E-Cigarettes for Smokers at High Risk for Lung Cancer

Overseen By Jason Robinson, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Depression, Lung cancer, Uncontrolled conditions, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Information gained from this trial may help inform regulators of the potential risks and benefits of switching smokers at high risk for lung cancer to electronic cigarettes. This research also may help inform the Food and Drug Administration (FDA) how best to regulate e-cigarettes with the goal of improving public health.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment e-cigarettes for smokers at high risk for lung cancer?

Some studies suggest that e-cigarettes may reduce harm compared to smoking traditional cigarettes, but there is no definitive evidence supporting their effectiveness as a smoking cessation aid. The World Health Organization does not endorse e-cigarettes for quitting smoking, and they may actually reduce smoking cessation rates among current smokers. ^{1 2 3 4 5}

Are e-cigarettes safe for human use?

E-cigarettes expose users to potentially harmful chemicals and have been linked to severe lung diseases, nicotine poisoning, and other health risks. Long-term safety is unknown, and they are not endorsed as a safe alternative to smoking by health organizations. ^{3 6 7 8 9}

How is the treatment using e-cigarettes for smokers at high risk for lung cancer different from other treatments?

This treatment is unique because it involves smokers switching from traditional cigarettes to e-cigarettes, which are battery-powered devices that heat a liquid to create a vapor for inhalation. Unlike other smoking cessation methods, e-cigarettes may still expose users to nicotine and other chemicals, and their long-term health effects are not fully understood. ^{1 2 6 10 11}

Research Team

Jason Robinson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for older adult smokers aged 50-80 with a significant smoking history who are at high risk for lung cancer and interested in trying electronic cigarettes (e-cigarettes) to change their smoking habits. They must speak and write English, be able to receive mail, comply with COVID-19 policies, and agree to biospecimen collection. Pregnant women or those not using effective birth control are excluded.

Inclusion Criteria

Have an address where he/she can receive mail

Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit

Willing to have biospecimen samples taken, either in-home using a mobile phlebotomy service, or at an approved collection site

Exclusion Criteria

I do not have any cognitive issues that would stop me from reliably participating in the study.

I am not pregnant, breastfeeding, or at risk of becoming pregnant because I use effective birth control.

Unwilling to consent for blood draw

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch from combustible cigarettes to e-cigarettes and are monitored for product use, acceptability, and reinforcement

26 weeks

Visits at 0, 1, 6, 7, 12, 13, 26, and 27 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nicotine Replacement
• Participants smoke their usual brand of cigarettes for 26 weeks.
• Participants will vape electronic cigarettes for 26 weeks.
• Questionnaire Administration

Trial Overview The study compares the health effects of continuing traditional cigarette smoking versus switching to e-cigarettes over a period of 26 weeks. Participants will also complete questionnaires and may use nicotine replacement therapies. The goal is to inform FDA regulations on e-cigarettes.

Participant Groups

Group I: E-Cigarettes Experimental Treatment 4 Interventions

Participants vape e-cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day for up to 182 days. Participants complete questionnaires over 50 minutes and undergo collection of urine sample at 0, 1, 7, 13, and 27 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Among 1529 cancer survivors who reported ever using e-cigarettes, 76.7% were not active users, indicating that most do not regularly use e-cigarettes despite having tried them.

Active e-cigarette usage was more common among former or current traditional cigarette smokers, suggesting that e-cigarettes may be more appealing to those with a history of smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in frequency of e-cigarette use among cancer patients and survivors in the United States, 2014-2018. Dewar, EO., Dee, EC., Arega, MA., et al.[2021]

E-cigarettes can increase the risk of nicotine dependence and may lead to higher rates of combustible tobacco use, indicating a potential gateway effect for users.

While some studies suggest that e-cigarettes may be less harmful than traditional smoking, the combination of e-cigarette and cigarette use appears to be more detrimental to health than using either product alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Cigarette Use, Misuse, and Harm. Kathuria, H.[2022]

E-cigarettes have entered the market without the extensive safety testing required for traditional medical products, leading to significant health risks such as lung diseases, nicotine poisoning, and even injuries from product explosions.

Contrary to their intended purpose, e-cigarettes are linked to lower smoking cessation rates and higher relapse rates among former smokers, prompting the World Health Organization to advise against their use as cessation aids and recommend counseling for those dependent on them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms of Electronic Cigarettes: What the Healthcare Provider Needs to Know. Farber, HJ., Conrado Pacheco Gallego, M., Galiatsatos, P., et al.[2021]

Smokers are increasingly using e-cigarettes or electronic nicotine delivery systems (ENDS) as alternatives to traditional combustible tobacco products like cigarettes and cigars.

