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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01532232
First received: February 9, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Tobacco Dependence
Drug: placebo
Drug: varenicline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • examine baseline factors that are associated with poor treatment response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • tolerability of and adherence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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

  • rates of surgical complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Experimental: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532232

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Pfizer
Investigators
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01532232     History of Changes
Other Study ID Numbers: 11-136
Study First Received: February 9, 2012
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PLACEBO
VARENICLINE (CHANTIX)
Self-reported cigarettes smokers
Smoking Cessation
11-136

Additional relevant MeSH terms:
Breast Neoplasms
Tobacco Use Disorder
Breast Diseases
Chemically-Induced Disorders
Mental Disorders
Neoplasms
Neoplasms by Site
Skin Diseases
Substance-Related Disorders
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014