Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies

January 27, 2020 updated by: Joseph Valentino, University of Kentucky
The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects enrolled in the study will be placed in one of twelve treatment arms. Subjects in each of the twelve treatment regimens will receive either varenicline or bupropion or long-acting nicotine replacement therapy, with or without use of supplemental nicotine replacement therapy, and in combination with either standard of care smoking cessation counseling or high intensity/motivational smoking cessation counseling.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters Medical Center
      • Elizabethtown, Kentucky, United States, 42701
        • Hardin Memorial Health Cancer Care Center
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
      • Hazard, Kentucky, United States, 41701
        • ARH Cancer Center
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, Markey Cancer Center
      • Lexington, Kentucky, United States, 40502
        • Lexington Veterans Affair Medical Center
      • Louisville, Kentucky, United States, 40202
        • University of Louisville, James Graham Brown Cancer Center
      • Morehead, Kentucky, United States, 40351
        • St. Claire Regional Medical Center
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Health
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be ≥ 18 years of age.

  • Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:

    1. Lung or Bronchus cancer or Head & Neck, cancers (all sites).
    2. Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
    3. Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies [laser ablation,cervical conization, LEEP].
  • Having smoked at least 1 cigarette within 4 weeks of study enrollment.
  • Having at least a 10-pack year history of cigarette smoking.
  • Having smoked at least one cigarette within 1 month of cancer diagnosis.
  • Life expectancy is greater than 1 year.
  • Patient has an AUDIT score of < 10.
  • Patient has ECOG Performance Status of <=2.
  • Patients must have the ability to understand and the willingness to provide signed written informed consent document.

Exclusion Criteria:

  • Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
  • History of suicide attempt or preparation for attempt within the past 10 years.

  • C-SRSS Baseline/Screening:

    1. Patient response of "Yes" to any question except question 1.
    2. Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
  • Hospitalized for psychiatric illness within the past two years.
  • History of Bipolar disorder.
  • Currently taking Bupropion for depression.
  • Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
  • History of eating disorder such as anorexia or bulimia.
  • Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
  • History of epilepsy or seizure disorder.
  • Active severe kidney or liver disease.
  • Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
  • Patients within three months of a myocardial infarction.
  • Patients with unstable angina or serious arrhythmia.
  • Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
  • Patient taking varenicline or bupropion within one month of study enrollment.
  • Participation in any other investigational drug study within 4 weeks of study enrollment.
  • Currently enrolled in other professional tobacco cessation therapeutic intervention.
  • Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Intensity Counseling + Long Acting NRT + PRN NRT
Drug: High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + Long Acting NRT + PRN NRT
Experimental: High Intensity Counseling + bupropion + PRN NRT
Drug: High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + bupropion + PRN NRT
Experimental: High Intensity Counseling + varenicline + PRN NRT
Drug: High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + varenicline + PRN NRT
Experimental: High Intensity Counseling + Long Acting NRT
Drug: High Intensity Counseling + Long Acting NRT
High Intensity Counseling + Long Acting NRT
Experimental: High Intensity Counseling + bupropion
Drug: High Intensity Counseling + bupropion
High Intensity Counseling + bupropion
Experimental: High Intensity Counseling + varenicline
Drug: High Intensity Counseling + varenicline
High Intensity Counseling + varenicline
Experimental: Low Intensity Counseling + Long Acting NRT + PRN NRT
Drug: Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + Long Acting NRT + PRN NRT
Experimental: Low Intensity Counseling + bupropion + PRN NRT
Drug: Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT
Experimental: Low Intensity Counseling + varenicline + PRN NRT
Drug: Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT
Experimental: Low Intensity Counseling + Long Acting NRT
Drug: Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + Long Acting NRT
Experimental: Low Intensity Counseling + bupropion
Drug: Low Intensity Counseling + bupropion
Low Intensity Counseling + bupropion
Experimental: Low Intensity Counseling + varenicline
Drug: Low Intensity Counseling + varenicline
Low Intensity Counseling + varenicline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cigarette use
Time Frame: 8 weeks
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kentucky

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kentucky Lung Cancer Research Program

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph Valentino, M.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-13-MULTI-13-KCTN-1301
  • KCTN-1301 (Other Identifier: Markey Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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