Sponsor study identifier
observational
7
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 9, 2012
Actual (reported)February 14, 2012
Actual (reported)October 2014
Actual (reported)October 2014
Actual (reported)effectiveness
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
examine baseline factors that are associated with poor treatment response
2 years
tolerability of and adherence
2 years
rates of surgical complications
2 years
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.
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.
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.
MSK breast clinic
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
saliva samples
Jamie Ostroff, PhD
Memorial Sloan Kettering Cancer Center
7 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2012
First Posted
February 14, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Tailoring Varenicline to Individual Needs (TVIN Study)
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.
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Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
December 23, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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