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

Study Overview
=================
Brief 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. 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: I. To determine the feasibility of implementing a transdisciplinary ETIP using enrollment data and adherence to the intervention. SECONDARY OBJECTIVE: I. To compare smoking reduction, physiologic parameters and patient reported measures among patients in two tobacco treatment groups (ETIP and standard treatment [ST]). TERTIARY OBJECTIVE: I. To determine patient interest in wellness practices as a means to alter behavior and facilitate tobacco cessation. EXPLORATORY OBJECTIVES: I. 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.

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

Conditions
-----------------
Lung Non-Small Cell Carcinoma, Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Nicotine Replacement
* Drug: Bupropion Hydrochloride Controlled-release
* Drug: Varenicline
* Other: Tobacco Cessation Counseling
* Other: Questionnaire Administration
* Other: Quality of Life Assessment
* Other: Best Practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (ETIP)<br>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. | Drug: Nicotine Replacement<br>* Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges<br>* Other names: nicotine replacement therapy, Nicotine Replacement Therapy, NRT;Drug: Bupropion Hydrochloride Controlled-release<br>* Given PO<br>* Other names: Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban, Zyban;Drug: Varenicline<br>* Given PO<br>* Other names: 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;Other: Tobacco Cessation Counseling<br>* Receive counseling<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality of Life Assessment<br>* Ancillary studies<br>|
| Active Comparator: Arm II SOC<br>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. | Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality of Life Assessment<br>* Ancillary studies<br>Other: Best Practice<br>* Receive standard treatment<br>* Other names: best practice, standard of care, standard of care, standard therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette abstinence at 1 and 6 months, as reported by patients | Subjects with missing data will be counted as smokers | 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. | Up to 6 months |