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NCT01869764 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
57
Enrollment target
1
Study location

NCT01869764: Completed Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by Wake Forest University Health Sciences.

NCT01869764 is a Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 57 participants, below the 317-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01869764, a Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER placebo
  • DRUG omega-3 fatty acid

Study Locations (1)

North Carolina

  • Comprehensive Cancer Center of Wake Forest University - Winston-Salem

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2013-11
Est. Completion 2018-07
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT01869764 record still lists

NCT01869764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 317-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (82% lower).

The record links to 9 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT01869764 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT01869764 about?

NCT01869764 is a clinical study titled "Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer". 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 a...

What is the current status of trial NCT01869764?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2013-11. Estimated completion is 2018-07.

What conditions does trial NCT01869764 study?

This clinical trial studies the following conditions: Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Male Breast Cancer.

What interventions are being tested in trial NCT01869764?

The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), omega-3 fatty acid (DRUG).

Who is sponsoring clinical trial NCT01869764?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01869764 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stage II Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01869764's enrollment target sits among peer trials

57 21st of 30 higher than 10 of 30 other Stage II Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage II Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01869764, the US trial registry maintained by the National Library of Medicine. NCT01869764 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.