Clinical trial NCT02831582: Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
Official title: Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthralgia
Breast Neoplasms
Keywords: Breast Cancer
Postmenopausal
Stage IA
Stage IB
Stage IIA
Stage IIB
Stage IIIA
Stage IIIB
Stage IIIC
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in pain score based on the Brief Pain Inventory (BPI)
timeFrame: Baseline to up to 6 months
Secondary outcomes:
measure: Change in joint symptoms based on quality of life instruments
timeFrame: Baseline to up to 6 months
measure: Change in joint symptoms based on symptomatology instruments
timeFrame: Baseline to up to 6 months
measure: Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias
timeFrame: Up to 6 months
measure: Rate of compliance
timeFrame: Up to 6 months
measure: SNP analysis by standard data preprocessing operations and sequential analysis
timeFrame: Up to 6 months
Other outcomes:
measure: Level of inflammatory markers
timeFrame: Up to 6 months
measure: Red blood cells (RBC) n-3 PUFA levels
timeFrame: Up to 6 months
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center/Fairview Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Nicole Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.