Altering Lipids for Tolerance of Aromatase Inhibitor Therapy
Keywords
Abstract
Dates
Last Verified: | 05/31/2020 |
First Submitted: | 01/28/2020 |
Estimated Enrollment Submitted: | 02/09/2020 |
First Posted: | 02/12/2020 |
Last Update Submitted: | 06/09/2020 |
Last Update Posted: | 06/10/2020 |
Actual Study Start Date: | 07/31/2020 |
Estimated Primary Completion Date: | 01/31/2023 |
Estimated Study Completion Date: | 04/30/2023 |
Condition or disease
Intervention/treatment
Dietary Supplement: Omega 3 fatty acid supplement
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Omega 3 fatty acid supplement Omega-3 ethyl esters orally daily (containing 465 mg eicosapentaenoic acid [EPA] and 375 mg docosahexaenoic acid [DHA] per capsule,supplied as 4 x 1gm capsule) | Dietary Supplement: Omega 3 fatty acid supplement 4 capsules taken by mouth each day for 24 weeks (starting at the week 12 visit). |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Female |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria - Female subject aged ≥ 18 years who are postmenopausal according to standard clinical criteria or who will have been receiving LHRH agonist therapy for at least 28 days prior to AI initiation. - Stage 0-3 estrogen receptor positive (≥1%) and/or progesterone receptor positive (≥1%) breast cancer. - Planned initiation of aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention up to 30 days following baseline visit (ok to initiate screening up to 2 months before planned baseline visit). Concurrent LHRH agonist, anti-HER2 directed therapy (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine), and/or CDK4/6 inhibitor therapy (e.g., palbociclib, ribociclib, abemaciclib) is permitted. Prior tamoxifen and/or toremifene is permitted. - Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer. Completion of axillary surgery as indicated (not required). - Completion of chemotherapy, if indicated. Concurrent use of radiation therapy, LHRHa therapy, anti-HER2 therapy, and CDK4/6 inhibitor therapy is permitted. Prior tamoxifen is permitted. - Agree to avoid taking omega-3 fatty acid supplements from sources outside the trial during study participation. - ECOG Performance Status ≤ 3. - Able to complete questionnaires in English. - Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria - Prior use of AI therapy for treatment or prevention of breast cancer. - Use of omega-3 fatty acid supplementation during the 3 months prior to enrollment. Consumption of O3-FA through diet is permitted. - Use of warfarin, enoxaparin, or direct oral anticoagulants within 7 days prior to registration. - Known chronic liver disease (laboratory studies will not be assessed). Patients with hepatosteatosis, viral hepatitis, or other liver disorders who have adequate liver function according to the treating physician are permitted to enroll. - Known symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (EKGs will not be performed). - History of pancreatitis. - Hypersensitivity to fish and/or shellfish. - Unable to take oral medications. - Any medical condition that would interfere with the absorption of study medication capsules. - Patients with a prior or concurrent malignancy whose natural history or treatment does not, in the opinion of the treating investigator, have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. |
Outcome
Primary Outcome Measures
1. Change in percentage of total fatty acids for each polyunsaturated fatty acid (PUFA) group from start of Omega-3 Fatty Acid (O3-FA) supplementation to 3 months of O3-FA [From start of Omega-3 Fatty Acid (O3-FA) supplementation to 3 months of O3-FA (at 6 months after start of AI therapy)]
Secondary Outcome Measures
1. Change in percentage of total fatty acids for each PUFA group from baseline to 6 months of Aromatase Inhibitor (AI) (3 months of AI alone + 3 months of AI with O3-FA supplementation) [At 6 months after start of AI therapy]
2. Change in percentage of total fatty acids for each PUFA group from baseline to 3 months of AI therapy alone [At 3 months after start of AI therapy]
3. Number of participants who develop AI-associated musculoskeletal symptoms (AIMSS) [Up to 9 months after start of AI therapy]
4. Number of participants that discontinue AI therapy due to AIMSS [Up to 9 months after start of AI therapy]
5. Number of participants that discontinue AI therapy due to toxicity. [Up to 9 months after start of AI therapy]