Ductal Breast Carcinoma in SituPhase 2NCT01869764

Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer

A Phase 2 study testing omega-3 fatty acid and laboratory biomarker analysis in people with Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, run by Wake Forest University Health Sciences 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

This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Male Breast Cancer
What is being tested?: omega-3 fatty acid and laboratory biomarker analysis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Nov 2013to Jul 2018
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])
Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
Tumor measures at least 1 centimeter on imaging or physical exam

Who cannot join

Any patient with surgery scheduled < 7days after biopsy
Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
Patients who will receive neoadjuvant chemotherapy are not eligible
Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
Patients with an allergy or known hypersensitivity to fish

Trial locations and contacts

1 site in 1 country.

United States1 site

Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma

Read the detailed description

PRIMARY OBJECTIVES:

To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo.

II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo.

III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls.

IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days.

ARM II: Patients receive placebo PO daily for 7-14 days.

Conditions: Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Male Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
Being tested: omega-3 fatty acid, placebo, laboratory biomarker analysis
Medical subject headings: Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms, Male, Breast Neoplasms

What participants receive

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

omega-3 fatty acidDrug
Also called fish oil, n-3 fatty acid, O3FA
Given PO
placeboOther
Also called PLCB
Given PO
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT01869764
Study group	Role	What they receive
Arm I (omega-3 fatty acid)	Experimental	Patients receive omega-3 fatty acid PO daily for 7-14 days. Receives: Drug: omega-3 fatty acid; Other: laboratory biomarker analysis
Arm II (placebo)	Placebo comparator	Patients receive placebo PO daily for 7-14 days. Receives: Other: placebo; Other: laboratory biomarker analysis

What is being measured

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

PUFA Levels in Normal and Metastatic Breast Tissue
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
Measured: At time of surgery
PUFA Levels in Plasma Pre and Post Surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
Measured: Pre and post surgery
PUFA Levels in Red Blood Cells Pre and Post Surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
Measured: Pre and post surgery

Secondary outcomes (3)

Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue
ANOVA will be used to assess the effect in normal and malignant breast tissue. Metabolites tested: PGE2, PGD2, 20-HETE, 5-HEPE, 13-HODE, 9-HODE, 15-HETE, 12-HETE, 5-HETE.
Measured: At time of surgery
Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue
ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with less proliferation in malignant breast tissue in comparison to women who took the placebo.
Measured: At time of surgery
Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue
ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with greater apoptosis in malignant breast tissue in comparison to women who took the placebo.
Measured: At time of surgery

Timeline

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

Nov 2013Jul 2018

First posted5 Jun 2013 (estimated)
Study startNov 2013
Primary completionJul 2018
Study completionJul 2018

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.
Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01869764
Sponsor's protocol ID: IRB00023419
Other IDs: NCI-2013-00963, P30CA012197, CCCWFU 98113
Status last verified: Oct 2019
First submitted: 31 May 2013
Last updated: 30 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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 Ductal Breast Carcinoma in Situ trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma
ClinicalTrials.gov ID: NCT01869764
Acronym / sponsor ID: IRB00023419
Conditions: Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Male Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Nov 2013 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 5 Jun 2013 (estimated)
Results: Posted 30 Oct 2019

Clinical summary

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

Detailed description

PRIMARY OBJECTIVES:

To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo.

II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo.

III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls.

IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days.

ARM II: Patients receive placebo PO daily for 7-14 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (omega-3 fatty acid)	Experimental	Drug: omega-3 fatty acid, Other: laboratory biomarker analysisPatients receive omega-3 fatty acid PO daily for 7-14 days.
Arm II (placebo)	Placebo comparator	Other: placebo, Other: laboratory biomarker analysisPatients receive placebo PO daily for 7-14 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])
Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
Tumor measures at least 1 centimeter on imaging or physical exam

Key exclusion criteria (6 listed)

Any patient with surgery scheduled < 7days after biopsy
Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
Patients who will receive neoadjuvant chemotherapy are not eligible
Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment

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
omega-3 fatty acidAlso: fish oil, n-3 fatty acid, O3FAGiven PO	Drug	Arm I (omega-3 fatty acid)
placeboAlso: PLCBGiven PO	Other	Arm II (placebo)
laboratory biomarker analysisCorrelative studies	Other	Arm I (omega-3 fatty acid), Arm II (placebo)

