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NCT01478477 · ClinicalTrials.gov registry record · NA

Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole

A NA study, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
NA
Development phase
44
Enrollment target

NCT01478477: Completed NA study, sponsored by Ohio State University Comprehensive Cancer Center.

NCT01478477 is a NA study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01478477, a NA study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

COMPLETED
Registry status
NA
Development phase
44 participants
Enrollment target

Study Summary

This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer.

Primary Outcome

Pain scores based on FACT-B/ES, HAS and BPI will be plotted over time for each arm. Agreement between HAS, BPI-short and FACT-B/ES evaluated using Altman and Bland plot after proper data transformation. Also, Linear Mixed model used to explore if the pain scores are different at 3 and 6 months. Logistic regression models used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups, with potential covariates including age, body mas

Interventions

  • OTHER Placebo
  • PROCEDURE Magnetic Resonance Imaging
  • DIETARY_SUPPLEMENT omega-3 fatty acid supplement
  • OTHER Clinical assessments
  • OTHER Assessment of therapy complications

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2011-10-04
Est. Completion 2014-01-09
Phase NA

What the finished NCT01478477 record still lists

NCT01478477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01478477 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01478477 about?

NCT01478477 is a clinical study titled "Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole". This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast...

What is the current status of trial NCT01478477?

This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2011-10-04. Estimated completion is 2014-01-09.

What interventions are being tested in trial NCT01478477?

The interventions under investigation include: Placebo (OTHER), Magnetic Resonance Imaging (PROCEDURE), omega-3 fatty acid supplement (DIETARY_SUPPLEMENT), Clinical assessments (OTHER), Assessment of therapy complications (OTHER).

Who is sponsoring clinical trial NCT01478477?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01478477's enrollment target sits among peer trials

44 1423rd of 2000 higher than 566 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01478477, the US trial registry maintained by the National Library of Medicine. NCT01478477 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.