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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Nicotine Replacement	Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges
DRUG	Bupropion Hydrochloride Controlled-release	Given PO
DRUG	Varenicline	Given PO
OTHER	Tobacco Cessation Counseling	Receive counseling
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Quality of Life Assessment	Ancillary studies
OTHER	Best Practice	Receive standard treatment

Timeline

• Start date: 2020-08-19
• Primary completion: 2024-08-16
• Completion: 2024-08-16
• First posted: 2021-01-05
• Last updated: 2025-09-09

Locations

2 sites across 1 country: United States