Breast CancerNCT01532232
Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)
An observational study of Breast Cancer and Tobacco Dependence, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Tobacco Dependence
- What is being tested?
- varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSK breast clinic
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Breast Cancer, Tobacco Dependence
- Being tested
- placebo, varenicline
- Keywords
- PLACEBO, VARENICLINE (CHANTIX), Self-reported cigarettes smokers, Smoking Cessation, 11-136
- Medical subject headings
- Breast Neoplasms, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
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.
vareniclineDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
examine baseline factors that are associated with poor treatment response
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
Measured: 2 years
tolerability of and adherence
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
Measured: 2 years
rates of surgical complications
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532232
- Sponsor's protocol ID
- 11-136
- Status last verified
- Dec 2015
- First submitted
- 9 Feb 2012
- Last updated
- 23 Dec 2015
- Results posted
- No
Publications
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.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)
- ClinicalTrials.gov ID
- NCT01532232
- Acronym / sponsor ID
- 11-136
- Conditions
- Breast Cancer, Tobacco Dependence
- Keywords
- PLACEBO, VARENICLINE (CHANTIX), Self-reported cigarettes smokers, Smoking Cessation, 11-136
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | – | Drug: placeboThis 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. |
| varenicline | – | Drug: vareniclineThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSK breast clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboPts 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 | placebo |
| vareniclinePts 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 |
Primary outcome
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.
3 secondary outcomes
examine baseline factors that are associated with poor treatment response
Time frame: 2 years
tolerability of and adherence
Time frame: 2 years
rates of surgical complications
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Derived from this study: PubMed 37142273Livingstone-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.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Ostroff, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Tobacco Dependence, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01532232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.