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N/A N=266 Randomized Prevention

Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

Breast Cancer

Enrolled (actual)
266
Serious AEs
0.4%
Results posted
Nov 2018
Primary outcome: Primary: Change in Absolute Breast Density — 65.53; 64.39; 65.08; 56.35 cm squared

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lovaza 4gm oral (Dietary_supplement); Raloxifene 60 Mg Oral Tablet (Drug); Raloxifene 30 Mg Oral Tablet (Drug); Lovaza 4gm & Raloxifene 30mg (Drug)
Age
Adult, Older Adult · 35+ yrs
Sex
Female
Sponsor
Milton S. Hershey Medical Center
Primary completion
Apr 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Absolute Breast Density
65.53; 64.39; 65.08; 56.35; 63.81; 59.29
SECONDARY
Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
544; 366; 530; 440; 444; 484
SECONDARY
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
255; 285; 213; 184; 355; 224
SECONDARY
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
10.57; 8.58; 8.82; 7.15; 15.6; 7.46
SECONDARY
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
2.39; 0.91; 1.67; 1.22; 4.28; 2.19
SECONDARY
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
4.96; 4.63; 4.80; 4.95; 4.89; 5.05
SECONDARY
Changes in Serum Lipid Levels
207.3; 203.6; 204.3; 197.7; 197.6; 208.8
SECONDARY
Changes in Complete Blood Count: Red Blood Cells
4.31; 4.25; 4.30; 4.33; 4.24; 4.27
SECONDARY
Changes in Complete Blood Count: Hemoglobin
13.09; 13.11; 12.73; 13.25; 13.35; 12.97
SECONDARY
Changes in Complete Blood Count: Hematocrit
39.14; 38.95; 38.79; 39.09; 39.20; 38.83
SECONDARY
Changes in Complete Blood Count: White Blood Cells and Platelets
5.13; 5.47; 5.00; 5.04; 5.27; 5.15

Summary

The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to the crosstalk of their downstream cellular effects leading to decreased proliferation and increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that upregulation of functional estrogen receptors in the premalignant lesions is also responsible for the development of hormone independent tumors, the investigators postulate that the combination of antiestrogens and omega-3 fatty acids will reduce the development of both hormone-dependent and -independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors, which are more prevalent, more aggressive, leading to the patient's demise. In addition, the investigators postulate that this approach will be safe since it will combine a lower and hence a less toxic dose of Raloxifene with the administration of omega-3 fatty acids which are known to have health benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive effect in breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy
  • Breast density greater than 25%
  • No hormone replacement therapy for at least six months prior to entry into this study
  • Non-smokers.

Exclusion Criteria

  • History of stroke, pulmonary embolism or deep vein thrombosis
  • History of atherosclerotic heart disease
  • Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)
  • Diabetes mellitus
  • Uncontrolled hypertension (BP ≥140/90)
  • Presence of a psychiatric condition that would interfere with adherence to the protocol.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00723398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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