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A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
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.
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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Start Date
January 1, 2024
Primary Completion Date
January 31, 2024
Completion Date
January 31, 2024
Last Updated
April 12, 2024
Best Practice
OTHER
Nicotine Replacement
DRUG
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
NCT03191149
NCT06980038
Data Source & Attribution
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