Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02831582|
Recruitment Status : Suspended (protocol amendment pending)
First Posted : July 13, 2016
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arthralgia Breast Neoplasms||Dietary Supplement: Omega-3 Fatty Acid Other: Placebo||Phase 2|
I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation|
|Actual Study Start Date :||October 12, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid supplementation PO QD for 6 months.
Dietary Supplement: Omega-3 Fatty Acid
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for 6 months.
- Change in pain score based on the Brief Pain Inventory (BPI) [ Time Frame: Baseline to up to 6 months ]Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.
- Change in joint symptoms based on quality of life instruments [ Time Frame: Baseline to up to 6 months ]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.
- Change in joint symptoms based on symptomatology instruments [ Time Frame: Baseline to up to 6 months ]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.
- Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias [ Time Frame: Up to 6 months ]Interaction tests between treatment and stratification variables will be conducted to explore whether these factors are predictive of average pain scores.
- Rate of compliance [ Time Frame: Up to 6 months ]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.
- SNP analysis by standard data preprocessing operations and sequential analysis [ Time Frame: Up to 6 months ]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.
- Level of inflammatory markers [ Time Frame: Up to 6 months ]
- Red blood cells (RBC) n-3 PUFA levels [ Time Frame: Up to 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831582
|United States, Ohio|
|Cleveland Clinic Cancer Center/Fairview Hospital|
|Cleveland, Ohio, United States, 44195|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Maryam Lustberg, MD||Ohio State University Comprehensive Cancer Center|