Smoking Cessation Treatment for Head and Neck Cancer Patients

What Was Tested

In this early phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

This is a pilot research study examining the use of varenicline (Chantix) and the nicotine patch.

The study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.

It had two arms (groups): Varenicline (Chantix) (active comparator) and Nicotine Patch (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 7 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age 18 or older. Smoking 10 or more cigarettes per day. Diagnosed with and completed an initial course of treatment for any type of head and neck cancer. Life expectancy of 12 months or more.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: history of allergic reactions to adhesives; unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2009-07 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To develop an effect size estimate for smoking cessation defined as continuous abstinence over the last 4 weeks of treatment for [amount hidden] varenicline compared to nicotine patch.

It also tracked 3 secondary outcomes, for example To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation and To examine the effect of varenicline and nicotine patch on alcohol consumption.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 7 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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