Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
Key facts
- Who runs it
- Ohio State University Comprehensive Cancer Center
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 1 Jan 2024
- Ended
- 31 Jan 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Best Practice
- Nicotine Replacement
- Quality-of-Life Assessment
- Questionnaire Administration
- Record updated
- 12 April 2024
- Why it stopped
- Funding lapse
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Lung cancer patients who are on home supplemental oxygen at baseline
- Patients with nasopharyngeal, thyroid, or gland cancers
- Patients under 21 years of age
- Patients who are cognitively unable to understand the consent form or participate in interviews
- Patients with hearing impairments
- Patients with contraindications to per oral intake
- Patients that have problems with dexterity that would impact electronic cigarette use
- 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 inoperable tumors
- Pregnant women
- Prisoners
Where in United States
- Ohio State University Comprehensive Cancer CenterColumbus, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm I (JUUL)Treatment being tested
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.
Treatment: Nicotine Replacement, Quality-of-Life Assessment, and Questionnaire Administration
- Arm II (usual care)Existing treatment, for comparison
Patients receive usual care.
Treatment: Best Practice, Quality-of-Life Assessment, and Questionnaire Administration
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
- Record updated
- 12 April 2024