A Randomized Controlled Multicenter Trial of a Nutritional Formula in Women with Mastalgia Associated with Fibrocystic Breast Changes.

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Abstract Objective: Nodularity is a problem for clinical and radiological evaluation of the breast. A randomized, controlled, double-blinded trial was performed in women with cyclic breast pain (mastalgia) associated with fibrocystic breast changes to determine the effect of a liquid nutritional formula on breast pain and nodularity.Study Design: Following a one month baseline assessment, women were randomly assigned to receive 4 ounces per day of an experimental (EXP) or control liquid nutritional formula (CONT) for three months. The EXP contained 1 gram of gamma linolenic acid (GLA) (as borage oil), 750 mcg of iodine (as potassium iodide), and 70 mcg of selenium (as sodium selenate). The CONT was an isonitrogenous, isocaloric formula prepared with high-oleic safflower oil in place of borage oil, and without additional GLA, iodine, or selenium. Women were asked to record breast pain, supplemental medications, and menstrual signs daily using an interactive voice-response system (IVRS). Physical breast exams were performed by a healthcare professional at baseline and at the end of the study for a determination of nodularity.Results: A total of 503 women were screened for eligibility from 21 centers distributed across the United States. From this group, 188 women were randomized to receive the EXP or CONT intervention. The groups were similar at baseline. Peak breast pain scores were reduced from baseline similarly in the EXP (-32.2%) and CONT (-33.1%) groups (p=0.64). Among women who continued to take non-prescription pain medication for management of breast pain, the amount of medication was significantly less in the EXP group (p=0.0143). In addition, there was a greater reduction in breast nodularity in women taking the EXP compared to the CONT (p=0.03 vs. p=0.64). Both groups reported similar average weight at baseline, but women in the EXP lost an average of 2.6 lbs. of body weight, while those in the CONT gained an average of 3.6 lbs by the end of the study. Both formulas were well tolerated and willingness to consume the nutritional intervention was 82.7% in the CONT and 90.4% in the EXP as calculated by the number of voluntary withdrawals from the study and discontinuation of treatment for any reason. Women were considered compliant if the consumed at least 70% of the study product (daily reported by IVRS).Conclusion: These results indicate that the daily liquid nutritional formula containing GLA, iodine, and selenium may provide a safe nutritional alternative for reducing both nodularity and nonprescription medication use associated with cyclic breast pain in women with fibrocystic breast changes. Reduction in nodularity may improve physician and mammographic evaluation of the breast. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5034.

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