Breast CancerNCT00723398

Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

A study testing Lovaza 4gm oral, Raloxifene 60 Mg Oral Tablet and Raloxifene 30 Mg Oral Tablet in people with Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Lovaza 4gm oral, Raloxifene 60 Mg Oral Tablet and Raloxifene 30 Mg Oral Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Apr 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer

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.

Read the detailed description

The main objectives of this study are to determine the individual and combined effects of Raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in healthy, postmenopausal women. The primary endpoint will be mammographic density for which the study has been powered. Breast density is a major risk factor for breast cancer and hence it is chosen to evaluate the potential chemopreventive efficacy of our interventions. Secondary endpoints would include markers of oxidative stress, parameters of estrogen metabolism, markers of inflammation, and markers of IGF-I signaling, all of which have been shown in the literature to have an influence on mammary carcinogenesis.

Study Population: Healthy, postmenopausal women between the ages of 35-70 years, undergoing yearly mammograms as part of routine screening practice.

Method of Identification of Subjects/Samples/Medical Records: Women reporting for yearly mammograms will be considered for this protocol. They will be given first a screening questionnaire to rule out any co-existing medical condition that would predispose them to thromboembolic events.

Conditions: Breast Cancer
Being tested: Lovaza 4gm oral, Raloxifene 60 Mg Oral Tablet, Raloxifene 30 Mg Oral Tablet, Lovaza 4gm & Raloxifene 30mg
Keywords: omega-3 fatty acids, antiestrogens, breast cancer prevention, breast density, biomarkers of mammary carcinogenesis
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lovaza 4gm oralDietary supplement
Also called Omega-3 Fatty Acid Capsules; Fish Oil capsules; Triklo
Dietary supplement; Take 4 mg oral capsules daily
Raloxifene 60 Mg Oral TabletDrug
Also called Evista 60 Mg Oral Tablet
60 mg orally every day for two years
Raloxifene 30 Mg Oral TabletDrug
Also called Evista 30 Mg Oral Tablet
30 mg orally daily for two years
Lovaza 4gm & Raloxifene 30mgDrug
Also called Pitavastatin 4 gm and Evista 30 mg oral tablet
Lovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years

Study groups in NCT00723398
Study group	Role	What they receive
Group 1: Control	No intervention	Control, no intervention
Group 2: Raloxifene 60 Mg Oral Tablet	Experimental	Raloxifene 60 mg Orally Daily Receives: Drug: Raloxifene 60 Mg Oral Tablet
Group 3: Raloxifene 30 Mg Oral Tablet	Experimental	Raloxifene 30 mg Orally Daily Receives: Drug: Raloxifene 30 Mg Oral Tablet
Group 4: Lovaza 4 gm oral	Experimental	Lovaza 4 gm/day Orally with Meals Receives: Dietary Supplement: Lovaza 4gm oral
Group 5: Lovaza 4gm & Raloxifene 30mg	Experimental	Lovaza 4 gm/day oral capsule with meals plus Raloxifene 30 mg oral tablet daily Receives: Drug: Lovaza 4gm & Raloxifene 30mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Absolute Breast Density
Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.
Measured: 2 years

Secondary outcomes (10)

Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-(isoprostane) F-2α as measured through urine analysis.
Measured: 1 year
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-hydroxy-deoxyguansine as measured through urinary analysis.
Measured: 1 year
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
Changes in biomarkers for estrogen metabolism: 2-hydroxy estrone (Urinary 2-OHE1) and 16-α-hydroxy estrone (16α-OHE1) as measured by urinary analysis. Specific time points for evaluation are baseline and Year +1 (only).
Measured: 1 year
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
Changes in serum biomarkers for inflammation including highly sensitive C-reactive protein and IL-6 obtained through a blood draw. Specific time points for evaluation are baseline and Year +1 (only).
Measured: 1 Year
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
Changes in insulin-like growth factor-1 (IGF-1) and insulin-like growth factor-1 binding protein-3 (IGFBP-3) obtained through blood sample. Specific time points for evaluation are baseline and Year +1 (only).
Measured: 1 year
Changes in Serum Lipid Levels
Changes in serum lipid levels as measured through total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Specific time points for evaluation are baseline, Year +1, and Year 2.
Measured: 2 years
Changes in Complete Blood Count: Red Blood Cells
Changes in complete blood count levels as measured through red blood cells (RBC). Specific time points for evaluation are baseline, Year +1, and Year 2.
Measured: 2 years
Changes in Complete Blood Count: Hemoglobin
Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.
Measured: 2 years
Changes in Complete Blood Count: Hematocrit
Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.
Measured: 2 years
Changes in Complete Blood Count: White Blood Cells and Platelets
Changes in complete blood count levels as measured through white blood cells (WBC) and platelets. Specific time points for evaluation are baseline, Year +1, and Year 2.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Apr 2015

First posted28 Jul 2008 (estimated)
Study startMar 2009
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00723398
Sponsor's protocol ID: 26970
Status last verified: Oct 2018
First submitted: 24 Jul 2008
Last updated: 1 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Manni A, Richie JP, Schetter SE, Calcagnotto A, Trushin N, Aliaga C, El-Bayoumy K. Stearoyl-CoA desaturase-1, a novel target of omega-3 fatty acids for reducing breast cancer risk in obese postmenopausal women. Eur J Clin Nutr. 2017 Jun;71(6):762-765. doi: 10.1038/ejcn.2016.273. Epub 2017 Feb 1.
PubMed 28145413

