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

NCT01532232

Last updated date
Study Location
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Tobacco Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Breast Cancer, Tobacco DependenceTobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)
NCT01532232
  1. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)
Official Title Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
saliva samples
Sampling Method Probability Sample
Study Population MSK breast clinic
Condition
  • Breast Cancer
  • Tobacco Dependence
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • 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.
    Intervention: Drug: placebo
  • 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.
    Intervention: Drug: varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 14, 2015)
7
Original Estimated Enrollment
 (submitted: February 13, 2012)
100
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01532232
Other Study ID Numbers 11-136
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Pfizer
Investigators
Principal Investigator:Jamie Ostroff, PhDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2015