This phase II 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04694846.
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.
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorAllison Maria Zibelli
