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Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by New Mexico Cancer Care Alliance
Sponsor:
Collaborator:
Alliance Healthcare Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01821833
First received: March 27, 2013
Last updated: June 7, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention
Breast Cancer
Ovarian Neoplasm
Pain
Dietary Supplement: Omega-3 fatty acid
Dietary Supplement: Placebo
Drug: Paclitaxel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Mean severity of pain [ Time Frame: Up to 1 month after completion of therapy ] [ Designated as safety issue: No ]
    Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.


Secondary Outcome Measures:
  • Incidence of pain or relief [ Time Frame: Up to 1 month after completion of therapy ] [ Designated as safety issue: No ]
    Fisher's exact test will be used for the incidence variable with 95% confidence intervals.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Dietary Supplement: Omega-3 fatty acid

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:
  • Fish oil
  • n-3 fatty acid
  • O3FA
  • Lovaza
Drug: Paclitaxel
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 Name: Taxol
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.

Dietary Supplement: Placebo

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)

Drug: Paclitaxel
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 Name: Taxol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821833

Contacts
Contact: Valerie Parks, RN 505-925-0390 vparks@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Comprehensive Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Zoneddy R. Dayao, MD    505-925-5490    zdayao@salud.unm.edu   
Principal Investigator: Zoneddy R. Dayao         
Presbyterian Medical Group Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Wendy Burman, RN    505-559-6113      
Sub-Investigator: Bernard Agbemadzo, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Alliance Healthcare Foundation
Investigators
Principal Investigator: Zoneddy Dayao University of New Mexico Comprehensive Cancer Center
  More Information

Additional Information:
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01821833     History of Changes
Other Study ID Numbers: INST 1211  NCI-2013-00443 
Study First Received: March 27, 2013
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by New Mexico Cancer Care Alliance:
omega-3
fatty acids
paclitaxel
acute pain syndrome
peripheral neuropathy
chemotherapy induced neuropathy

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016