Nicotine Cessation for Breast Cancer

Overseen By Judy Walsh

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Bmi > 35, Inflammatory breast cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a nicotine cessation program for women with breast cancer who continue to use nicotine products. Smoking or using nicotine can worsen cancer outcomes and increase surgical risks, so quitting could improve health and surgical options. The program helps women stop using nicotine, particularly those recommended for reconstructive surgery. Women with breast cancer (Stage 0-3) who use nicotine products and are considering reconstructive surgery might be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to important research that could enhance treatment options for women with breast cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nicotine cessation, so it's best to discuss your medications with the trial team.

What prior data suggests that this nicotine cessation program is safe for breast cancer patients?

Research has shown that programs designed to help people stop smoking are safe and effective for those with cancer. One study found that nearly half of the cancer patients who participated in a comprehensive tobacco treatment program quit smoking within nine months. This indicates that the program is both effective and manageable for participants. No serious adverse reactions have been reported in these programs.

Quitting smoking also improves health, helping individuals live longer and reducing the risk of smoking-related diseases. Therefore, joining a program to quit smoking can not only aid in cessation but also enhance overall health safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nicotine cessation program for breast cancer patients because it targets a crucial lifestyle factor that can impact cancer outcomes. Unlike traditional treatments for nicotine addiction, such as nicotine replacement therapies or medications like varenicline, this program is designed specifically for individuals with breast cancer. It aims to improve overall health and potentially enhance treatment effectiveness by focusing on quitting nicotine, which can otherwise compromise recovery and health. This personalized approach could make a significant difference in the quality of life and treatment success for breast cancer patients who smoke.

What evidence suggests that this nicotine cessation program is effective for breast cancer patients?

Research has shown that quitting smoking can help breast cancer patients live longer, regardless of their tumor stage. This trial will evaluate a nicotine cessation program designed to support smoking cessation. Studies have found that participating in a smoking cessation program can improve survival chances for cancer patients who smoke. Even stopping smoking for a few months can enhance survival rates. Additionally, quitting smoking can improve the effectiveness of cancer treatments and reduce the risk of treatment-related complications. Overall, stopping nicotine use greatly benefits breast cancer patients, especially those considering reconstructive surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Jennifer Fieber, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for women aged 18-75 with Stage 0-3 breast cancer who use nicotine products and are recommended to have reconstruction after mastectomy or oncoplastics after lumpectomy. They must have used nicotine within the past month and agree to follow study procedures.

Inclusion Criteria

I have been diagnosed with Stage 0 to 3 breast cancer.

Participants actively using nicotine products within the past month

Participant agrees to comply with all study-related procedures

Exclusion Criteria

Patients unable to complete sessions due to language, travel, or technology barriers

Patients already actively participating in another cessation program

Prisoners or involuntarily incarcerated individuals, or those compulsorily detained for treatment of psychiatric or physical illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nicotine Cessation Program

Participants undergo a nicotine cessation program designed by AHEC to evaluate feasibility, acceptability, and preliminary efficacy

12-24 weeks (if receiving neoadjuvant therapy) or 4-6 weeks (if not receiving neoadjuvant therapy)

Multiple program sessions

Surgical Procedure

Participants undergo reconstructive or oncoplastic surgery following completion of the nicotine cessation program

At surgery

Follow-up

Participants are monitored for the long-term impact on nicotine cessation and surgical outcomes

12 months postoperatively

Surveys and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine cessation program

Trial Overview The trial tests a formal nicotine cessation program by AHEC for its acceptability and preliminary effectiveness in helping women quit nicotine before reconstructive or oncoplastic breast surgery.

How Is the Trial Designed?

Group I: Nicotine cessation program Experimental Treatment 1 Intervention

Nicotine cessation program is already approved in United States, European Union for the following indications:

Approved in United States as Nicotine cessation program for:

• Preoperative nicotine cessation for breast cancer patients recommended for reconstruction

Approved in European Union as Nicotine cessation program for:

• Preoperative nicotine cessation for breast cancer patients recommended for reconstruction

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Tobacco use is a significant risk factor for cancer and negatively impacts cancer prognosis, yet effective cessation treatments are underutilized in oncology settings.

Implementing a comprehensive tobacco treatment program, which includes automatic referrals, motivational interviewing, and combined behavioral and pharmacological interventions, can significantly enhance smoking cessation success and improve health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Cessation in Oncology Care. Kaiser, EG., Prochaska, JJ., Kendra, MS.[2023]

Nicotine replacement therapies, such as nicotine polacrilex and transdermal patches, are generally safe with very rare major adverse effects, making them a viable option for smoking cessation.

These therapies can double long-term abstinence rates, particularly benefiting highly dependent smokers, and produce lower nicotine levels than cigarettes without harmful tar and carbon monoxide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-benefit assessment of nicotine preparations in smoking cessation. Hughes, JR.[2020]

In a study of 194 cancer patients referred to a tobacco cessation program, 47.9% accepted the referral, and among those, 25.8% successfully quit smoking, highlighting the program's potential effectiveness in supporting cancer patients in quitting tobacco.

Factors such as marital status and race influenced patients' acceptance of the referral, with single and Caucasian patients being less likely to engage, indicating the need for tailored approaches to improve participation in cessation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement and outcomes of cancer patients referred to a tobacco cessation program at a National Cancer Institute-designated cancer center. Westergaard, SA., Rupji, M., Franklin, LE., et al.[2023]

In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.

Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

A study of 160 smokers or recent quitters with lung or head and neck cancer found that while 86% received advice to quit smoking, only 65% were offered assistance, highlighting a gap in the provision of smoking cessation support.

