes

Measure
Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument
time frame: baseline, 6 months

Secondary Outcomes

Measure
Pain score change after 6 months (6 months -baseline) based on the HAS and BPI instruments
time frame: baseline, 6 months
Compliance rates with oral supplements (omega-3 fatty acid and placebo)
time frame: baseline, 6 months
Feasibility of using the instruments HAS, BPI-short, FACT-B/ES for the assessment of joint symptoms
time frame: baseline, 6 months
Effectiveness of blinding
time frame: baseline, 6 months
Correlation of guess with pain scores
time frame: baseline, 6 months
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study
Principal investigator Maryam Lustberg, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.