Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel
Conditions
Breast Cancer - Ovarian Neoplasm - Pain
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
omega-3, fatty acids, paclitaxel, acute pain syndrome, peripheral neuropathy, chemotherapy induced neuropathy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Intervention
Name: omega-3 fatty acid Type: Dietary Supplement
Name: placebo Type: Dietary Supplement
Name: quality-of-life assessment Type: Other
Overall Status
Recruiting
Summary
This randomized pilot clinical trial studies omega-3 fatty acid in treating pain in patients with breast or ovarian cancer receiving paclitaxel. Omega-3 fatty acid may help lessen pain caused by paclitaxel in patients with breast or ovarian cancer.
Detailed Description
PRIMARY OBJECTIVES:

I. To determine whether omega-3 fatty acids can prevent or ameliorate paclitaxel associated pain syndrome (P-APS) in cancer patients.

SECONDARY OBJECTIVES:

I. To determine whether omega-3 fatty acids can prevent development of peripheral neuropathy.

II. To assess tolerability of omega -3 fatty acids in this setting. III. To compare quality of life (QOL) with omega 3 fatty acids supplementation versus placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) or twice daily (BID) for 12 weeks.

ARM II: Patients receive placebo PO QD or BID for 12 weeks.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Presbyterian Medical Group
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: Wendy Burman, RN - 505-559-6113
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Status: Recruiting
Contact: Zoneddy R. Dayao, MD - 505-925-5490 - zdayao@salud.unm.edu
Start Date
February 2013
Completion Date
July 2017
Sponsors
New Mexico Cancer Care Alliance
Source
New Mexico Cancer Care Alliance
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page