Quit nicotine, get reconstruction: new study offers hope for breast cancer patients
NCT ID NCT06461650
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a nicotine cessation program can help women with breast cancer quit nicotine before reconstructive surgery. About 20 women who use nicotine and are scheduled for mastectomy or lumpectomy with reconstruction will take part. The program includes up to four counseling sessions over several weeks, and some may also use nicotine replacement therapy. The goal is to see if the program is feasible and acceptable, and whether it helps women become eligible for surgery that could improve their outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nicotine cessation program (behavioral intervention)
- What this could lead to
- If successful, this program could help women quit nicotine before surgery, making them eligible for breast reconstruction and potentially reducing surgical complications.
- What could go wrong
- This is a very small feasibility study with only 20 participants, so results may not apply widely. The program's success depends on participants' motivation, and nicotine replacement therapy must be stopped before surgery, which may be challenging.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults ≥ 18 years of age and ≤ 80 years of age. * Women who are diagnosed with Stage 0 - 3 breast cancer confirmed by biopsy * Women who have been recommended to have reconstruction at time of mastectomy or oncoplastics at time of lumpectomy * Participants who actively use nicotine products defined as any self-reported nicotine use within the past month * Participant agrees to comply with all the study-related procedures. Exclusion Criteria: * Patients not eligible for reconstruction or oncoplastics for other reasons including BMI\>35 or inflammatory breast cancer or based on surgeon discretion. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness. * Patients unable to complete the sessions because of language, travel or technology barriers * Patients already actively participating in another cessation program * Patients who are pregnant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
RECRUITINGGainesville, Florida, 32608, United States
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