Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)

December 22, 2015 updated by: Memorial Sloan Kettering Cancer Center

Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)

Breast cancer patients who smoke, are at greater risk for treatment complications. The purpose of this study is to see if the researchers can find ways to help patients who have breast cancer quit smoking. They will compare two ways to help people quit smoking. Some patients will receive varenicline, a prescription medicine also known as Chantix,®. Other patients will receive a placebo drug. A placebo is an inactive substance that contains no medicine. All patients will receive smoking cessation counseling provided by our tobacco treatment specialists. They hope that what the researchers learn from this study will help us improve our smoking cessation treatment program for breast cancer patients.

Study Overview

Status

Status

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

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.

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.
Observational

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.
7

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
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer 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

Sampling Method

Probability Sample

Study Population

MSK breast clinic

Description

Inclusion Criteria:

  • MSK patients diagnosed with breast cancer or have a mass suspicious of breast cancer at the time of enrollment, as per clinician judgment or EMR;
  • Self-reported current cigarette smoker (defined as daily smoking in the past seven days)
  • Advised to quit smoking by their MSK physician and willing to receive smoking cessation counseling and treatment; as per self report
  • Fluent in English

Exclusion Criteria:

  • Patients less than 18 years of age because the safety and efficacy of varenicline have not yet been tested in children;
  • Evidence of any known or suspected medical contraindications for use of varenicline (e.g., recent (within past two months) cardiovascular instability (including myocardial infarction or unstable angina; uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, or severe congestive heart failure (New York Heart Association class III or IV), severe chronic obstructive pulmonary disease; uncontrolled gastrointestinal, hepatic, or endocrine disease; or severe renal impairment.
  • Self-reported evidence of significant psychiatric history (e.g., schizophrenia, unstable bipolar disorder, panic disorder, untreated major depression) sufficient, in the investigators' judgment, to preclude participation in the clinical trial;
  • Self-reported evidence of recent substance abuse or heavy alcohol use (> 14 drinks weekly) in the last 6 months;
  • Self-reported recent use (in the past 30 days) or planned use of nicotine replacement therapy (NRT) or other FDA approved cessation pharmacotherapy (bupropion);
  • Pre-menopausal women who are pregnant as per EMR
  • Women who are breast-feeding as per self-report.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
placebo
This is a randomized, double-blind, placebo-controlled trial comparing the effectiveness and tolerability of varenicline with placebo for smoking cessation in 30 tobacco dependent breast cancer patients.
Drug: placebo
Pts will receive the standard 12-week dosing regimen consisting of 1 mg po of study drug twice daily for 11 weeks,along with smoking cessation counseling, for 11 weeks with an initial dose titration to full strength during the 1st week as follows: 0.5 mg po once daily for 3 days titrated to 0.5mg po twice daily for 4 days. 154 pills will be supplied for the 12 week tx. In order to compensate for any accidentally dropped or lost pills during the study duration, a total of 175 pills will be given to the patient. Along with smoking cessation counseling, for 11 weeks. Pts will receive their medication from the MSK Pharmacy & equivalent dosing & side effect education from our Tobacco Cessation Nurse Practitioner. Tx with the study drug will begin after the initial counseling session. Physicians & tobacco cessation nurses will be blinded regarding pts' assignment to medication or placebo tx arm. Likewise, pts will not be informed as to which medication condition they have been assigned.
varenicline
This is a randomized, double-blind, placebo-controlled trial comparing the effectiveness and tolerability of varenicline with placebo for smoking cessation in 30 tobacco dependent breast cancer patients.
Drug: varenicline
Pts will receive the standard 12-week dosing regimen consisting of 1 mg po of study drug twice daily for 11 weeks,along with smoking cessation counseling, for 11 weeks with an initial dose titration to full strength during the 1st week as follows: 0.5 mg po once daily for 3 days titrated to 0.5mg po twice daily for 4 days. 154 pills will be supplied for the 12 week tx. In order to compensate for any accidentally dropped or lost pills during the study duration, a total of 175 pills will be given to the patient. Along with smoking cessation counseling, for 11 weeks. Pts will receive their medication from the MSK Pharmacy & equivalent dosing & side effect education from our Tobacco Cessation Nurse Practitioner. Tx with the study drug will begin after the initial counseling session. Physicians & tobacco cessation nurses will be blinded regarding pts' assignment to medication or placebo tx arm. Likewise, pts will not be informed as to which medication condition they have been assigned.

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
effectiveness
Time Frame: 2 years
To conduct a double-blind, randomized clinical trial to obtain pilot data on the the effectiveness of Intervention (varenicline and behavioral smoking cessation counseling) and Control (placebo and behavioral smoking cessation counseling) with regard to tobacco (smoking) cessation outcomes (point abstinence, continuous abstinence) in tobaccodependent breast cancer patients.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
examine baseline factors that are associated with poor treatment response
Time Frame: 2 years
To describe the association between baseline factors (i.e., demographic, smoking history and psychosocial) and poor cessation treatment response (i.e., persistent smoking, post-surgical smoking relapse
2 years
tolerability of and adherence
Time Frame: 2 years
Adherence to study medication will be assessed by summarizing the medication logs. Tolerability will be assessed by percent of patients who discontinue study medication due to side effects. Using CTCAE 4.0
2 years
rates of surgical complications
Time Frame: 2 years
among tobacco dependent breast cancer patients. We will primarily use descriptive statistics to summarize the rates of surgical complications among tobacco dependent breast cancer patients, as indicated by the prevalence of surgical complications (i.e., occurrence of infection, skin flap necrosis, reconstructive flap failure, seroma, and hematoma) documented in the patient's medical record.
2 years

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.
Memorial Sloan Kettering Cancer Center

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.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

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.
February 1, 2012

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.
October 1, 2014

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.
October 1, 2014

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).
February 9, 2012

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.
February 13, 2012

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.
February 14, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
December 23, 2015

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.
December 22, 2015

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.
December 1, 2015

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.
  • 11-136

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings