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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00377 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (omega-3 fatty acid) | Active Comparator | Patients receive omega-3 fatty acid supplementation PO QD for 6 months. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO QD for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acid | Dietary Supplement | Given PO. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain score based on the Brief Pain Inventory (BPI) | Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models. | Baseline to up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in joint symptoms based on quality of life instruments | An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups. | Baseline to up to 6 months |
| Change in joint symptoms based on symptomatology instruments |
| Measure | Description | Time Frame |
|---|---|---|
| Level of inflammatory markers | Up to 6 months | |
| Red blood cells (RBC) n-3 PUFA levels | The relationship between RBC n-3 PUFA levels, inflammatory blood markers and the joint symptoms evaluated by the patient symptom assessment instruments. Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pairwise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Williams, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Cleveland Clinic Cancer Center/Fairview Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35005781 | Derived | 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. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| Placebo | Other | Given PO. |
|
|
An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups. |
| Baseline to up to 6 months |
| Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias | Interaction tests between treatment and stratification variables will be conducted to explore whether these factors are predictive of average pain scores. | Up to 6 months |
| Rate of compliance | The rates of adherence to and discontinuation of AI therapy will be recorded. Reasons for treatment discontinuation will be described. In addition, the investigators will also examine the compliance rates with n-3 PUFA or placebo supplements with pill counts at each visit and with a patient recorded medication calendar. | Up to 6 months |
| SNP analysis by standard data preprocessing operations and sequential analysis | A sequential analysis of the data that allows filtering of extraneous SNPs and select SNP loci, identification and creation of predictive SNP clusters, and then evaluation of the networks' potential clinical and biological validity will be performed. | Up to 6 months |
| Up to 6 months |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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