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

Sponsor

Thomas Jefferson University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04694846

Collaborator

(none)

Enrollment

Locations

Arms

32.4

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Non-Small Cell Carcinoma Head and Neck Squamous Cell Carcinoma	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	N/A

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.
Compare these parameters in patients who underwent ETIP versus standard therapy.
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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 19, 2020

Anticipated Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 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 Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges Other Names: nicotine replacement therapy, Nicotine Replacement Therapy, NRT Drug: Bupropion Hydrochloride Controlled-release Given PO Other Names: Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban, Zyban Drug: Varenicline Given PO 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 Receive counseling Other: Questionnaire Administration Ancillary studies Other: Quality of Life Assessment Ancillary studies
Active Comparator: Arm II SOC 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 Ancillary studies Other: Quality of Life Assessment Ancillary studies Other: Best Practice Receive standard treatment Other Names: best practice, standard of care, standard of care, standard therapy

Arm

Intervention/Treatment

Experimental: 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 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

Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges

Other Names:

nicotine replacement therapy, Nicotine Replacement Therapy, NRT

Drug: Bupropion Hydrochloride Controlled-release

Given PO

Other Names:

Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban, Zyban

Drug: Varenicline

Given PO

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

Receive counseling

Other: Questionnaire Administration

Ancillary studies

Other: Quality of Life Assessment

Ancillary studies

Active Comparator: Arm II SOC

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

Ancillary studies

Other: Quality of Life Assessment

Ancillary studies

Other: Best Practice

Receive standard treatment

Other Names:

best practice, standard of care, standard of care, standard therapy

Outcome Measures

Primary Outcome Measures

Reduction in daily number of cigarettes smoked by at least 50% compared to baseline at months 1 and 6 [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

Secondary Outcome Measures

Cigarette abstinence at 1 and 6 months, as reported by patients [Up to 6 months]
Subjects with missing data will be counted as smokers
Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml [Up to 6 months]
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.

Other Outcome Measures

Interest expressed in wellness practices [Up to 6 months]
Descriptive statistics (means and standard deviations for continuous variable and frequencies for categorical variables) will be used to summarize interest in wellness programs.
Types of wellness practices patients prefer [Up to 6 months]
Likelihood of patient participation [Up to 6 months]
Modes of intervention delivery [Up to 6 months]
Descriptive statistics (means and standard deviations for continuous variable and frequencies for categorical variables) will be used to summarize referred time and method of program delivery.
Biomarker analysis [Up to 6 months]
Immunohistochemistry (IHC) analysis will be done on all patient tissue samples at the initial visit. Additionally, serum blood samples will be collected from all patients. Serum c-reactive protein (CRP) and lipid levels will be tested at various time points in the study to account for changes in inflammatory marker expression. Peripheral blood assays, including Luminex, will be used to quantify immune mediators including expression of interferon (IFN)-gamma, IL-2, and IL-10 among other analytes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy	Philadelphia	Pennsylvania	United States	19107
2	Jefferson Health, Methodist Hospital	Philadelphia	Pennsylvania	United States	19148