Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel
Public ClinicalTrials.gov record NCT01821833. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01821833
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Omega-3 fatty acid Dietary Supplement
- Placebo Dietary Supplement
- Paclitaxel Drug
Dietary Supplement · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 23, 2016
- Primary completion
- Jan 15, 2018
- Completion
- Aug 2, 2022
- Last update posted
- Oct 4, 2022
2016 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Presbyterian Medical Group | Albuquerque | New Mexico | 87110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01821833, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 4, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01821833 live on ClinicalTrials.gov.