Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (omega-3 fatty acid supplement)
Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
干预措施: omega-3 fatty acid supplement (Dietary Supplement)
Arm I (omega-3 fatty acid supplement)
Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
干预措施: Clinical assessments (Other)
Arm I (omega-3 fatty acid supplement)
Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
干预措施: Assessment of therapy complications (Other)
Arm I (omega-3 fatty acid supplement)
Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
干预措施: Magnetic Resonance Imaging (Procedure)
Arm I (omega-3 fatty acid supplement)
Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA)
干预措施: Correlative/special studies (Procedure)
Arm II (placebo)
Typical American Diet oils (TAD)
干预措施: Placebo (Other)
Arm II (placebo)
Typical American Diet oils (TAD)
干预措施: Assessment of therapy complications (Other)
Arm II (placebo)
Typical American Diet oils (TAD)
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (placebo)
Typical American Diet oils (TAD)
干预措施: Correlative/special studies (Procedure)
Arm II (placebo)
Typical American Diet oils (TAD)
干预措施: Clinical assessments (Other)
Clinical Assessments
Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES)
干预措施: omega-3 fatty acid supplement (Dietary Supplement)
Clinical Assessments
Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES)
干预措施: Placebo (Other)
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.
干预措施: omega-3 fatty acid supplement (Dietary Supplement)
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.
干预措施: Placebo (Other)
Magnetic Resonance Imaging
Optional bilateral hand and wrist MRI imaging will be obtained
干预措施: omega-3 fatty acid supplement (Dietary Supplement)
Magnetic Resonance Imaging
Optional bilateral hand and wrist MRI imaging will be obtained
干预措施: Placebo (Other)
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.
干预措施: omega-3 fatty acid supplement (Dietary Supplement)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument
时间窗: baseline, 6 months
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.
次要结局
- 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)
- Pain score change after 6 months (6 months -baseline) based on the HAS and BPI instruments(baseline, 6 months)
- Effectiveness of blinding(baseline, 6 months)
- Relationship between serum and RBC omega-3 fatty acid levels, inflammatory blood markers and MRI changes and the joint symptoms(baseline, 6 months)
- Correlation of guess with pain scores(baseline, 6 months)
研究者
Nicole Williams
Principal Investigator
Ohio State University Comprehensive Cancer Center