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

• Status: Active, not recruiting
• Trial end date: 2021-08-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Collaborator: Alliance Healthcare Foundation
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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