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

What Was Tested

This registered phase 2 trial tested Therapeutic nicotine (patch, non-peptide).

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.

It had two arms (groups): Transdermal Nicotine (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

As a result, patients who receive chemotherapy for breast cancer may experience problems with their attention, learning, and memory that they did not have before receiving chemotherapy.

This study is designed to test whether nicotine treatment is helpful for learning and memory problems after chemotherapy for breast cancer.

Participants will be assessed before, during, and at the end of treatment.

At the end of the 8-week study, participants will have the option to take part in the open-label portion of the study for an additional 6 weeks.

Who Took Part

The registry lists 22 actual participants took part.

It was open to women only aged from 35 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: All participants will:. 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,.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: participants will be excluded for:; any history of alcohol or substance abuse or dependence within the past 2 years (dsm-5 criteria),; insulin-requiring diabetes or uncontrolled diabetes mellitus,.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-08 with completion listed for 2018-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale (time frame: Baseline to 8-Weeks).

It also tracked 1 secondary outcome, for example Conners Continuous Performance Test.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.