NCT04694846Completed
Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use
Feasibility of the Enhanced Tobacco Intervention Protocol (ETIP) to Reduce Smoking and Potentially Alter the Tumor Microenvironment of Head and Neck Squamous Cell Carcinoma and Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
This trial studies how well an enhanced tobacco intervention protocol (ETIP) works compared to standard treatment in helping head and neck and lung cancer patients starting treatment to reduce cigarette use. ETIP is an evidence-based tobacco cessation program including specialized one-to-one and telehealth counseling, drug therapy, nicotine replacement therapy, and frequent patient follow up. ETIP may help reduce smoking and improve cessation in patients with head and neck squamous cell cancer or non-small cell lung cancer.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 16 Mar 2020
- Start date
- Aug 2020
- Primary completion date
- Aug 2024
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT04694846
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From Aug 2020 to the primary completion date, Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to nicotine replacement therapy:
- All free flap patients: Nicotine replacement therapy (NRT) and tobacco products must not be used by these patients for at least 2 weeks before and 2 weeks after free flap surgery. For planned procedures involving face and breast, tobacco and NRT use should be avoided 4 weeks before and 4 weeks after surgery
- Patients in the immediate (within 2 weeks) post myocardial infarction period or who have serious arrhythmias or unstable angina pectoris
- Patient who are hemodynamically or electrically unstable or have had orthopedic surgery or a serious fracture(s) within the past 6 weeks
- Patients with known allergy or hypersensitivity to NRT, or severe skin reactions like Steven's Johnson syndrome
- Contraindications to bupropion or varenicline:
- Pre-existing seizure disorder or conditions that increase the risk of seizures (e.g., severe head trauma, arteriovenous malformation, central nervous system (CNS) tumor (e.g., brain tumor or intracranial mass), CNS infection, severe stroke, anorexia nervosa, bulimia nervosa
- Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
- Concomitant use of anti-depressants
- Patients with known allergy or hypersensitivity to bupropion or varenicline, or severe skin reactions like Steven's Johnson syndrome
Other illness
- Patients with psychiatric disorders with indications of current uncontrolled illness, or patients currently being treated on psychiatric medications
- Patients with expected survival of less than 6 months or other medical illness that would prevent participation as determined by the treating clinician
- Severe swallowing disorders or other illness that would impede a patient's ability to swallow medications in pill form
Other
- Patients not fluent in English will be excluded, as the counselling component of the intervention is only available in English
- Pregnant or breastfeeding women
- Patients with impaired judgement or those unable to provide informed consent
Who the study is looking for
- Provide signed written informed consent document
- New patients opting to receive cancer care at Thomas Jefferson University Hospital (TJUH) or Methodist with suspected or newly diagnosed head and neck squamous cell carcinoma (HNSCC) or non-small cell carcinoma of the lung
- Must have a life expectancy of at least 6 months as judged by the treating physician
- Willing to discuss changing their smoking behavior
- Patients have smoked \> 100 cigarettes in their lifetime and have smoked within the last 30 days
- Subjects must read and speak fluent English
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jefferson Health, Methodist Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.