Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT01849250
Status:
COMPLETED
Last Update Posted:
2021-12-28
First Post:
2013-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.
SECONDARY OBJECTIVES:
I. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers
* Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR).
* Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68.
* Change from baseline in CLS-B index determined as follows: (\[number of slides with evidence of at least one CLS-B\]/\[total number of slides examined\]).
* Change from baseline in CLS-B/cm\^2 defined as the number of CLS-B/cm\^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment.
III. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks.
ARM II: Patients receive placebo PO BID for 12 weeks.
I. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.
SECONDARY OBJECTIVES:
I. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers
* Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR).
* Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68.
* Change from baseline in CLS-B index determined as follows: (\[number of slides with evidence of at least one CLS-B\]/\[total number of slides examined\]).
* Change from baseline in CLS-B/cm\^2 defined as the number of CLS-B/cm\^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment.
III. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks.
ARM II: Patients receive placebo PO BID for 12 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-00859 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 12-474 | None | None | View | |
| 12-267 | None | None | View | |
| N01-CN-2012-00034 | None | None | View | |
| DFCI:12- 474 | OTHER | Dana-Farber Cancer Institute (DFCI) | View | |
| AAAK6752 | None | None | View | |
| MSKCC-12-267 | OTHER | Memorial Sloan Kettering Cancer Center (MSK or MSKCC) | View | |
| H-33017 | None | None | View | |
| CUMC: AAAK6752 | None | None | View | |
| 2011-0766 | OTHER | MD Anderson Cancer Center (MDA or MDACC) | View | |
| MDA10-16-01 | OTHER | DCP | View | |
| N01CN00034 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CN35159 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |