Influence of obesity on breast density reduction by omega-3 fatty acids: Evidence from a randomized clinical trial

Narinder Sandhu, Susann E. Schetter, Jason Liao, Terryl J. Hartman, John P. Richie, John McGinley, Henry J. Thompson, Bogdan Prokopczyk, Cynthia DuBrock, Carina Signori, Christopher Hamilton, Ana Calcagnotto, Neil Trushin, Cesar Aliaga, Laurence M. Demers, Karam El-Bayoumy, Andrea Manni

Research output: Contribution to journalArticle

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Abstract

Preclinical data indicate that omega-3 fatty acids (n-3FA) potentiate the chemopreventive effect of the antiestrogen (AE) tamoxifen against mammary carcinogenesis. The role of n-3FA in breast cancer prevention in humans is controversial. Preclinical and epidemiologic data suggest that n-3FA may be preferentially protective in obese subjects. To directly test the protective effect of n-3FA against breast cancer, we conducted a 2-year, open-label randomized clinical trial in 266 healthy postmenopausal women (50% normal weight, 30% overweight, 20% obese) with high breast density (BD; ≥25%) detected on their routine screening mammograms. Eligiblewomenwere randomized to one of the following five groups (i) no treatment, control; (ii) raloxifene 60 mg; (iii) raloxifene 30 mg; (iv) n-3FA lovaza 4 g; and (v) lovaza 4 g plus raloxifene 30 mg. The 2-year change in BD, a validated biomarker of breast cancer risk, was the primary endpoint of the study. In subset analysis, we tested the prespecified hypothesis that body mass index (BMI) influences the relationship between plasma n-3FA on BD. While none of the interventions affected BD in the intention-to-treat analysis, increase in plasma DHA was associated with a decrease in absolute breast density but only in participants with BMI >29. Our results suggest that obese women may preferentially experience breast cancer risk reduction from n-3FA administration.

Original languageEnglish (US)
Pages (from-to)275-282
Number of pages8
JournalCancer Prevention Research
Volume9
Issue number4
DOIs
StatePublished - Apr 2016

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Omega-3 Fatty Acids
Randomized Controlled Trials
Obesity
Breast Neoplasms
Body Mass Index
Intention to Treat Analysis
Estrogen Receptor Modulators
Tamoxifen
Risk Reduction Behavior
Carcinogenesis
Breast
Biomarkers
Weights and Measures
Breast Density
Raloxifene Hydrochloride
Omacor
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Sandhu, Narinder ; Schetter, Susann E. ; Liao, Jason ; Hartman, Terryl J. ; Richie, John P. ; McGinley, John ; Thompson, Henry J. ; Prokopczyk, Bogdan ; DuBrock, Cynthia ; Signori, Carina ; Hamilton, Christopher ; Calcagnotto, Ana ; Trushin, Neil ; Aliaga, Cesar ; Demers, Laurence M. ; El-Bayoumy, Karam ; Manni, Andrea. / Influence of obesity on breast density reduction by omega-3 fatty acids : Evidence from a randomized clinical trial. In: Cancer Prevention Research. 2016 ; Vol. 9, No. 4. pp. 275-282.
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abstract = "Preclinical data indicate that omega-3 fatty acids (n-3FA) potentiate the chemopreventive effect of the antiestrogen (AE) tamoxifen against mammary carcinogenesis. The role of n-3FA in breast cancer prevention in humans is controversial. Preclinical and epidemiologic data suggest that n-3FA may be preferentially protective in obese subjects. To directly test the protective effect of n-3FA against breast cancer, we conducted a 2-year, open-label randomized clinical trial in 266 healthy postmenopausal women (50{\%} normal weight, 30{\%} overweight, 20{\%} obese) with high breast density (BD; ≥25{\%}) detected on their routine screening mammograms. Eligiblewomenwere randomized to one of the following five groups (i) no treatment, control; (ii) raloxifene 60 mg; (iii) raloxifene 30 mg; (iv) n-3FA lovaza 4 g; and (v) lovaza 4 g plus raloxifene 30 mg. The 2-year change in BD, a validated biomarker of breast cancer risk, was the primary endpoint of the study. In subset analysis, we tested the prespecified hypothesis that body mass index (BMI) influences the relationship between plasma n-3FA on BD. While none of the interventions affected BD in the intention-to-treat analysis, increase in plasma DHA was associated with a decrease in absolute breast density but only in participants with BMI >29. Our results suggest that obese women may preferentially experience breast cancer risk reduction from n-3FA administration.",
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Sandhu, N, Schetter, SE, Liao, J, Hartman, TJ, Richie, JP, McGinley, J, Thompson, HJ, Prokopczyk, B, DuBrock, C, Signori, C, Hamilton, C, Calcagnotto, A, Trushin, N, Aliaga, C, Demers, LM, El-Bayoumy, K & Manni, A 2016, 'Influence of obesity on breast density reduction by omega-3 fatty acids: Evidence from a randomized clinical trial', Cancer Prevention Research, vol. 9, no. 4, pp. 275-282. https://doi.org/10.1158/1940-6207.CAPR-15-0235

