- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04694846
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
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19148
- Jefferson Health, Methodist Hospital
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Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Ancillary studies
Given PO
Other Names:
Given PO
Other Names:
Ancillary studies
Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges
Other Names:
Receive counseling
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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.
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Ancillary studies
Ancillary studies
Receive standard treatment
Other Names:
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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
Time Frame: Up to 6 months
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This will be biochemically verified by any reductions in minor tobacco alkaloid (anabasine/anatabine) concentrations in the urine compared to baseline
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Up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cigarette abstinence at 1 and 6 months, as reported by patients
Time Frame: Up to 6 months
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Subjects with missing data will be counted as smokers
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Up to 6 months
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Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml
Time Frame: Up to 6 months
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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.
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Up to 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interest expressed in wellness practices
Time Frame: Up to 6 months
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Descriptive statistics (means and standard deviations for continuous variable and frequencies for categorical variables) will be used to summarize interest in wellness programs.
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Up to 6 months
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Types of wellness practices patients prefer
Time Frame: Up to 6 months
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Up to 6 months
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Likelihood of patient participation
Time Frame: Up to 6 months
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Up to 6 months
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Modes of intervention delivery
Time Frame: Up to 6 months
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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.
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Up to 6 months
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Biomarker analysis
Time Frame: Up to 6 months
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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.
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Up to 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Nicotine
- Bupropion
- Varenicline
Other Study ID Numbers
- 19D.866
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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