Status:
COMPLETED
Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel
Lead Sponsor:
New Mexico Cancer Research Alliance
Collaborating Sponsors:
Alliance Healthcare Foundation
Conditions:
Breast Cancer
Ovarian Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
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 recen...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 24 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01821833
Start Date
May 24 2016
End Date
August 3 2022
Last Update
October 5 2022
Active Locations (2)
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1
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87106
2
Presbyterian Medical Group
Albuquerque, New Mexico, United States, 87110