Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT01821833
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01821833
Study Brief:
Protocol Section:
NCT01821833