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

Trial Summary

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 data supports the effectiveness of this treatment for nicotine cessation in breast cancer patients?

Research shows that quitting smoking can improve survival rates for cancer patients, including those with breast cancer. Effective treatments, like nicotine replacement therapy and motivational interviewing, help people stop smoking and can lead to better health outcomes for cancer patients. ^{1 2 3 4 5}

Is nicotine replacement therapy safe for humans?

Nicotine replacement therapy (NRT) is generally considered safe for humans and is used to help people quit smoking. It delivers lower nicotine levels than smoking and is usually used for a short time. Major side effects are rare, but some people may experience mild oral side effects. ^{6 7 8 9 10}

How is the nicotine cessation treatment for breast cancer unique compared to other treatments?

The nicotine cessation treatment for breast cancer is unique because it combines behavioral support with nicotine replacement therapy, which is tailored to the individual's level of nicotine dependence and includes systematic follow-up to prevent relapse. This comprehensive approach is not commonly integrated into standard cancer care, making it a novel addition to improve outcomes for cancer patients who smoke. ^{5 11 12 13 14}

What is the purpose of this trial?

Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Nicotine cessation is rarely addressed in breast cancer patients at the time of diagnosis and may be a missed opportunity to optimize patient outcomes. Patients that use nicotine products are not offered reconstruction at time of mastectomy or oncoplastics at the time of lumpectomy, which can be emotionally distressing in women with breast cancer. Reconstruction could be an additional motivating factor in nicotine cessation success. This study aims to evaluate the feasibility of a nicotine cessation program designed by Area Health Education Center (AHEC) in the target population. The study is designed to test the acceptability, and preliminary efficacy of a formal nicotine cessation program in women actively using nicotine products with breast cancer recommended for reconstructive or oncoplastics surgery.

Research Team

Jennifer Fieber, MD

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

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]

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 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]

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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Smoking cessation prolongs survival in female cancer survivors - the Danish nurse cohort. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Taking care of smoker cancer patients: a review and some recommendations. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Treatment for Smoking on Breast Cancer Patients' Survival. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Tobacco Cessation in Oncology Care. [2023]

6. Australia pubmed.ncbi.nlm.nih.gov

Optimising nicotine replacement therapy in clinical practice. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. Canada pubmed.ncbi.nlm.nih.gov

Are nicotine replacement strategies to facilitate smoking cessation safe? [2017]

9. England pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Oral side effects of locally delivered nicotine replacement therapy: A meta-analysis of randomized controlled trials. [2023]

11. United States 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Patient-reported receipt of and interest in smoking-cessation interventions after a diagnosis of cancer. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

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

14. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive smoking cessation program in cancer care. [2020]