Despite receiving advice, only about 50% of smokers expressed interest in smoking-cessation programs, indicating a need for innovative strategies to engage this population in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported receipt of and interest in smoking-cessation interventions after a diagnosis of cancer. Cooley, ME., Emmons, KM., Haddad, R., et al.[2022]

Nicotine replacement therapy (NRT) is safe and effective, but it is often used incorrectly; providing clear instructions and adequate dosing is crucial for maximizing its benefits.

Combining different forms of NRT, such as using a nicotine patch with gum or lozenges, and starting the patch two weeks before quitting can significantly improve quit rates and help prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising nicotine replacement therapy in clinical practice. Mendelsohn, C.[2018]

The Princess Margaret Cancer Centre successfully implemented a digitally-based smoking cessation program, screening 62% of new patients and identifying 10% as current smokers, which highlights the program's effectiveness in reaching a large patient population.

Of the smokers and recent quitters, 20% accepted referrals to smoking cessation counseling, demonstrating the program's potential to integrate smoking cessation services into cancer care and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive smoking cessation program in cancer care. Abdelmutti, N., Brual, J., Papadakos, J., et al.[2020]

Nicotine replacement therapies (like patches and gum) are considered relatively safe and effective aids for smoking cessation, as they provide a lower systemic nicotine load compared to active smoking.

Despite nicotine's potential health risks, the short-term use of nicotine replacement therapies is generally safer than smoking, which exposes users to thousands of harmful substances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are nicotine replacement strategies to facilitate smoking cessation safe? Lavelle, C., Birek, C., Scott, DA.[2017]

A meta-analysis of 28 studies found that nicotine replacement therapy (NRT) is associated with significant oral side effects, including mouth or throat irritation, oral soreness, and gastric reflux or vomiting, which can lead to treatment discontinuation.

Patients using NRT should be aware of these potential oral health issues and are advised to maintain regular dental check-ups and monitor their oral health before starting NRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral side effects of locally delivered nicotine replacement therapy: A meta-analysis of randomized controlled trials. Sivaramakrishnan, G., Alsobaiei, M., Sridharan, K.[2023]

Smoking significantly affects cancer patients' survival and treatment outcomes, highlighting the need for informed patient choices regarding smoking cessation.

Effective smoking cessation support, including nicotine replacement therapy, can help manage withdrawal symptoms and encourage cancer patients to quit smoking, ultimately improving their overall care and treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking care of smoker cancer patients: a review and some recommendations. Mazza, R., Lina, M., Boffi, R., et al.[2020]

In a study of 2126 breast cancer patients who were smokers at diagnosis, those who quit smoking showed a significantly improved survival rate, with a hazard ratio of 0.593, indicating they were more likely to be alive without disease compared to those who continued smoking.

The findings suggest that implementing smoking cessation programs early in the treatment process for breast cancer patients can enhance survival outcomes, highlighting the importance of addressing smoking habits in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Treatment for Smoking on Breast Cancer Patients' Survival. Singareeka Raghavendra, A., Kypriotakis, G., Karam-Hage, M., et al.[2022]

A randomized controlled trial involving 137 cancer patients found that a motivational interviewing intervention did not significantly increase smoking cessation rates compared to usual care, with both groups showing low quit rates at 6 months (5% for intervention vs. 6% for control).

However, a sensitivity analysis suggested that the intervention group had a higher quit rate (29%) compared to the control group (18%), indicating that while the intervention may not have been statistically significant, it could still have potential benefits that warrant further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Wakefield, M., Olver, I., Whitford, H., et al.[2022]

Nicotine addiction shares similar behavioral and pharmacological mechanisms with other addictive substances, making it a challenging condition to treat.

Nicotine replacement therapy is the most effective method for helping dependent smokers quit, but it requires careful management of dosage and duration, along with ongoing support from various healthcare providers to prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy and smoking cessation: what choice for its status?]. Lagrue, G.[2015]

In a study of 7,841 female smokers, those diagnosed with cancer had a 31% higher likelihood of quitting smoking compared to cancer-free women, indicating that a cancer diagnosis can motivate smoking cessation.

Cancer survivors who stopped smoking had a 36% lower risk of mortality compared to those who continued smoking, highlighting significant survival benefits from quitting after a cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation prolongs survival in female cancer survivors - the Danish nurse cohort. Heberg, J., Simonsen, MK., Thomsen, T., et al.[2020]

Citations

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The Impact of Treatment for Smoking on Breast Cancer ... Our study shows that quitting smoking is associated with improved survival among breast cancer patients who smoke across all tumor stages.

2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2825372

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Survival Outcomes of an Early Intervention Smoking ... Data also demonstrated that smoking cessation, regardless of time of entry, was associated with improved survival: abstinence at 3 months, 6 ...

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Tobacco Dependence in Breast Cancer Patients Trial of ... 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 ...

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The effect of a smoking cessation program for patients in ... Background: Compared to non-smokers, smokers have reduced effects of cancer treatment, and increased risk of treatment-related toxicity. Quitting smoking ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524003280

Determinants of persistent smoking among breast cancer ... Women with breast cancer have a higher relative 5-year survival rate (88% in 2020) (Robert Koch Institute, 2023) compared to those with cancers such as lung ...

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Study shows nearly half of cancer patients who enter a ... At three, six and nine-month follow-ups, smoking abstinence rates averaged 45%, 46% and 44%, respectively. Based on the program's success, the ...

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Adult Smoking Cessation — United States, 2022 | MMWR Quitting smoking reduces the risk for premature death and smoking-related diseases (1). Tobacco dependence is a chronic, relapsing condition ...