Lung Non-Small Cell CarcinomaNCT04694846
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
A study testing Nicotine Replacement, Varenicline and Tobacco Cessation Counseling in people with Lung Non-Small Cell Carcinoma and Head and Neck Squamous Cell Carcinoma, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nicotine Replacement, Varenicline and Tobacco Cessation Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2020to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patients not fluent in English will be excluded, as the counselling component of the intervention is only available in English
- Pregnant or breastfeeding women
- Severe swallowing disorders or other illness that would impede a patient's ability to swallow medications in pill form
- Patients with impaired judgement or those unable to provide informed consent
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, 19107
Jefferson Health, Methodist Hospital
Philadelphia, Pennsylvania, 19148
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of implementing a transdisciplinary ETIP using enrollment data and adherence to the intervention.
SECONDARY OBJECTIVE:
- To compare smoking reduction, physiologic parameters and patient reported measures among patients in two tobacco treatment groups (ETIP and standard treatment [ST]).
TERTIARY OBJECTIVE:
- To determine patient interest in wellness practices as a means to alter behavior and facilitate tobacco cessation.
EXPLORATORY OBJECTIVES:
- To analyze the genetic profile, serum and tissue exosomal signatures, and immune cell profiles of both human papilloma virus (HPV) positive and negative tumor samples in patients who are never smokers, former smokers, and current smokers.
II. Compare these parameters in patients who underwent ETIP versus standard therapy.
III. To gather correlative data regarding the effects of tobacco smoke on the expression of biomarkers and the tumor microenvironment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ETIP): 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 orally (PO) once daily (QD) and twice daily (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.
ARM II (ST): Patients receive standard treatment consisting of an in-office smoking cessation recommendation by the physician and referral to a quit line.
- Being tested
- Nicotine Replacement, Bupropion Hydrochloride Controlled-release, Varenicline, Tobacco Cessation Counseling, Questionnaire Administration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine ReplacementDrug
Also called nicotine replacement therapy, Nicotine Replacement Therapy, NRT
Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges
Bupropion Hydrochloride Controlled-releaseDrug
Also called Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban, Zyban
Given PO
VareniclineDrug
Also called 249296-44-4, 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino(2,3-h)(3)benzazepine (2R,3R)-2,3-dihydroxybutqanedioate, Champix, Chantix, CP-526555, VARENICLINE
Given PO
Tobacco Cessation CounselingOther
Receive counseling
Questionnaire AdministrationOther
Ancillary studies
Quality of Life AssessmentOther
Ancillary studies
Best PracticeOther
Also called best practice, standard of care, standard of care, standard therapy
Receive standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ETIP) | Experimental | 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. Receives: Drug: Nicotine Replacement; Drug: Bupropion Hydrochloride Controlled-release; Drug: Varenicline; Other: Tobacco Cessation Counseling; Other: Questionnaire Administration; Other: Quality of Life Assessment |
| Arm II SOC | Active comparator | 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. Receives: Other: Questionnaire Administration; Other: Quality of Life Assessment; Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in daily number of cigarettes smoked by at least 50% compared to baseline at months 1 and 6
This will be biochemically verified by any reductions in minor tobacco alkaloid (anabasine/anatabine) concentrations in the urine compared to baseline
Measured: Up to 6 months
Secondary outcomes (2)
Cigarette abstinence at 1 and 6 months, as reported by patients
Subjects with missing data will be counted as smokers
Measured: Up to 6 months
Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml
Participants will be asked to provide a urine sample for biochemical verification of smoking status with urine anatabine/anabasine testing at baseline, 1 and 6 months. We consider urine anabasine/anatabine less than or equal to 2 ng/ml to be evidence of abstinence. Participant failure to provide a sample will be interpreted as biochemical evidence of smoking.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start19 Aug 2020
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694846
- Sponsor's protocol ID
- 19D.866
- Other IDs
- JT 14301
- Status last verified
- Sep 2025
- First submitted
- 16 Mar 2020
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04694846
- Acronym / sponsor ID
- 19D.866
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of implementing a transdisciplinary ETIP using enrollment data and adherence to the intervention.
SECONDARY OBJECTIVE:
- To compare smoking reduction, physiologic parameters and patient reported measures among patients in two tobacco treatment groups (ETIP and standard treatment [ST]).
TERTIARY OBJECTIVE:
- To determine patient interest in wellness practices as a means to alter behavior and facilitate tobacco cessation.
EXPLORATORY OBJECTIVES:
- To analyze the genetic profile, serum and tissue exosomal signatures, and immune cell profiles of both human papilloma virus (HPV) positive and negative tumor samples in patients who are never smokers, former smokers, and current smokers.
II. Compare these parameters in patients who underwent ETIP versus standard therapy.
III. To gather correlative data regarding the effects of tobacco smoke on the expression of biomarkers and the tumor microenvironment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ETIP): 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 orally (PO) once daily (QD) and twice daily (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.
ARM II (ST): Patients receive standard treatment consisting of an in-office smoking cessation recommendation by the physician and referral to a quit line.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ETIP) | Experimental | Drug: Nicotine Replacement, Drug: Bupropion Hydrochloride Controlled-release, Drug: Varenicline, Other: Tobacco Cessation Counseling, Other: Questionnaire Administration, Other: Quality of Life AssessmentPatients 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. |
| Arm II SOC | Active comparator | Other: Questionnaire Administration, Other: Quality of Life Assessment, Other: Best PracticeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
- Patients not fluent in English will be excluded, as the counselling component of the intervention is only available in English
- Pregnant or breastfeeding women
- Severe swallowing disorders or other illness that would impede a patient's ability to swallow medications in pill form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine ReplacementAlso: nicotine replacement therapy, Nicotine Replacement Therapy, NRTGiven NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges | Drug | Arm I (ETIP) |
| Bupropion Hydrochloride Controlled-releaseAlso: Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban, ZybanGiven PO | Drug | Arm I (ETIP) |
| VareniclineAlso: 249296-44-4, 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino(2,3-h)(3)benzazepine (2R,3R)-2,3-dihydroxybutqanedioate, Champix, Chantix, CP-526555, VARENICLINEGiven PO | Drug | Arm I (ETIP) |
| Tobacco Cessation CounselingReceive counseling | Other | Arm I (ETIP) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (ETIP), Arm II SOC |
| Quality of Life AssessmentAncillary studies | Other | Arm I (ETIP), Arm II SOC |
| Best PracticeAlso: best practice, standard of care, standard of care, standard therapyReceive standard treatment | Other | Arm II SOC |
Primary outcome
Reduction in daily number of cigarettes smoked by at least 50% compared to baseline at months 1 and 6
Time frame: Up to 6 months
This will be biochemically verified by any reductions in minor tobacco alkaloid (anabasine/anatabine) concentrations in the urine compared to baseline
2 secondary outcomes
Cigarette abstinence at 1 and 6 months, as reported by patients
Time frame: Up to 6 months
Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement, Varenicline and Tobacco Cessation Counseling in people with Lung Non-Small Cell Carcinoma and Head and Neck Squamous Cell Carcinoma, run by Thomas Jefferson University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in daily number of cigarettes smoked by at least 50% compared to baseline at months 1 and 6 (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.