Administration of omega-3 fatty acids and Raloxifene to women at high risk of breast cancer: Interim feasibility and biomarkers analysis from a clinical trial

C. Signori, C. Dubrock, John Richie, B. Prokopczyk, Laurence Demers, C. Hamilton, Terryl Johnson Hartman, Jiangang (Jason) Liao, Karam El-Bayoumy, Andrea Manni

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Background/Objectives:The antiestrogen, Raloxifene (Ral) is an effective breast cancer chemopreventive agent. Omega-3 fatty acids (n-3FA) may inhibit mammary carcinogenesis. On the basis of their mechanisms of action, we test the hypothesis that a combination of n-3FA and Ral may be superior in reducing select biomarkers of breast cancer risk in women.Subjects/Methods:Postmenopausal women at increased risk for breast cancer (breast density 25%) were randomized to: (1) no intervention; (2) Ral 60 mg; (3) Ral 30 mg; (4) n-3FA (Lovaza) 4 g and (5) Lovaza 4 gRal 30 mg for 2 years. Reduction in breast density is the primary end point of the study. We report preliminary data on feasibility, compliance and changes in secondary end points related to IGF-I signaling, estrogen metabolism, oxidative stress and inflammation in the first group of 46 women who completed 1 year of the study.Results:All interventions were well tolerated with excellent compliance (961% overall) by pill count and also supported by the expected rise in both serum n-3FA and n-3FA/Omega-6 fatty acids (n-6FA) ratio in women randomized to groups 4 and 5 (P0.05). Lovaza decreased serum triglycerides and increased high-density lipoprotein (HDL) cholesterol compared with control (P0.05 for both). Ral reduced serum IGF-1 in a dose-dependent manner (P0.05) while Lovaza did not. Lovaza had no effect on IGF-1 or IGFBP-3. None of the other biomarkers were affected by our treatment.Conclusion:The combination of Lovaza and Ral is a feasible strategy that may be recommended in future breast cancer chemoprevention trials.

Original languageEnglish (US)
Pages (from-to)878-884
Number of pages7
JournalEuropean Journal of Clinical Nutrition
Volume66
Issue number8
DOIs
StatePublished - Aug 1 2012

Fingerprint

Omega-3 Fatty Acids
Biomarkers
Clinical Trials
Breast Neoplasms
Insulin-Like Growth Factor I
Compliance
Serum
Omega-6 Fatty Acids
Insulin-Like Growth Factor Binding Protein 3
Estrogen Receptor Modulators
Chemoprevention
HDL Cholesterol
Omacor
Raloxifene Hydrochloride
Estrogens
Carcinogenesis
Triglycerides
Oxidative Stress
Breast
Inflammation

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

Cite this

@article{f585956bf2134779ba11445d9420d8fb,
title = "Administration of omega-3 fatty acids and Raloxifene to women at high risk of breast cancer: Interim feasibility and biomarkers analysis from a clinical trial",
abstract = "Background/Objectives:The antiestrogen, Raloxifene (Ral) is an effective breast cancer chemopreventive agent. Omega-3 fatty acids (n-3FA) may inhibit mammary carcinogenesis. On the basis of their mechanisms of action, we test the hypothesis that a combination of n-3FA and Ral may be superior in reducing select biomarkers of breast cancer risk in women.Subjects/Methods:Postmenopausal women at increased risk for breast cancer (breast density 25{\%}) were randomized to: (1) no intervention; (2) Ral 60 mg; (3) Ral 30 mg; (4) n-3FA (Lovaza) 4 g and (5) Lovaza 4 gRal 30 mg for 2 years. Reduction in breast density is the primary end point of the study. We report preliminary data on feasibility, compliance and changes in secondary end points related to IGF-I signaling, estrogen metabolism, oxidative stress and inflammation in the first group of 46 women who completed 1 year of the study.Results:All interventions were well tolerated with excellent compliance (961{\%} overall) by pill count and also supported by the expected rise in both serum n-3FA and n-3FA/Omega-6 fatty acids (n-6FA) ratio in women randomized to groups 4 and 5 (P0.05). Lovaza decreased serum triglycerides and increased high-density lipoprotein (HDL) cholesterol compared with control (P0.05 for both). Ral reduced serum IGF-1 in a dose-dependent manner (P0.05) while Lovaza did not. Lovaza had no effect on IGF-1 or IGFBP-3. None of the other biomarkers were affected by our treatment.Conclusion:The combination of Lovaza and Ral is a feasible strategy that may be recommended in future breast cancer chemoprevention trials.",
author = "C. Signori and C. Dubrock and John Richie and B. Prokopczyk and Laurence Demers and C. Hamilton and Hartman, {Terryl Johnson} and Liao, {Jiangang (Jason)} and Karam El-Bayoumy and Andrea Manni",
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Administration of omega-3 fatty acids and Raloxifene to women at high risk of breast cancer : Interim feasibility and biomarkers analysis from a clinical trial. / Signori, C.; Dubrock, C.; Richie, John; Prokopczyk, B.; Demers, Laurence; Hamilton, C.; Hartman, Terryl Johnson; Liao, Jiangang (Jason); El-Bayoumy, Karam; Manni, Andrea.

