Status:
WITHDRAWN
Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Squamous Cell Carcinoma
Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 di...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05412875
Start Date
January 1 2024
End Date
January 31 2024
Last Update
April 12 2024
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210