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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

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine Replacement
Bupropion Hydrochloride Controlled-release
Varenicline
Tobacco Cessation Counseling
Questionnaire Administration
Quality of Life Assessment
Best Practice
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Non-Small Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
  • Jefferson Health, Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (ETIP)

Arm II SOC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cigarette abstinence at 1 and 6 months, as reported by patients
Subjects with missing data will be counted as smokers
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.

Full Information

First Posted
March 16, 2020
Last Updated
August 18, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04694846
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
August 16, 2024 (Anticipated)
Study Completion Date
August 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Non-Small Cell Carcinoma, Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ETIP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II SOC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement
Other Intervention Name(s)
nicotine replacement therapy, Nicotine Replacement Therapy, NRT
Intervention Description
Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges
Intervention Type
Drug
Intervention Name(s)
Bupropion Hydrochloride Controlled-release
Other Intervention Name(s)
Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban, Zyban
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
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
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Tobacco Cessation Counseling
Intervention Description
Receive counseling
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
best practice, standard of care, standard of care, standard therapy
Intervention Description
Receive standard treatment
Primary Outcome Measure Information:
Title
Reduction in daily number of cigarettes smoked by at least 50% compared to baseline at months 1 and 6
Description
This will be biochemically verified by any reductions in minor tobacco alkaloid (anabasine/anatabine) concentrations in the urine compared to baseline
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Cigarette abstinence at 1 and 6 months, as reported by patients
Description
Subjects with missing data will be counted as smokers
Time Frame
Up to 6 months
Title
Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml
Description
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.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Interest expressed in wellness practices
Description
Descriptive statistics (means and standard deviations for continuous variable and frequencies for categorical variables) will be used to summarize interest in wellness programs.
Time Frame
Up to 6 months
Title
Types of wellness practices patients prefer
Time Frame
Up to 6 months
Title
Likelihood of patient participation
Time Frame
Up to 6 months
Title
Modes of intervention delivery
Description
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.
Time Frame
Up to 6 months
Title
Biomarker analysis
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Jefferson Health, Methodist Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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