Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01821833
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2013-03-27
Brief Title:
Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
A Pilot Randomized Placebo Controlled Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome
Status:
COMPLETED
Status Verified Date:
2022-10
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:
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
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
Detailed Description:
One mechanism proposed for P-APS is an early inflammatory process characterized by macrophage activation in both the dorsal root ganglia and peripheral nerve occurring shortly after paclitaxel therapy Morphologic alterations in DRG satellite cells have been noted and upregulation of proinflammatory cytokines have been hypothesized as early events in the development of neuropathy Therefore it is possible that paclitaxel-induced neuropathic pain may be mediated by pro-inflammatory cytokines If P-APS and chronic neuropathy are indeed part of a continuum the inflammatory pathway would be a reasonable target for therapy While the mechanism of how paclitaxel leads to the development of neuropathy is still not understood it has been hypothesized that its microtubule-stabilizing effects disrupt axonal transport Intervention with an agent that is both anti-inflammatory as well as neuroprotective is therefore worth exploring
Long chain omega-3 fatty acids eicosapentaenoic acid EPA and docosahexaenoic acid DHA are common dietary supplements They have well established anti-inflammatory properties which serve as the basis for their use in therapeutic trials in inflammatory conditions Omega -3 fatty acids consumption can attenuate the production of pro-inflammatory metabolites In addition it can generate local mediators that facilitate resolution of inflammation Thus if P-APS is indeed mediated by inflammation the anti-inflammatory activity of omega 3 fatty acids may be one mechanism to prevent P-APS Additionally given its well established safety profile it may be an attractive alternative to NSAIDS
A dose of at least 27 gday of EPA and DHA have been reported to have analgesic effects in inflammatory conditions The dose of 4 gday is an FDA-approved dose of omega 3 fatty acids Lovaza for the treatment of hypertriglyceridemia and has a well-documented toxicity profile On the basis of this a dose of 4 gday was selected for this study Lovaza omega-3-acid ethyl esters capsules will be used Each 1-gram capsule contains approximately 465 mg EPA and 375 mg DHA
Long chain omega-3 fatty acids eicosapentaenoic acid EPA and docosahexaenoic acid DHA are common dietary supplements They have well established anti-inflammatory properties which serve as the basis for their use in therapeutic trials in inflammatory conditions Omega -3 fatty acids consumption can attenuate the production of pro-inflammatory metabolites In addition it can generate local mediators that facilitate resolution of inflammation Thus if P-APS is indeed mediated by inflammation the anti-inflammatory activity of omega 3 fatty acids may be one mechanism to prevent P-APS Additionally given its well established safety profile it may be an attractive alternative to NSAIDS
A dose of at least 27 gday of EPA and DHA have been reported to have analgesic effects in inflammatory conditions The dose of 4 gday is an FDA-approved dose of omega 3 fatty acids Lovaza for the treatment of hypertriglyceridemia and has a well-documented toxicity profile On the basis of this a dose of 4 gday was selected for this study Lovaza omega-3-acid ethyl esters capsules will be used Each 1-gram capsule contains approximately 465 mg EPA and 375 mg DHA
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2013-00443 | REGISTRY | CTRP Clinical Trial Reporting Program | None |