E-cigarettes are often seen as a tool for smoking cessation, providing a different method for nicotine delivery compared to conventional smoking methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of E-Cigarettes and Vaping. [2020]

Electronic nicotine delivery systems (ENDS), like e-cigarettes, are increasingly popular but their overall health impacts are still unclear, necessitating further research to understand their role in smoking cessation and potential risks, especially for youth.

The American Association for Cancer Research and the American Society of Clinical Oncology recommend strict regulations on ENDS, including ingredient transparency, childproof packaging, and restrictions on marketing to youth, to mitigate potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. Brandon, TH., Goniewicz, ML., Hanna, NH., et al.[2022]

A 17-year-old male developed severe respiratory issues, including acute bronchiolitis and chronic airflow obstruction, after intensive vaping of flavored e-liquids, suggesting a potential link to bronchiolitis obliterans, also known as 'popcorn lung'.

Despite treatment with high-dose corticosteroids and mechanical ventilation, the patient experienced lasting pulmonary function impairment, highlighting the serious and possibly long-term health risks associated with vaping, which necessitates further research and regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth. Landman, ST., Dhaliwal, I., Mackenzie, CA., et al.[2023]

After four years of follow-up, e-cigarette users showed a 63.6% rate of tobacco abstinence, indicating that switching to e-cigarettes may help some smokers quit, but overall harm reduction was minimal and not statistically significant.

Dual users of e-cigarettes and tobacco did not show improved cessation rates compared to exclusive tobacco smokers, suggesting that using both may not enhance the likelihood of quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cohort study of electronic cigarette use: safety and effectiveness after 4 years of follow-up. Flacco, ME., Ferrante, M., Fiore, M., et al.[2020]

In a study using two validated in vitro models, e-cigarette vapor extracts from three popular brands did not show significant increases in mutations in either mouse or human cells, suggesting limited mutagenic effects.

The research indicates that, at the concentrations tested, e-cig vapor may not pose a significant risk of inducing genetic mutations, which is important for understanding the potential carcinogenic effects of e-cigarette use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited mutagenicity of electronic cigarettes in mouse or human cells in vitro. Tommasi, S., Bates, SE., Behar, RZ., et al.[2018]

E-cigarettes are generally considered less harmful than traditional cigarettes, but there is limited data quantifying their relative risks and long-term effects on human health.

Recent studies indicate that e-cigarettes can negatively impact lung and cardiovascular health, highlighting the need for more research on their safety and long-term consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What we know from the harmful effects of e-cigarettes?] Nagy, LB.[2020]

In a study of 520 adult smokers, those who used e-cigarettes to reduce cigarette consumption reported significantly lower dependence on cigarettes compared to those using a cigarette substitute, indicating that e-cigarettes may help in reducing cigarette dependence.

While e-cigarette use led to increased dependence on e-cigarettes, particularly in the high-nicotine group, there was no significant increase in overall nicotine exposure, suggesting that e-cigarettes can be a safer alternative for reducing traditional cigarette use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Nicotine Dependence Among Smokers Using Electronic Cigarettes to Reduce Cigarette Smoking in a Randomized Controlled Trial. Yingst, J., Wang, X., Lopez, AA., et al.[2023]

This 5-year multicentric study aims to evaluate the effectiveness of e-cigarettes in helping smokers quit traditional cigarettes, involving 1500 participants divided into three groups: e-cigarette users, traditional cigarette smokers, and mixed users.

The study will assess both short- and long-term adherence to e-cigarettes, their health effects compared to traditional smoking, and track various health outcomes, including hospital admissions for serious diseases, providing crucial data for future guidelines on e-cigarette use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology. Manzoli, L., La Vecchia, C., Flacco, ME., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Trends in frequency of e-cigarette use among cancer patients and survivors in the United States, 2014-2018. [2021]

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

Electronic Cigarette Use, Misuse, and Harm. [2022]

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

Harms of Electronic Cigarettes: What the Healthcare Provider Needs to Know. [2021]

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

Use of E-Cigarettes and Vaping. [2020]

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

Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Cohort study of electronic cigarette use: safety and effectiveness after 4 years of follow-up. [2020]

8. Ireland pubmed.ncbi.nlm.nih.gov

Limited mutagenicity of electronic cigarettes in mouse or human cells in vitro. [2018]

9. Hungary pubmed.ncbi.nlm.nih.gov

[What we know from the harmful effects of e-cigarettes?] [2020]

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

Changes in Nicotine Dependence Among Smokers Using Electronic Cigarettes to Reduce Cigarette Smoking in a Randomized Controlled Trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology. [2021]