What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Targeted therapies, like erlotinib and gefitinib, may lead to skin rashes, diarrhea, and liver function abnormalities. Immunotherapy can result in immune-related side effects, including inflammation of the lungs (pneumonitis), liver (hepatitis), and other organs. The Enhanced Tobacco Intervention Protocol (ETIP) focuses on comprehensive support for smoking cessation, which can improve overall treatment outcomes and reduce the risk of complications from these therapies.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Non-Small Cell Lung Cancer (NSCLC). Notable approvals include erlotinib and gefitinib, which are EGFR tyrosine-kinase inhibitors used for patients with specific genetic mutations. Pembrolizumab, an immune checkpoint inhibitor, has been approved in combination with chemotherapy for advanced NSCLC, showing improved overall survival and progression-free survival. Atezolizumab, another immune checkpoint inhibitor, has been approved in combination with bevacizumab and chemotherapy for patients with advanced nonsquamous NSCLC. These treatments align with the comprehensive support approach of the Enhanced Tobacco Intervention Protocol (ETIP), which includes counseling, drug therapy, nicotine replacement, and follow-up to aid smoking cessation.

What other types of research exist?

Promising novel alternatives to ETIP for NSCLC patients include: 1) Mobile phone-based interventions and apps, which provide real-time monitoring and support; 2) Social network-based interventions like Tweet2Quit, which leverage peer support; 3) Internet-based interventions, offering structured programs and resources online; and 4) Integration of smoking cessation protocols into electronic medical records (eTobacco protocol) to streamline and enhance patient support.

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Smoking Cessation Program for Cancer

N/A

Waitlist Available

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients have smoked > 100 cigarettes in their lifetime and have smoked within the last 30 days

Subjects must read and speak fluent English

Must not have

Patients with psychiatric disorders with indications of current uncontrolled illness, or patients currently being treated on psychiatric medications

Patient who are hemodynamically or electrically unstable or have had orthopedic surgery or a serious fracture(s) within the past 6 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Summary

This trial studies how well a comprehensive smoking cessation program (ETIP) works in helping head and neck and lung cancer patients reduce cigarette use. ETIP includes personalized counseling, medication, nicotine patches or gum, and ongoing support. It aims to provide support, reduce cravings, and ease withdrawal symptoms.

Who is the study for?

This trial is for head and neck or lung cancer patients who are smokers, willing to quit, have a life expectancy of at least 6 months, speak English fluently, and are new patients at TJUH. Excluded are non-English speakers, those with allergies to NRT/bupropion/varenicline or severe skin reactions, unstable medical conditions, swallowing disorders, pregnant/breastfeeding women, certain medication users.

What is being tested?

The study compares an Enhanced Tobacco Intervention Protocol (ETIP) with standard treatment in helping cancer patients reduce smoking. ETIP includes personalized counseling (in-person/telehealth), drug therapy options like nicotine replacement and medications bupropion/varenicline plus regular follow-ups.

What are the potential side effects?

Possible side effects include allergic reactions to nicotine replacement or medications used (bupropion/varenicline), skin reactions like Steven's Johnson syndrome. Specific side effects from quitting smoking can also occur such as withdrawal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have smoked more than 100 cigarettes in my life and have smoked in the last 30 days.

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I can read and speak English fluently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently experiencing uncontrolled psychiatric illness nor am I on psychiatric medications.

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I haven't had major surgery, serious fractures, or heart issues in the last 6 weeks.

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I recently had a heart attack or have serious heart rhythm problems or chest pain.

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I cannot swallow pills due to a severe condition.

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I am able to understand and make decisions about my health care.

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I am currently taking anti-depressants.

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I am fluent in English.

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I haven't used nicotine or tobacco products for the required time before and after my surgery.

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I do not have a condition that increases my risk of seizures, such as a severe brain injury or eating disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Smoke

Secondary study objectives

Cigarette abstinence at 1 and 6 months, as reported by patients

Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml

Other study objectives

Biomarker analysis

Interest expressed in wellness practices

Modes of intervention delivery

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (ETIP)Experimental Treatment6 Interventions

Patients receive nicotine replacement therapy via trans-dermal patch, gum, nasal spray, inhaler or lozenges for 12 weeks in the absence of unacceptable toxicity. Patients also receive bupropion PO QD BID or varenicline PO QD and BID for 24 weeks in the absence of unacceptable toxicity. Patients undergo 3 cessation counseling sessions in person, via telehealth or phone within 7 days of enrollment into study, 1 week after established quit date and 3 weeks after establishing quit date.

Group II: Arm II SOCActive Control3 Interventions

Participants randomly assigned to the standard treatment (ST) group will receive an in-office smoking cessation recommendation by the physician and referral to a quit line.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine

FDA approved

Varenicline

FDA approved

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and traditional chemotherapy. Targeted therapies, such as EGFR inhibitors (e.g., erlotinib, gefitinib), work by blocking specific molecules involved in cancer cell growth and survival, particularly in patients with specific genetic mutations. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells. Traditional chemotherapy, using drugs like cisplatin and etoposide, kills rapidly dividing cells, including cancer cells. Smoking cessation support, as provided in the Enhanced Tobacco Intervention Protocol (ETIP), is crucial because continued smoking can reduce the effectiveness of these treatments and worsen overall prognosis. Comprehensive support including counseling, drug therapy, nicotine replacement, and follow-up can significantly aid in smoking cessation, thereby improving treatment outcomes for NSCLC patients.

Effect of smoking status on progression-free and overall survival in non-small cell lung cancer patients receiving erlotinib or gefitinib: a meta-analysis.