CompletedPhase 2

Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study

United States22 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range35 Years – 80 Years

SexFEMALE

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Inclusion criteria

✓. Be between 35 and 80 years of age,
✓. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer,
✓. Have undergone treatment with systemic chemotherapy within the last 1-5 years,
✓. Endorse persistent CRCI subjective complaints,
✓. Be non-smokers (no nicotine use within the last 5 years),
✓. Have no active cardiac, neurologic, or psychiatric illness, and
✓. Fluent in and able to read English.

Exclusion criteria

✕. Any active neurologic and/or psychiatric disease, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities,
✕. 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),
✕. Any history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria),
✕. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:

What they're measuring

Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale

Timeframe: Baseline to 8-Weeks

Trial details

NCT IDNCT02312934

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05

Results submitted2019-05-16

View on ClinicalTrials.gov More Chemo Brain trials