44
Participants
Start Date
October 4, 2011
Primary Completion Date
January 9, 2014
Study Completion Date
January 9, 2014
omega-3 fatty acid supplement
6 capsules per day (4.3 g)x 6 months
Placebo
6 capsules per day (4.3 g)x 6 months. Supplement should be taken with food once per day. No specific food requirements are needed.
Clinical assessments
All three instruments will be administered at baseline, at 3 months, 6 months and at additional time intervals when there is a significant change in therapy (discontinuation/switch, pain medication administration) during routine medical oncology visits.
Assessment of therapy complications
Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Magnetic Resonance Imaging
Optional bilateral hand and wrist MRI imaging will be obtained at baseline and at 6 months to eligible patients who have no contraindications to MRI imaging.
Correlative/special studies
Plasma, RBC, and serum samples from the baseline blood draw will also be stored at -70C for fatty acid and biomarker analyses and repeated at 3 month and 6 month intervals. Samples will be analyzed in batches every 6 months.
Ohio State University Medical Center, Columbus
Cancer and Leukemia Group B
NETWORK
Ohio State University Comprehensive Cancer Center
OTHER