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer
ClinicalTrials.gov ID: NCT00723398
Acronym / sponsor ID: 26970
Conditions: Breast Cancer
Keywords: omega-3 fatty acids, antiestrogens, breast cancer prevention, breast density, biomarkers of mammary carcinogenesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Study start: Mar 2009
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 28 Jul 2008 (estimated)
Results: Posted 1 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Population: Healthy, postmenopausal women between the ages of 35-70 years, undergoing yearly mammograms as part of routine screening practice.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1: Control	No intervention	–Control, no intervention
Group 2: Raloxifene 60 Mg Oral Tablet	Experimental	Drug: Raloxifene 60 Mg Oral TabletRaloxifene 60 mg Orally Daily
Group 3: Raloxifene 30 Mg Oral Tablet	Experimental	Drug: Raloxifene 30 Mg Oral TabletRaloxifene 30 mg Orally Daily
Group 4: Lovaza 4 gm oral	Experimental	Dietary Supplement: Lovaza 4gm oralLovaza 4 gm/day Orally with Meals
Group 5: Lovaza 4gm & Raloxifene 30mg	Experimental	Drug: Lovaza 4gm & Raloxifene 30mgLovaza 4 gm/day oral capsule with meals plus Raloxifene 30 mg oral tablet daily

Who may qualify

Ages: 35 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lovaza 4gm oralAlso: Omega-3 Fatty Acid Capsules; Fish Oil capsules; TrikloDietary supplement; Take 4 mg oral capsules daily	Dietary supplement	Group 4: Lovaza 4 gm oral
Raloxifene 60 Mg Oral TabletAlso: Evista 60 Mg Oral Tablet60 mg orally every day for two years	Drug	Group 2: Raloxifene 60 Mg Oral Tablet
Raloxifene 30 Mg Oral TabletAlso: Evista 30 Mg Oral Tablet30 mg orally daily for two years	Drug	Group 3: Raloxifene 30 Mg Oral Tablet
Lovaza 4gm & Raloxifene 30mgAlso: Pitavastatin 4 gm and Evista 30 mg oral tabletLovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years	Drug	Group 5: Lovaza 4gm & Raloxifene 30mg

Primary outcome

Change in Absolute Breast Density
Time frame: 2 years
Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.

10 secondary outcomes

Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
Time frame: 1 year
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
Time frame: 1 year
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
Time frame: 1 year
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
Time frame: 1 Year
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
Time frame: 1 year
Changes in Serum Lipid Levels
Time frame: 2 years
Changes in Complete Blood Count: Red Blood Cells
Time frame: 2 years
Changes in Complete Blood Count: Hemoglobin
Time frame: 2 years
Changes in Complete Blood Count: Hematocrit
Time frame: 2 years
Changes in Complete Blood Count: White Blood Cells and Platelets
Time frame: 2 years

Results and safety

Results posted to the registry on 1 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Control	53	47
Group 2: Raloxifene 60 mg	53	38
Group 3: Raloxifene 30 mg	53	36
Group 4: Lovaza 4 gm	54	49
Group 5: Lovaza 4 gm and Raloxifene 30 mg	53	44

Primary outcome: Change in Absolute Breast Density

Time frame: 2 years. Mean (Standard Deviation). Unit: cm squared

Measure	Group 1: Control n = 53	Group 2: Raloxifene 60 mg n = 53	Group 3: Raloxifene 30 mg n = 53	Group 4: Lovaza 4 gm n = 54	Group 5: Lovaza 4 gm and Raloxifene 30 mg n = 53
Absolute density at baseline	65.53 (59.43)	64.39 (39.95)	65.08 (34.47)	56.35 (22.61)	63.81 (29.81)
Absolute density at 1 year	59.29 (40.72)	60.48 (38.89)	59.53 (30.32)	58.87 (22.21)	60.93 (24.64)
Absolute density at 2 years	54.34 (20.11)	60.57 (35.10)	58.86 (27.93)	57.60 (20.77)	28.53 (25.18)

Population analysed: The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Control	0 of 53 (0%)	1 of 53 (1.9%)	Not reported
Group 2: Raloxifene 60 mg	1 of 53 (1.9%)	10 of 53 (18.9%)	Not reported
Group 3: Raloxifene 30 mg	0 of 53 (0%)	7 of 53 (13.2%)	Not reported
Group 4: Lovaza 4 gm	0 of 54 (0%)	0 of 54 (0%)	Not reported
Group 5: Lovaza 4 gm and Raloxifene 30 mg	0 of 53 (0%)	6 of 53 (11.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28145413Manni A, Richie JP, Schetter SE, Calcagnotto A, Trushin N, Aliaga C, El-Bayoumy K. Stearoyl-CoA desaturase-1, a novel target of omega-3 fatty acids for reducing breast cancer risk in obese postmenopausal women. Eur J Clin Nutr. 2017 Jun;71(6):762-765. doi: 10.1038/ejcn.2016.273. Epub 2017 Feb 1.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
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Not yet recruitingObservational study
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrea Manni, MD principal investigator

Penn State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lovaza 4gm oral, Raloxifene 60 Mg Oral Tablet and Raloxifene 30 Mg Oral Tablet in people with Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Absolute Breast Density (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00723398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.