208 Participants Needed

E-cigarettes for Cancer Patients Who Smoke

(CARE Trial)

RC
CM
Overseen ByChloe Morone
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist cancer patients who smoke by testing whether switching from cigarettes to e-cigarettes (electronic cigarettes) offers a better option. It specifically targets those who refuse traditional smoking cessation programs. Participants will either try e-cigarettes or receive standard tobacco treatment referrals. This trial may suit individuals who have smoked recently, are over 21, speak English, and have not used e-cigarettes in the past 30 days. As an unphased trial, it provides a unique opportunity for participants to explore alternative smoking cessation methods tailored to their needs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using any smoking cessation medications or programs.

What prior data suggests that e-cigarette switching is safe for cancer patients who smoke?

Research has shown that e-cigarettes are generally safer than regular cigarettes. Many studies indicate that vaping is less harmful because e-cigarettes do not contain tobacco, which causes cancer. Specifically, people who use e-cigarettes have a much lower cancer rate compared to those who smoke regular cigarettes—2.3% versus 16.8%.

However, e-cigarettes are not completely risk-free. Some research suggests that they can still expose users to chemicals linked to cancer and other health issues like heart and lung problems. Despite these concerns, e-cigarettes have helped more people quit smoking when used with standard counseling.

Overall, e-cigarettes appear to be a better choice than smoking regular cigarettes, but they do carry some risks.12345

Why are researchers excited about this trial?

Unlike the standard smoking cessation treatments, which often involve nicotine replacement therapies or medications, e-cigarette switching offers a potentially less harmful alternative by mimicking the act of smoking without burning tobacco. Researchers are excited about e-cigarettes because they deliver nicotine in vapor form, reducing exposure to harmful chemicals found in cigarette smoke. Additionally, the transition to e-cigarettes might be more appealing for smokers who struggle with quitting entirely, as it maintains the hand-to-mouth action of smoking. This approach could represent a significant step forward in harm reduction for cancer patients who smoke, offering them a more feasible pathway to reduce smoking-related health risks.

What evidence suggests that e-cigarette switching is effective for cancer patients who smoke?

Research has shown that switching from smoking to e-cigarettes can help people quit smoking. In this trial, participants in the Harm Reduction arm will receive an e-cigarette and attempt to switch completely from smoking to using the e-cigarette. One study found that using e-cigarettes along with regular quit-smoking support helped more people stop using tobacco. Many reports indicate that e-cigarettes are much less harmful than regular cigarettes because they don't contain tobacco, which can cause cancer. However, people who use both cigarettes and e-cigarettes might have a higher risk of lung cancer than those who only smoke cigarettes. Overall, e-cigarettes could be a safer choice for smokers, especially for those who find it hard to quit smoking completely.45678

Who Is on the Research Team?

AR

Alana Rojewski

Principal Investigator

Medical University of South Carolina

TS

Tracy Smith

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adult cancer patients (21+) who currently smoke, as noted in their medical records and self-reported within the last 30 days. Participants must speak English and have refused traditional tobacco treatment options offered by the healthcare center.

Inclusion Criteria

I speak English.
I am 21 years old or older.
I am currently a smoker, as noted in my medical records and by my own admission.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (virtual)

Baseline Assessment

Participants complete baseline assessments, including breath CO and blood draw for biomarker assessment

1 week
1 visit (in-person)

Treatment

Participants in the Switch group receive a 13-week supply of e-cigarettes and choose a switch date. Assessments are completed every 2 weeks through the end of product provision

13 weeks
6 visits (virtual)

Follow-up

Participants complete assessments and blood draws at Week 24 to evaluate the impact of switching to e-cigarettes

12 weeks
1 visit (in-person), 1 visit (virtual)

Interviews

Semi-structured interviews with participants and providers to gain in-depth understanding of intervention experiences

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • E-cigarette switching
Trial Overview The study examines if switching from cigarettes to e-cigarettes reduces harm among oncology outpatients who reject standard tobacco treatments. It's a type 1 hybrid effectiveness-implementation trial with participants randomly assigned to either continue smoking or switch to e-cigarettes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Harm Reduction (E-cigarette switching)Experimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Electronic cigarette use patterns and reasons for ...One in five smokers with cancer report current e‐cigarette use, but most are not using e‐cigarettes daily. The majority report using e‐cigarettes to quit ...
Electronic Nicotine-Delivery Systems for Smoking CessationThe addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking ...
E-cigarettes and Vaping | Health Risks of E- ...Recent research indicates that people who use both cigarettes and e-cigarettes have a higher risk of getting lung cancer than people who only use cigarettes.
Comparative effects of combustible cigarette versus ...Smoking drives ∼90 % of lung cancer cases, with heavy smokers (>30 pack-years) having a 10-30 times greater risk than non-smokers [2,3]. Non-small cell lung ...
Is vaping harmful? | Vaping side effectsMany studies show that vaping is far less harmful than smoking. This is because e-cigarettes don't contain cancer-causing tobacco.
Cancer Prevalence in E-Cigarette Users: A Retrospective ...The e-cigarette users have lower prevalence of cancer compared to traditional smoking (2.3% vs. 16.8%; P < 0.0001), but they were diagnosed with cancer at a ...
Evidence update on the cancer risk of vaping e-cigarettesThere is substantial evidence that e-cigarette exposure is associated with biomarkers reflective of cancer disease risk.
Dual-Use of Cigarettes and E-Cigarettes Exposes Adults to ...This exposure indicates potential for cancer, cardiovascular, reproductive/developmental, and respiratory harms. The findings are out today in ...
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