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NCT01821833 · ClinicalTrials.gov registry record · NA
Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel
A NA study of Breast Cancer and Pain, sponsored by New Mexico Cancer Research Alliance.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT01821833: Completed NA study of Breast Cancer and Pain, sponsored by New Mexico Cancer Research Alliance.
NCT01821833 is a NA study of Breast Cancer and Pain that has completed, run by New Mexico Cancer Research Alliance. The registered enrollment target is 60 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01821833, a NA study of Breast Cancer and Pain, has completed, sponsored by New Mexico Cancer Research Alliance.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side effects including neuropathy (weakness, numbness and pain) and generalized body aches. The latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and often occurs in the first three to four days after administration. It affects about 58-90% of patients. Currently, the mechanism of P-APS is unknown, and there is no standard of care to treat it. However, an intervention with both anti-inflammatory as well as neuroprotective properties would be an ideal candidate for testing in the prevention of P-APS and subsequent development of peripheral neuropathy. Previous studies have suggested that omega-3 fatty acids may act as neuroprotective agents, and there are no currently documented safety concerns with their combined use with paclitaxel. Therefore, this randomized pilot clinical trial will determine whether omega-3 fatty acids can treat pain in patients with breast or ovarian cancer receiving paclitaxel.
Primary Outcome
Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DRUG Paclitaxel
- DIETARY_SUPPLEMENT Omega-3 fatty acid
Study Locations (2)
New Mexico
- University of New Mexico Comprehensive Cancer Center - Albuquerque
- Presbyterian Medical Group - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-05-24 |
| Est. Completion | 2022-08-03 |
| Phase | NA |
What the finished NCT01821833 record still lists
NCT01821833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01821833 reports a single indexed study location in New Mexico.
Frequently Asked Questions
What is clinical trial NCT01821833 about?
NCT01821833 is a clinical study titled "Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel". Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side effects including neuropathy (weakness, numbness and pain) and generalized body aches. The latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and often occurs in the firs...
What is the current status of trial NCT01821833?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2016-05-24. Estimated completion is 2022-08-03.
What conditions does trial NCT01821833 study?
This clinical trial studies the following conditions: Breast Cancer, Pain, Ovarian Neoplasm.
What interventions are being tested in trial NCT01821833?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Paclitaxel (DRUG), Omega-3 fatty acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01821833?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01821833 being conducted?
This trial has 2 study locations across New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01821833's enrollment target sits among peer trials
60 736th of 1224 higher than 468 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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