Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
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About
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.
Full description
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.
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Volunteers
Inclusion criteria
- Newly diagnosed lung cancer subjects will be stages I-III non-small cell lung cancer (NSCLC) and head and neck cancer subjects will be stages I-IV squamous cell carcinoma (SCC).
- Current smokers of combustible cigarettes who smoke >= 4 days/week.
- Lung cancer patients planning to undergo wedge resection surgery for their index cancer.
- Head and neck cancer patients planning to undergo surgical resection of their index cancer or exploratory biopsies (tonsil cancer).
- Patients must intend to receive ongoing oncology care at Ohio State University [OSU] (i.e., their clinic visit is not a consultation/second opinion).
- Patients that are over the age of 21 years.
Exclusion criteria
- Patients who are cognitively unable to understand the consent form or participate in interviews.
- Patients with hearing impairments.
- Patients who are planning to use or are currently using cessation medication to help quit or reduce smoking.
- Patients who are currently using e-cigarettes.
- Patients undergoing surgery including lobectomy, pneumonectomy, tracheotomy, laryngectomy, or free flap surgery.
- Patients with contraindications to per oral intake.
- Lung cancer patients who are on home supplemental oxygen at baseline.
- Patients that have problems with dexterity that would impact electronic cigarette use.
- Patients under 21 years of age.
- Patients who don't speak and read English.
- Patients with histologies other than NSCLC, or squamous cell carcinoma of the head and neck.
- Patients with nasopharyngeal, thyroid, or gland cancers.
- Patients with inoperable tumors.
- Pregnant women.
- Prisoners.
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
The Ohio State University Comprehensive Cancer Center
Data sourced from clinicaltrials.gov
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