- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821833
Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel
A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome
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 Overview
Status
Conditions
Intervention / Treatment
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 2.7 g/day of EPA and DHA have been reported to have analgesic effects in inflammatory conditions. The dose of 4 g/day 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 g/day 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87110
- Presbyterian Medical Group
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Albuquerque, New Mexico, United States, 87106
- University of New Mexico Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients have a diagnosis of breast cancer or ovarian cancer
- Patients are scheduled to receive weekly paclitaxel at 70-90 mg/m^2 for a minimum of 2 months; 3 out of 4 weeks is allowed
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- Patients must not have taken omega-3-fatty acid supplements within the past 1 month prior to registration and must agree to refrain from use of omega- 3 fatty acid supplements from sources outside the study
- Patients must not be on nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin for at least 1 week prior to registration; NSAIDS or aspirin are allowed after enrollment
- Patients must not have received any other analgesics (opiates and tramadol) 1 week prior to registration; analgesics (opiates and tramadol) are allowed after enrollment
- Patients must have the ability to complete questionnaires by themselves or with assistance
- Patients must not be on anticoagulation medication (heparin/ warfarin) within 28 days prior to registration, because of increased risk of bleeding
- Concurrent treatment with carboplatin +/- bevacizumab is allowed
- Concurrent treatment with human epidermal growth factor receptor (Her2 neu) targeted therapy is allowed
Exclusion Criteria:
- Known allergy to omega 3 fatty acids, fish or shellfish
- Pre-existing diagnosis of peripheral neuropathy
- Diagnosis of fibromyalgia
- Concurrent planned neutrophil colony stimulating factor therapy
- Prior exposure to paclitaxel within the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (Omega-3 fatty acid)
Four Omega-3 fatty acid capsules (at 1 gram/capsule) are administered orally daily. The capsules may be administered either once daily or as 2 capsules two times daily. |
Patients receive omega-3 fatty acid capsules orally beginning 1 week prior to paclitaxel treatment. Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first). Each 1-gram capsule contains approximately 465 mg eicosapentaenoic acid (EPA) and 375 mg docosahexaenoic acid (DHA).
Other Names:
Patients will receive, as part of their standard of care, weekly paclitaxel at 70 to 90 mg/m2 intravenously for a minimum of 2 months.
Treatment 3 out of 4 weeks is allowed.
Other Names:
|
Placebo Comparator: Arm II (placebo)
Four placebo capsules (at 1 gram microcrystalline cellulose/capsule) are administered orally daily. The capsules may be administered either once daily or as 2 capsules two times daily. |
Patients will receive, as part of their standard of care, weekly paclitaxel at 70 to 90 mg/m2 intravenously for a minimum of 2 months.
Treatment 3 out of 4 weeks is allowed.
Other Names:
Patients receive placebo capsules orally beginning 1 week prior to paclitaxel treatment. Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean severity of pain
Time Frame: Up to 1 month after completion of therapy
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Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.
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Up to 1 month after completion of therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of pain or relief
Time Frame: Up to 1 month after completion of therapy
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Fisher's exact test will be used for the incidence variable with 95% confidence intervals.
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Up to 1 month after completion of therapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zoneddy Dayao, University of New Mexico Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- INST 1211
- NCI-2013-00443 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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