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A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy

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Abstract

Purpose

Some breast cancer survivors report cognitive difficulties greater than 1 year after chemotherapy. Acetylcholinesterase inhibitors (AChEI) may improve cognitive impairment. We conducted a randomized, placebo-controlled, pilot study to assess the feasibility of using the AChEI, donepezil, to improve subjective and objective measures of cognitive function in breast cancer survivors.

Methods

Women who received adjuvant chemotherapy 1–5 years prior with current cognitive dysfunction symptoms were randomized to 5 mg of donepezil/day vs placebo for 6 weeks and if tolerated 10 mg/day for 18 weeks for a total of 24 weeks. A battery of validated measures of attention, memory, language, visuomotor skills, processing speed, executive function, and motor dexterity and speed was administered at baseline and at 24 and 36 weeks. Subjective cognitive function, fatigue, sleep, mood, and health-related quality of life were evaluated at baseline and at 12, 24, and 36 weeks.

Results

Sixty-two patients were enrolled, 76 % completed the study, self-reported compliance was 98 %, and toxicities were minimal. At the end of treatment, the donepezil group performed significantly better than the control group on two parameters of memory—the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall (p = 0.033) and HVLT-R Discrimination (p = 0.036). There were no significant differences on other cognitive variables or in subjective cognitive function or quality of life.

Conclusion

Accrual to this feasibility trial was robust, retention was good, compliance was excellent, and toxicities were minimal.

Implications for Cancer Survivors

Randomized clinical trials in breast cancer survivors to improve cognitive dysfunction are feasible. A phase III trial testing the efficacy of donepezil is warranted given these pilot results.

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Acknowledgments

The Wake Forest Community Clinical Oncology Program Research Base is funded by NCI/DCP grant 2U10CA081851.

Conflict of interest

There are no conflicts of interest to disclose.

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Authors and Affiliations

  1. Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA

    J. A. Lawrence, L. Griffin, G. J. Lesser, M. J. Naughton, L. D. Case, E. G. Shaw & S. R. Rapp

  2. Michigan CCOP, St. Mary’s of Michigan, Saginaw, MI, 48602, USA

    E. P. Balcueva

  3. St. Vincent CCOP, Green Bay Oncology, Green Bay, WI, 54301, USA

    D. L. Groteluschen

  4. Medical College of Georgia MBCCOP, Augusta, GA, 30912, USA

    T. A. Samuel

  5. Department of Hematology and Oncology, Wake Forest University School of Medicine, Medical Center Blvd., Winston-Salem, NC, 27157, USA

    J. A. Lawrence & G. J. Lesser

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  1. J. A. Lawrence
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  2. L. Griffin
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  3. E. P. Balcueva
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  4. D. L. Groteluschen
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  5. T. A. Samuel
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  6. G. J. Lesser
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  7. M. J. Naughton
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  8. L. D. Case
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  9. E. G. Shaw
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  10. S. R. Rapp
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Correspondence to J. A. Lawrence.

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Lawrence, J.A., Griffin, L., Balcueva, E.P. et al. A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy. J Cancer Surviv 10, 176–184 (2016). https://doi.org/10.1007/s11764-015-0463-x

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  • DOI: https://doi.org/10.1007/s11764-015-0463-x

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