Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study
Condition: Chemo Brain; Chemotherapy-related Cognitive Impairment; Chemo Fog; Breast Cancer; Chemobrain
MeSH terms: Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction
Intervention: Transdermal nicotine; Placebo Transdermal Patch
Intervention description: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.; Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: Female
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chemo brain; Chemotherapy-related cognitive impairment; CRCI; Breast cancer; Chemo fog; Nicotine; Transdermal nicotine

Summary:

      The purpose of this study is to evaluate the use of a nicotine patch as a treatment for
      problems with attention, learning and memory in breast cancer patients who are 1-5 years post
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All participants will:

               1. Be between 35 and 80 years of age,

               2. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast
                  cancer,

               3. Have undergone treatment with systemic chemotherapy within the last 1-5 years,

               4. Endorse persistent CRCI subjective complaints,

               5. Be non-smokers (no nicotine use within the last 5 years),

               6. Have no active cardiac, neurologic, or psychiatric illness, and

               7. Fluent in and able to read English.

        Exclusion Criteria:

          -  Participants will be excluded for:

               1. Any active neurologic and/or psychiatric disease, history of significant head
                  trauma followed by persistent neurologic deficits, or known structural brain
                  abnormalities,

               2. Current major depression or another major psychiatric disorder as described in
                  DSM-5 (use of CNS active medications (e.g. antidepressants) will be permitted,
                  provided dosing has been stable for at least 3 months),

               3. Any history of alcohol or substance abuse or dependence within the past 2 years
                  (DSM-5 criteria),

               4. Any significant systemic illness or unstable medical condition which could lead
                  to difficulty complying with the protocol including:

          -  History of myocardial infarction in the past year or unstable, severe cardiovascular
             disease including angina or CHF with symptoms at rest, or clinically significant
             abnormalities on the ECG

          -  Clinically significant and/or unstable pulmonary, gastrointestinal, hepatic, or renal
             disease

          -  Insulin-requiring diabetes or uncontrolled diabetes mellitus,

          -  Uncontrolled hypertension (systolic BP> 170 or diastolic BP> 100), 5. Use of any
             investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to
             screening, and 6. Use of any drugs with pro-cholinergic properties (e.g. donepezil).