In: European Journal of Clinical Nutrition, Vol. 66, No. 8, 01.08.2012, p. 878-884.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Administration of omega-3 fatty acids and Raloxifene to women at high risk of breast cancer

T2 - Interim feasibility and biomarkers analysis from a clinical trial

AU - Signori, C.

AU - Dubrock, C.

AU - Richie, John

AU - Prokopczyk, B.

AU - Demers, Laurence

AU - Hamilton, C.

AU - Hartman, Terryl Johnson

AU - Liao, Jiangang (Jason)

AU - El-Bayoumy, Karam

AU - Manni, Andrea

PY - 2012/8/1

Y1 - 2012/8/1

N2 - Background/Objectives:The antiestrogen, Raloxifene (Ral) is an effective breast cancer chemopreventive agent. Omega-3 fatty acids (n-3FA) may inhibit mammary carcinogenesis. On the basis of their mechanisms of action, we test the hypothesis that a combination of n-3FA and Ral may be superior in reducing select biomarkers of breast cancer risk in women.Subjects/Methods:Postmenopausal women at increased risk for breast cancer (breast density 25%) were randomized to: (1) no intervention; (2) Ral 60 mg; (3) Ral 30 mg; (4) n-3FA (Lovaza) 4 g and (5) Lovaza 4 gRal 30 mg for 2 years. Reduction in breast density is the primary end point of the study. We report preliminary data on feasibility, compliance and changes in secondary end points related to IGF-I signaling, estrogen metabolism, oxidative stress and inflammation in the first group of 46 women who completed 1 year of the study.Results:All interventions were well tolerated with excellent compliance (961% overall) by pill count and also supported by the expected rise in both serum n-3FA and n-3FA/Omega-6 fatty acids (n-6FA) ratio in women randomized to groups 4 and 5 (P0.05). Lovaza decreased serum triglycerides and increased high-density lipoprotein (HDL) cholesterol compared with control (P0.05 for both). Ral reduced serum IGF-1 in a dose-dependent manner (P0.05) while Lovaza did not. Lovaza had no effect on IGF-1 or IGFBP-3. None of the other biomarkers were affected by our treatment.Conclusion:The combination of Lovaza and Ral is a feasible strategy that may be recommended in future breast cancer chemoprevention trials.

AB - Background/Objectives:The antiestrogen, Raloxifene (Ral) is an effective breast cancer chemopreventive agent. Omega-3 fatty acids (n-3FA) may inhibit mammary carcinogenesis. On the basis of their mechanisms of action, we test the hypothesis that a combination of n-3FA and Ral may be superior in reducing select biomarkers of breast cancer risk in women.Subjects/Methods:Postmenopausal women at increased risk for breast cancer (breast density 25%) were randomized to: (1) no intervention; (2) Ral 60 mg; (3) Ral 30 mg; (4) n-3FA (Lovaza) 4 g and (5) Lovaza 4 gRal 30 mg for 2 years. Reduction in breast density is the primary end point of the study. We report preliminary data on feasibility, compliance and changes in secondary end points related to IGF-I signaling, estrogen metabolism, oxidative stress and inflammation in the first group of 46 women who completed 1 year of the study.Results:All interventions were well tolerated with excellent compliance (961% overall) by pill count and also supported by the expected rise in both serum n-3FA and n-3FA/Omega-6 fatty acids (n-6FA) ratio in women randomized to groups 4 and 5 (P0.05). Lovaza decreased serum triglycerides and increased high-density lipoprotein (HDL) cholesterol compared with control (P0.05 for both). Ral reduced serum IGF-1 in a dose-dependent manner (P0.05) while Lovaza did not. Lovaza had no effect on IGF-1 or IGFBP-3. None of the other biomarkers were affected by our treatment.Conclusion:The combination of Lovaza and Ral is a feasible strategy that may be recommended in future breast cancer chemoprevention trials.

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