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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03262 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Cancer and Leukemia Group B | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (omega-3 fatty acid supplement) | Experimental | Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA) |
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| Arm II (placebo) | Placebo Comparator | Typical American Diet oils (TAD) |
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| Clinical Assessments | Experimental | Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES) |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 fatty acid supplement | Dietary Supplement | 6 capsules per day (4.3 g)x 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score change after 6 months (6 months -baseline) based on the HAS and BPI instruments | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Williams, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29233615 | Derived | 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. |
| Label | URL |
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| Jamesline | View source |
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| Magnetic Resonance Imaging |
| Experimental |
Optional bilateral hand and wrist MRI imaging will be obtained |
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| 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. |
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| 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. |
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| 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. |
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| Assessment of therapy complications | Other | Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). |
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| 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. |
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| 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. |
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| 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 | Summarized using a Chi-square test. | baseline, 6 months |
| Correlation of guess with pain scores | Checked using logistic models to see if treatment guesses are explained by the patient's awareness of clinical benefit. | baseline, 6 months |
| Relationship between serum and RBC omega-3 fatty acid levels, inflammatory blood markers and MRI changes and the joint symptoms | 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. | baseline, 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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