This clinical trial investigates the acceptability of electronic cigarettes (JUUL) for smoking cessation (quitting smoking) and the reduction of surgery-related complications in patients with newly diagnosed head, neck, or lung cancer. Smoking before surgery is associated with increased risk of complications during and after surgery. Electronic cigarettes are a type of special product that gives small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking. Stopping cigarette smoking before surgery may reduce the risk of complications during and after surgery in patients with head, neck, or lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05412875.
PRIMARY OBJECTIVES:
I. To evaluate feasibility, acceptability, compliance, and safety of a non-randomized 2-month trial of a pod based electronic cigarette (intervention) versus usual care for stage I-III lung cancer patients and stage I-IV head and neck cancer patients undergoing surgical resection.
II. Examine the effect of the pod based electronic cigarette (intervention) on surgical complications, quality of life, and whether it promotes complete or incomplete switching to the non-combustible product.
OUTLINE: Patients choose to participate in 1 of 2 arms.
ARM I: Beginning 1 month before surgery, patients receive a JUUL e-cigarette and a 1 month supply e-liquid pods. After completion of surgery, patients receive another 1 month supply of e-liquid pods.
ARM II: Patients receive usual care.
After completion of study intervention, patients are followed up at 2 and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorTheodore Brasky