Influence of obesity on breast density reduction by omega-3 fatty acids : Evidence from a randomized clinical trial. / Sandhu, Narinder; Schetter, Susann E.; Liao, Jason; Hartman, Terryl J.; Richie, John P.; McGinley, John; Thompson, Henry J.; Prokopczyk, Bogdan; DuBrock, Cynthia; Signori, Carina; Hamilton, Christopher; Calcagnotto, Ana; Trushin, Neil; Aliaga, Cesar; Demers, Laurence M.; El-Bayoumy, Karam; Manni, Andrea.

In: Cancer Prevention Research, Vol. 9, No. 4, 04.2016, p. 275-282.

Research output: Contribution to journalArticle

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T1 - Influence of obesity on breast density reduction by omega-3 fatty acids

T2 - Evidence from a randomized clinical trial

AU - Sandhu, Narinder

AU - Schetter, Susann E.

AU - Liao, Jason

AU - Hartman, Terryl J.

AU - Richie, John P.

AU - McGinley, John

AU - Thompson, Henry J.

AU - Prokopczyk, Bogdan

AU - DuBrock, Cynthia

AU - Signori, Carina

AU - Hamilton, Christopher

AU - Calcagnotto, Ana

AU - Trushin, Neil

AU - Aliaga, Cesar

AU - Demers, Laurence M.

AU - El-Bayoumy, Karam

AU - Manni, Andrea

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N2 - Preclinical data indicate that omega-3 fatty acids (n-3FA) potentiate the chemopreventive effect of the antiestrogen (AE) tamoxifen against mammary carcinogenesis. The role of n-3FA in breast cancer prevention in humans is controversial. Preclinical and epidemiologic data suggest that n-3FA may be preferentially protective in obese subjects. To directly test the protective effect of n-3FA against breast cancer, we conducted a 2-year, open-label randomized clinical trial in 266 healthy postmenopausal women (50% normal weight, 30% overweight, 20% obese) with high breast density (BD; ≥25%) detected on their routine screening mammograms. Eligiblewomenwere randomized to one of the following five groups (i) no treatment, control; (ii) raloxifene 60 mg; (iii) raloxifene 30 mg; (iv) n-3FA lovaza 4 g; and (v) lovaza 4 g plus raloxifene 30 mg. The 2-year change in BD, a validated biomarker of breast cancer risk, was the primary endpoint of the study. In subset analysis, we tested the prespecified hypothesis that body mass index (BMI) influences the relationship between plasma n-3FA on BD. While none of the interventions affected BD in the intention-to-treat analysis, increase in plasma DHA was associated with a decrease in absolute breast density but only in participants with BMI >29. Our results suggest that obese women may preferentially experience breast cancer risk reduction from n-3FA administration.

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