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Phase III Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors with Cognitive Impairment.

Research & Trial Information

SCHEMA WF 97116

Protocol #: Wake Forest – WF97116

Cancer Type: Cancer Control Breast

Inclusion Criteria:

  1. Women ≥18 years old with history of invasive breast cancer
  2. Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to enrollment (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).
  3. Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study enrollment and plan to continue for the duration of the study (9 months).
  4. Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks.
  5. Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen HVLT-R Form C).
  6. ECOG performance status 0-2
  7. Must be able to speak English

Exclusion Criteria:

  1. Evidence or suspected recurrent or metastatic disease. Prior brain irradiation is not allowed.
  2. Patients may not currently be taking Quinidine, Certinib, Highest Risk QTc-Prolonging Agents, MiFEPRIStone, or Succinylcholine.
  3. History of dementia, Alzheimer’s disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed)
  4. Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to enrollment.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil.
  6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia.
  7. Traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
  8. Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.
  9. Untreated current severe depression. Currently treated depression is permitted if treatment is stable.
  10. Patients with bradycardia, seizure disorder or peptic ulcer disease (PUD)

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