E-Cigarettes for Smokers at High Risk for Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Depression, Lung cancer, Uncontrolled conditions, Pregnancy, others
No Placebo Group
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.
12345Are 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.
36789How 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.
1261011Eligibility 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
+5 more
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
+4 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: E-CigarettesExperimental Treatment4 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Loading ...
Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Trends in frequency of e-cigarette use among cancer patients and survivors in the United States, 2014-2018. [2021]Electronic cigarettes (e-cigarettes) have become increasingly popular in the United States, including among cancer survivors; however, the majority of prior studies do not report frequency of active e-cigarette usage.
Electronic Cigarette Use, Misuse, and Harm. [2022]Electronic cigarettes (e-cigarettes) are battery-powered devices that use heat to aerosolize a liquid containing a variety of substances (usually nicotine and/or cannabinoids, flavorings, and glycerol or propylene glycol base) that is then inhaled. E-cigarettes are rapidly evolving over time, so the true health effects of e-cigarettes are difficult to study and remain largely unknown. We review the effects of e-cigarettes on nicotine addiction and on pulmonary disease including the effects of dual use and switching from combustible cigarettes to e-cigarettes. Studies show that e-cigarette use can increase the risk to nicotine dependence and combustible tobacco use. Studies show an association between e-cigarette use and pulmonary disease. Some studies suggest reduced harm from e-cigarette use compared with smoking, but this requires further study. Most adults who use e-cigarettes also smoke cigarettes; epidemiologic studies suggest that the combination of e-cigarettes and cigarettes is more harmful than using either product alone.
Harms of Electronic Cigarettes: What the Healthcare Provider Needs to Know. [2021]Electronic cigarettes (e-cigarettes) reached the market without either extensive preclinical toxicology testing or long-term safety trials that would be required of conventional therapeutics or medical devices. E-cigarettes are considered a tobacco product and as such have no manufacturing quality or safety standards. A growing body of evidence documents severe harms from e-cigarette use, including injuries from product explosions, nicotine poisoning, and severe lung diseases. Commonly used e-cigarette components have significant inhalation toxicity. Emerging evidence from laboratory studies suggests substantial reason for concern for long-term harms, including risk for cardiovascular disease, chronic obstructive lung disease, and cancer. Rather than helping people stop smoking, e-cigarette use is associated with reduced rates of smoking cessation among current smokers and an increased risk of relapse to smoking among former smokers. The World Health Organization advises, "Unlike the tried and tested nicotine and non-nicotine pharmacotherapies that are known to help people quit tobacco use, WHO does not endorse e-cigarettes as cessation aids." Careful evaluation of all the available research justifies a strong recommendation that healthcare providers should neither prescribe nor recommend e-cigarettes for persons who are tobacco dependent. If a patient is dependent on e-cigarettes, the healthcare provider should provide counseling and treatment (of nicotine dependence) to help the patient to stop their e-cigarette use.
Use of E-Cigarettes and Vaping. [2020]Smokers who use combustible tobacco products, such as cigarettes, cigars, and pipes, have been turning to electronic cigarettes (e-cigarettes) or electronic nicotine delivery systems (ENDS) as an alternative to combustible tobacco products and as a smoking cessation tool. Use of e-cigarettes has been referred to as vaping, with numerous terms for these devices, such as vaporizers, vape pens, hookah pens, e-cigs, or e-pipes.
Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. [2022]Combustible tobacco use remains the number one preventable cause of disease, disability, and death in the United States. Electronic nicotine delivery systems (ENDS), which include e-cigarettes, are devices capable of delivering nicotine in an aerosolized form. ENDS use by both adults and youth has increased rapidly, and some have advocated these products could serve as harm-reduction devices and smoking cessation aids. ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or formers smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the public's health; however, definitive data are lacking. AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the FDA and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited.
Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth. [2023]Although electronic cigarettes (e-cigarettes) were initially marketed as a potential smoking-cessation aid and a safer alternative to smoking, the long-term health effect of e-cigarette use ("vaping") is unknown. Vaping e-liquids expose the user to several potentially harmful chemicals, including diacetyl, a flavouring compound known to cause bronchiolitis obliterans with inhalational exposure ("popcorn worker's lung").
Cohort study of electronic cigarette use: safety and effectiveness after 4 years of follow-up. [2020]More than a decade after e-cigarette (e-cig) market launch, limited information are available on their safety after 24 months of use. In 2013, we started the first observational study assessing e-cig long-term effectiveness and safety, directly comparing tobacco smokers and e-cig users. Here we report the results after four years of follow-up.
Limited mutagenicity of electronic cigarettes in mouse or human cells in vitro. [2018]Electronic cigarettes (e-cig), which are promoted as safe alternatives to tobacco cigarettes or as aides to smoking cessation, are becoming increasingly popular among adult chronic smokers and adolescents experimenting with tobacco products. Despite the known presence of toxicants and carcinogens in e-cig liquid and vapor, the possible carcinogenic effects of e-cig use in humans are unknown.
[What we know from the harmful effects of e-cigarettes?] [2020]Electronic cigarettes are becoming increasingly popular with smokers worldwide. This has created an entirely new public health dilemma. The central issue in the debate is the disease risk imposed by e-cigarettes. It is generally acknowledged that e-cigarettes are unlikely to be as harmful as conventional cigarettes, but there are little data that quantify their relative harms. Experiments in cell cultures and animal studies show that e-cigarettes can have multiple negative effects. Scientific evidence regarding their human acute health effects is limited. The long term effects in humans are unknown, and there is no evidence that e-cigarettes are safer than tobacco in the long term. This review higlights the recent data regarding e-cigarettes toxicity impact on lung and cardiovascular system. Orv Hetil. 2019; 160(45): 1767-1773.
Changes in Nicotine Dependence Among Smokers Using Electronic Cigarettes to Reduce Cigarette Smoking in a Randomized Controlled Trial. [2023]How nicotine dependence will be affected when current smokers initiate electronic cigarette (e-cigarette) use to reduce cigarette smoking is unknown. This study evaluated cigarette, e-cigarette, and total nicotine dependence more than 6 months among smokers reducing cigarette consumption by replacing with e-cigarettes.
Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology. [2021]While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety.We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking.