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      Modafinil Improves Cognitive Performance in Breast Cancer Survivors: Presented at AGS

      By Crina Frincu-Mallos, PhD

      WASHINGTON, DC -- May 12, 2008 -- Modafinil therapy appears to improve memory and attention skills in breast cancer survivors treated with chemotherapy, according to research reported here at the 2008 Annual Scientific Meeting of the American Geriatrics Society (AGS).

      In older patients who undergo chemotherapy for treatment of breast cancer, persistent fatigue is a common treatment-related adverse effect, responsible for poor quality of life.

      In a randomised clinical trial, researchers examined the effects of modafinil on persistent fatigue as well as on memory and concentration in 82 patients who received treatment for breast cancer. All patients had a score of 2 or greater on the Brief Fatigue Inventory.

      Lead author Sadhna Kohli, PhD, MPH, Assistant Professor, Cancer Therapeutic Control, Radiation Oncology, University of Rochester, Rochester, New York, discussed the study results in a poster presentation on May 1.

      The study consisted of 2 treatment phases: all patients received open-label modafinil 200 mg once daily for 4 weeks, and those with improvement in fatigue outcomes subsequently were randomised to an additional 4 weeks of modafinil or to placebo.

      Patients underwent tests of cognitive performance at baseline, after phase 1, and at the completion of phase 2.

      Of the 82 women enrolled, 76 completed phase 1 and were tested for memory and attention. Sixty-eight subjects completed phase 2 and were able to complete all assessments in the study, said the investigators.

      For the purpose of this analysis, the patients were divided into 2 age groups: up to 64 years and 65 years or older. The results were analysed for these subgroups as well as a whole group. However, the researchers observed no statistically significant findings when they compared the 2 age subgroups, Dr. Kohli said.

      At the completion of phase 1, modafinil had a significant effect on Quality of Episodic Memory (P < .001) and on Speed of Memory (P < .0003) compared with baseline, regardless of age, explained Dr. Kohli.

      For patients who completed phase 2 of the study, those randomised to modafinil had a significant improvement in Speed of Memory (P = .006) and Quality of Episodic Memory (P = .03) relative to the patients on the placebo arm.

      In addition, patients who continued with modafinil in phase 2 demonstrated improved Mean Continuity of Attention compared with the placebo group (P = .01).

      Although further study is needed, the improved cognitive performance in breast cancer survivors in this study suggests that treatment with modafinil may result in a better quality of life in this patient population, concluded Dr. Kohli and colleagues.

      Funding for this study was provided by Cephalon, Inc., and the US National Cancer Institute.

      [Presentation title: Managing Chemotherapy-Induced Cognitive Impairment in Breast Cancer Patients. Abstract B135]



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