CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Transdermal nicotine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02312934
NCT02312934Phase 2Completed
CompareCT.gov

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

Vanderbilt University Medical Center·interventional·Posted Dec 9, 2014·Updated Jan 21, 2020

In Brief

A Phase 2 clinical trial evaluating Transdermal nicotine and Placebo Transdermal Patch for Chemo Brain and 4 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemo Brain, Chemotherapy-related Cognitive Impairment, Chemo Fog, Breast Cancer, Chemobrain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 9, 2014
Enrollment StartAug 1, 2015
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.6 years ago

Interventions

Transdermal nicotinedrug

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.

Placebo Transdermal Patchother

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.