Primary outcome

PUFA Levels in Normal and Metastatic Breast Tissue
Time frame: At time of surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
PUFA Levels in Plasma Pre and Post Surgery
Time frame: Pre and post surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
PUFA Levels in Red Blood Cells Pre and Post Surgery
Time frame: Pre and post surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3

3 secondary outcomes

Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue
Time frame: At time of surgery
Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue
Time frame: At time of surgery
Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue
Time frame: At time of surgery

Results and safety

Results posted to the registry on 30 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Omega-3 Fatty Acid)	28	28
Arm II (Placebo)	29	27

Primary outcome: PUFA Levels in Normal and Metastatic Breast Tissue

Time frame: At time of surgery. Mean (Standard Deviation). Unit: ug/ml

Measure	Arm I (Omega-3 Fatty Acid) n = 22	Arm II (Placebo) n = 19
Normal breast tissue 18:2 n-6	60.986 (40.392)	72.762 (50.742)
Normal breast tissue 18:3 n-3	3.232 (2.289)	3.505 (2.041)
Normal breast tissue 20:2 n-6	1.104 (0.96)	1.008 (0.724)
Normal breast tissue 20:4 n-6	2.221 (1.349)	2.342 (1.445)
Normal breast tissue 20:3 n-3	0.049 (0.107)	0.038 (0.085)
Normal breast tissue 20:5 n-3	0.027 (0.128)	0.034 (0.147)
Normal breast tissue 22:6 n-3	0.095 (0.443)	0.061 (0.264)
Normal breast tissue n-3	3.402 (2.572)	3.64 (2.24)

Population analysed: All samples measurements were not available for all participants to be analyzed.

Primary outcome: PUFA Levels in Plasma Pre and Post Surgery

Time frame: Pre and post surgery. Mean (Standard Deviation). Unit: ug/ml

Measure	Arm I (Omega-3 Fatty Acid) n = 24	Arm II (Placebo) n = 19
Plasma pre-surgery 18:2 n-6	1514890 (370945)	1539300 (370726)
Plasma pre-surgery 18:3 n-3	37501 (25256)	33119 (19368)
Plasma pre-surgery 20:2 n-6	7039 (6213)	6031 (5612)
Plasma pre-surgery 20:4 n-6	210238 (77734)	210006 (83260)
Plasma pre-surgery 20:3 n-3	0 (0)	0 (0)
Plasma pre-surgery 20:5 n-3	38539 (30967)	50206 (41170)
Plasma pre-surgery 22:6 n-3	132887 (68619)	111798 (79889)
Plasma pre-surgery n-3	208297 (105288)	195123 (106007)

Population analysed: All samples measurements were not available for all participants to be analyzed.

Primary outcome: PUFA Levels in Red Blood Cells Pre and Post Surgery

Time frame: Pre and post surgery. Mean (Standard Deviation). Unit: ug/ml

Measure	Arm I (Omega-3 Fatty Acid) n = 20	Arm II (Placebo) n = 18
Red blood cells pre-surgery 18:2 n-6	351125 (130630)	387455 (119089)
Red blood cells pre-surgery 18:3 n-3	3430 (4505)	3211 (4026)
Red blood cells pre-surgery 20:2 n-6	2826 (3515)	4014 (4183)
Red blood cells pre-surgeryy 20:4 n-6	132624 (68691)	144208 (71426)
Red blood cells pre-surgery 20:3 n-3	0 (0)	0 (0)
Red blood cells pre-surgery 20:5 n-3	9723 (13112)	11005 (14840)
Red blood cells pre-surgery 22:6 n-3	79934 (77518)	90668 (74168)
Red blood cells pre-surgery n-3	0 (0)	0 (0)

Population analysed: All samples measurements were not available for all participants to be analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14-21 days after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Omega-3 Fatty Acid)	0 of 28 (0%)	2 of 28 (7.1%)	0 of 28
Arm II (Placebo)	0 of 27 (0%)	1 of 27 (3.7%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Edward Levine, MD principal investigator

Wake Forest University Health Sciences

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

Questions about this trial

What is this clinical trial studying?

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 30 Oct 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2019). 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?

PUFA Levels in Normal and Metastatic Breast Tissue (time frame: At time of surgery). The study lists 3 primary outcomes in all. 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 NCT01869764.

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 30 Oct 2019.